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Effects of Electrical Stimulation (FES) with Exercise Therapy (ET) on Hand Function in Spinal Cord Injury Patients

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Published: 9th Dec 2019

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Does functional electrical stimulation (FES) with exercise therapy (ET) lead to improvement in hand function in patients with spinal cord injury (SCI)?

Definition of Evidence Based Practice (EBP)

In this advanced technology era with high responsibility on healthcare professions, Evidenced Based-Practice (EBP) plays an important role to provide a framework within which to work to enhance the proficiency of physiotherapists’ clinical practice and help to prevent the misuse, overuse and underuse of healthcare services (Scurlock-Evans et al., 2014). Sackett and colleagues (1996) defined EBP as “…the conscientious, explicit and judicious use of the current best evidence in making decisions about the care of individual patients”. They described further as it is the interaction between the individual clinical expertise and patient values with the best available external clinical evidence from systematic research which when applied by practitioners will ultimately lead to improved patient outcome (Sackett et al., 1996). It consists of 5 step process to assimilate the scientific evidence – Ask, Acquire, Appraise, Apply and Assess (Condon et al., 2016).

According to World Health Organization (2013), spinal cord injury (SCI) results from the damage to spinal cord caused by trauma or non-trauma (disease or degeneration) with an estimation of 250,000–500,000 people suffer it around the world each year. It affects 50,000 people in United Kingdom (UK) especially young adults and 80% of them are male (Patil et al., 2015). Studies showed the injury to cervical level of spine, incomplete injury, tetraplegia, America Spinal Injury Association Impairment Scale (ASIA) A or B motor-complete injuries for traumatic SCI and C or D motor-incomplete injuries for non-traumatic injury are more common (Kang et al., 2017). It is a high disabling and cost injury that results in sensation and motor function damage or loss and multiple organ dysfunction (Kang et al., 2017).

Both upper and lower limbs are affected is known as tetraplegia and caused by a cervical level of SCI. Patients in this group were unable to carry out basic activities of daily living (ADL) and express themselves through gestures or touch. Therefore, the main priority goals of rehabilitation for tetraplegia patients were to regain and improve their hand functions and reduce reliance on others (Patil et al., 2015). A sequence of exercise program can increase upper limb function to make a big difference in someone’s life (Beekhuizen et al., 2008). It was difficult to ensure the patients conducted the exercises regularly at home as they tended to get bored and the therapists were unable to supervise them all the time (Kern et al., 2010).

On the other hand, functional electrical stimulation (FES) is one of the assistive device used in physiotherapy intervention in order to restore or increase hand function following a SCI. The electrodes can apply in two ways, implanted or surface. Implanted FES systems consist multichannel stimulation systems controlled by voluntarily controlled electrical stimulation by implanted it in the upper limb to produce the movement (Biering-Sørensen et al., 2015). In 1986, the first implanted FES was introduced as Freehand in Cleveland, OH, USA but it was no longer available (Cornwall et al., 2004). Thus, this review will only focus on the surface FES systems. It involved a microprocessor to control the multiple-channel electrical stimulator (Freixes et al., 2017). They stimulated the innervated muscles to contract or produce the expected function and trigger the action potential in the motor nerve (Thorsen et al., 2006). The participants in FES group showed significantly greater improvements in the outcome measure after the intervention (Burns et al., 2017). However, there is only a few controlled trials studied on the effectiveness and protocol of FES making the evidence difficult to apply successfully in the clinical setting (Patil et al., 2015).

Question in Chosen Area of Practice

When forming an appropriate literature review question in my chosen area of practice, PICO framework was used to guide in this process (Thompson, 2012). This strategy helped to develop a classification of evidence (Robinson et al., 2011).

“Does functional electrical stimulation (FES) with exercise therapy (ET) lead to improvement in hand function for patients with spinal cord injury (SCI)?”

Problem (P): Patients with SCI

Intervention (I): FES and ET

Comparator (C): Conventional exercise therapy but without FES

Outcome (O): Improvement in hand function

The reason this topic chosen was to sort out a beneficial and feasible protocol, provide comprehensive evidence and suggest an action plan to implement the change in the delivery of FES with ET to the clinical setting. Moreover, it will be beneficial for my future career as a physiotherapist in neurological filed. Besides, it provides me with extra knowledge and understanding on the physiotherapy intervention especially using FES and ET in regaining hand function for the patients with SCI.

Databases Searched and Search Terms Used

‘PRIMO’ via Plymouth University which is the primary online catalogue I used to search systematically for the literature following by the other online platforms such as Ebsco and Ovid.  In order to search the relevant clinical evidence in my chosen area of practice, the following databases were carried out, CINAHL, PubMed, Web of Science and Cochrane Library. The search terms or keywords used for search were spinal cord injury, functional electrical stimulation and hand function. Then, the following terms that related to the above searched terms were added: SCI, tetraplegia, FES, exercise therapy and hand rehabilitation. The search only included the research published between 2008 and 2018.

Reasons for Selected Research Evidence for Review and Reject

A total of 172 articles were found. Additional hand searching of additional 3 relevant articles were identified. The evidence inclusion criteria were:

  1. Sustaining a complete or incomplete SCI patients at the cervical and high thoracic level (C2 to T1)
  2. Within 1 year after the injury
  3. Limited to adults and human studies
  4. Reduced or loss of hand function
  5. Evaluating the effect of FES

Besides, the papers published less than 10 years (2008-2018) were included. Hierarchy of evidence was applied to better understand the quality of methodological of the studies. The appropriate study design always determined by the well-built clinical question (Richardson, 1995). Based on the hierarchy of evidence, only high level of journal articles met the criteria of this assignment. Therefore, randomization controlled trials (RCT) or systematic reviews were used. CASP tools were utilized to appraise the articles critically.

In addition, it was important to choose valid and reliable outcome measures. Variety upper limb functional tests were widely used to assess the hand function in SCI population after the intervention. The activities domain was assessed by Action Research Arm Test (ARAT), Functional Independence Measure (FIM) and Spinal Cord Independence Measure (SCIM). While the domain of body functions and structures was recorded using Graded Redefined Assessment of Strength, Sensitivity and Prehension (GRASSP) and Toronto Rehabilitation Institute Hand Function Test (TRIHFT). The more specific functions were evaluated by Grasp and Release Test (GRT) and ReJoyce automated hand function test (RAHFT).

However, evidence which did not relevant to my PICO question were rejected from this review such as other neurological conditions, implanted FES, undergone surgical treatment, addressed children rather than adults, other than hand function and above outcome measures. In addition, papers conducted in basic data set, guidelines, case reports, theoretical perspectives or animal trials were discarded as they were not suitable for this assignment. Some articles without full text available were excluded.

Thus, 7 relevant research evidence (5 RCTs and 2 systematic reviews) were found and met the inclusion criteria for review in this assignment. It was not possible to include all the articles due to the limitation of words and time.

Discussion on Findings, Detailed Critical Evaluation, Strengths and Weaknesses of the Research Evidence

Through the selected research evidence, many studies had shown positive outcomes in hand function in SCI patient with applying FES with ET compared to conventional ET (Harvey et al., 2011; Kapadia et al., 2011; Kowalczewski et al., 2011; Popovic et al., 2011). However, a recent paper was suggested that this intervention did not lead to improvement in hand function in SCI patient (Harvey et al., 2017).

Harvey and colleagues(2011) conducted a multicentre, RCT by using an intensive task-specific hand-training program and FES with standard care to improve hand function in SCI tetraplegia patients. This study clearly demonstrated the inclusion and exclusion criteria of patients’ recruitment, FES parameters and outcome measurements. With this, it increased the patient engagement, reliability and external validity to the practice by utilizing the gold standard tools. It was carried out in both Australia and New Zealand where practices may be slightly different. Different practices may have different guidelines to carry out the assessments and interventions and led to bias in the result. So, it was important to closely examine the processes and procedures before conducting the study. When performing the primary outcome, they involved the treatment group and site as factors and the baseline ARAT score as a covariate. The mean difference between intervention and control group for ARAT score at 8 weeks was 5.7 points, a two-sided hypothesis test, an alpha level of 5%, and a standard deviation of 14 points. This showed minimal improvement in the hand function by using this intervention. It was necessary to further investigate the benefits of FES and appropriate protocol in regaining of hand function in SCI patients. They included the data of participants in both groups who received at least 80% of the treatment to raise the reliability of the trial. However, they estimated 10% drop-out rate from this large sample size (78 participants) were allowed but did not mention the real value. It can affect the reliability of the result as how many participants were involved in the follow-up period was unclear. Although, the secondary outcomes which were taken at 6 months and 12 months after the intervention may be affected as the patients can choose to be or not be involved in sessions with the therapist and care providers after 8 weeks intervention period. Multiple imputation analysis was undertaken to avoid missing data that may lead to bias. They minimised bias by allocating the participants randomly, providing the treatment and measuring outcomes by blinded assessors to the group, analysing performed on an intention-to-treat basis and asking assessors to guess participants’ group allocations to estimate the successfulness of the blinding.

Furthermore, Kapadia et al. (2011) identified FES therapy had led to improvement in hand grasping function in traumatic incomplete SCI (At cervical level C4-C7) patients in a single-site RCT. This study was conducted within a small sample size and able to obtain the subgroup analysis (Eg. Age, sex, severity and level of SCI and time since SCI) to display high sensitivity of homogeneity. It increased the high methodological quality and strengthen clinical significant of the result. They showed the SCI patients had statistically significant improvement in their hand function at 8 weeks after the intervention by using FIM self-care scores (P value=0.015), SCIM upper extremity sub-score (P value˂0.0001) and TRIHFT total score for manipulation of 10 objects (P value=0.054) compared to the control group. There was a data loss in one of the outcome measures (TRIHFT) at 6 months after the treatment due to the technical shortcomings. This can affect the external validity of the study when threatening the generalization from the sample studied to the target population. Besides, the outcome measures at 6 months after the treatment were underpowered because participants were dropped out for the long-term assessments. This can make the long-term effectiveness of FES difficult to research in this area of study. However, it didn’t affect the reliability of the result as the completion of 5 individuals for the long-term follow-up assessment at 6 months after the treatment shown an ability to maintain and improve further their voluntary hand function.

Additionally, the feasibility of providing In-home Tele-therapy (IHT) over internet was evaluated in a blocked-RCT (Kowalczewski et al., 2011). It compared 2 different treatments at different time points in a crossover design.13 participants were divided in group 1 (6 weeks of conventional ET, 1-month washout and then 6 weeks of ReJoyce ET) and group 2 (6 weeks of ReJoyce ET, 1-month washout and then 6 weeks of conventional ET). Each subject in this design study served as their control to significantly decrease between-subject variability and detect the smaller effect sizes with less sample size. The result was considerably more power in non-treatment related factors as they were examined the relevant patient population with appropriate treatment. Unfortunately, the second treatment had order effects and carry-over effect on the outcome of interest. Moreover, the washout period was too short to allow the hand function to return to normal condition. It meant that the result of the first treatment which sustained for a long time may affect the reliability of the second treatment’s result. The mean ARAT scores for ReJoyce ET at week 6 improvement was decreased from 17.5% in group 2 to 13.3% in group 1. Nonetheless, both ARAT (P value˂0.01) and RAHFT (P value˂0.01) scores improved more after ReJoyce ET than after conventional ET. There was no dropout at the 30-week follow-ups though it was a longer period study which can increase the reliability of the result.

In another single-site RCT, Popovic and colleagues (2011) compared the efficacy of FES with conventional occupational therapy (COT) to COT alone in improving grasping function among patients with tetraplegia secondary to sub-acute traumatic incomplete SCI (C4-C7, ASIA B-D). A small sample size of 24 participants was carried out with larger variability. The randomization schedule was done by the randperm function in Matlab (The Mathworks Inc, Natick, Massachusetts) seeded with an arbitrary clock value. The procedures of screening of subjects, providing treatments and outcome assessments were conducted by blinded assessors. The bias can minimize by applying these above procedures. This evidence increased its sensitivity of homogeneity and quality of the trial by successfully analysed the participants’ impairments and demographic characteristics in this small sample size by using descriptive statistics for parametric and nonparametric data. Some denervated muscles in some subjects cannot be contracted by utilizing FES and therefore they had to stimulate other difference muscle group combinations which also can produce the target hand movement. Each participant had particular muscle group stimulation protocol which not all the muscles listed were stimulated in the particular participant. This may affect external validity to generalise the result in the clinical setting. The intervention group demonstrated a significant reduction of disability and greater improvements in hand function in FIM self-care sub-score (P value=0.015) and SCIM self-care sub-score (P value< 0.0001). A high drop-out rate of the participants (79.2%) from this small sample size didn’t involve in the 6-month follow-up assessment as most of the subjects were discharged home and far from the study site to receive the long-term care facilities. It affected the reliability of the result in this trial. Thus, future studies are required to clarify the long-term outcomes of FES in regaining hand function in SCI patients.

Nevertheless, a recent multi-centre, RCT evaluated the early intensive hand rehabilitation and usual care plus one-to-one hand therapy in people with sub-acute SCI. (Harvey et al., 2017). The sample size (70 participants) of this study was large enough to generalize the result from this group to the specific population. It powered the external validity of the result. The method used and blinded assessors in this trial reduced bias and made it very transparent. This evidence increased its feasibility by conducting the study according to Good Clinical Practice standards which is uncommon for non-pharmaceutical trails involving SCI people. The usual care was not standardised but individualised to the need of participants by the hospital therapists. It can decrease the reliability of result when usual care compared to the intervention as the different subject had different hand therapy. Both selection model (modelling of the missing data mechanism) and a pattern mixture model (modelling of the differences between missing and observed data) were used to assess the missing data and sensitivity of the results to plausible departures from the missing-at-random assumption as a part of intention-to-treat analysis. Assessors were accidentally found un-blinded for two assessments which may influence the measurement and interpretation of the data. The mean difference for m-ARAT scores of pre-intervention (0.9 points 95% (Confidential Interval (CI) –4.1 to 5.9) and post-intervention (0.9 points, 95%CI – 4.5 to 6.4) was very similar. There was no statistically significant difference in treatment effect between the participating centres in m-ARAT scores and all secondary outcome measures. Other possible therapeutic effects of FES and the effects of intensive practice provided in different ways needed to be considered and explored.

Is It Appropriate for Chosen Area of Practice?

When looking into the appropriateness of the evidence to the chosen area of practice, a discordance in the efficacy of FES and ET in the acute, sub-acute and chronic stage of SCI was pointed out. The results may differ when evaluating the intervention in people with different stages of SCI (Harvey et al., 2017).

Fehlings et al. (2017) suggested that the extent to which stakeholders focus key outcomes was no significant uncertain and variable. The desirable anticipated effects were large to affect the result in improvement in the outcome measures. However, they agreed that FES was an inexpensive small equipment with less extensive training required, potential large benefit, reduced health inequities and low risks.

Besides, physical environment or setting of the studies may be one of the variables of this intervention. Two studies were undertaken in in-patient rehabilitation SCI units which received the authors’ clinical attention most closely. One trial was carried out in IHT over internet which supervised and instructed by the trained physical therapist to maintain the same standard of care. Whilst two other studies didn’t mention clearly where they were carried out.

In order to conduct this intervention effectively in this clinical setting, trained healthcare professional with adequate knowledge of FES and ET was needed to deliver the treatment to the patients (Popovic et al., 2011). The outcome measures with qualitative components were prone to rater bias (Prochazka et al., 2015). Therefore, clinical outcome measures with quantitative components were utilized in those studies to determine the clinical significant changes.

A clear subgroup analysis was essential in the trial to improve the sensitivity of homogeneity, quality of methodological, clinical significance of result and level of the evidence. The intervention and control group were compared with subjects’ characteristics and demographics at the onset of the studies. They were compared according to the age, sex, severity, cause of SCI, level of injury, time since injury, completeness of injury, hand dominance, hand most functional post-injury, treated hands, distance from testing site and wireless network used (Harvey et al., 2011; Kapadia et al., 2011; Kowalczewski et al., 2011; Popovic et al., 2011; Harvey et al., 2017). Fisher’s exact test and Mann–Whitney U-test were used to compare categorical variable and continuous variables respectively.

Harvey et al. (2017) suggested that 8 weeks intervention period with 40 hours was an ideal protocol in this practice. During the intervention period, if the subjects missed any treatments, they had to attend in additional sessions on weekends or extra week at the end of the intervention period. However, it was difficult to have additional I hour due to other treatments were in the planned schedule. Other issues like participants’ illness, lack of staff and failure of equipment may affect the intervention.

Most of the participants included in those trials were able to complete the intervention with one hour per day, 5 days per week for the 8 weeks intervention period (Harvey et al., 2011; Kapadia et al., 2011; Kowalczewski et al., 2011; Popovic et al., 2011). This suggests it was feasible to conduct in the clinical setting. Although the data of follow-up long-term effect of the intervention were limited, it was assumed that FES would be effective to improve and maintain hand function in SCI patients if and only if they had undergone 40 sessions treatment. The issues of maintaining improvement over the long-term and making a significant difference in patients’ life would be changelings to study on the patients.

Action Plan and the Opportunities and Limitations for Changing Practice in Chosen Area of Practice

The action plan was necessary for this review to discuss the opportunity and limitation to change the practice in this related field. In order to achieve patient care and staff satisfaction, the health professions must provide the most appropriate interventions based on the high level of evidence. The 7-step RAPSIES change management model (Gopee & Galloway, 2009) used to discuss the action plan. It enabled the change implemented effectively in the clinical practice and easy to understand and contributed for personal development in this career.


With increasing the number of SCI patients, the therapists unable to fully supervise individual patient at the same time in the rehabilitation. The therapists were found lack of training, peer review and counselling. The 9-hour working hour restricted the therapists to provide the effective treatment to the patient every day. No standardized protocol or guideline of the FES and ET in providing the treatment to the patients. Lack of patients’ involvement and education in the intervention had increased the therapists’ burden and affected the efficacy of the treatment.


A six different users of change Rogers and Shoemaker (1971) was tabulated in Appendix 1. Innovators needed motivation, recognition for compliance and support from the organizational antecedents. As it progressed, the rejecters were the most challenging aspect to the innovators but they began to accept at the later stage. This increased the support among the groups and motivation. The targets and satisfaction of therapists helped to fully commit.


Gopee and Galloway (2009) suggested that a change agent (current therapists or external facilitator) should be identified, recommended, led and implemented the change. In this practice, the therapists were more understanding to the role of FES and ET. They had to communicate the key messages and display an effective transformational leadership skill for better understanding and cooperation.

Strategies & Implementation

One-to-one therapy would be the first place for the implementation of FES with ET in the clinical setting (Harvey et. al., 2017). This will ensure the intervention is carried out in a standard way. The therapists involved in the intervention can adjust the electrode placement, guide the correct or precise hand movements and encourage the patients.

Furthermore, the training, peer review and counselling for the therapist are needed to integrate these skills into regular practice. These strategies will help the therapists to improve their skills and confidence and identify the possible problems in providing the treatments. A multidisciplinary team which including the nursing staff is critical in implementing the intervention successfully. The adequate knowledge and training can be provided to them by the therapists in the wards. With this, they can communicate with other healthcare professions to elicit a desired appropriate treatment for patients. It also improves expanding knowledge in other fields as well, as medical field is ever-expanding.

Besides, an appropriate protocol with parameters of FES and ET and time needed for the intervention is essential. A standard guideline is the best resource for implementing the EBP into the clinical setting (Proffitt, 2016). It also leads the therapist to have better decision making.

According to the EBP, it is important to incorporate the patients actively in the intervention. The patients have their right to understand the condition and treatment given to them and also make the decision. The patients’ goals in the rehabilitation will guide the treatment planning, strategies and choice of activities (Proffitt, 2016). Moreover, self-management would be another method in carrying out the interventions successfully. The patients are advised to perform the exercises at their own time to enable the treatments are provided continuously, have a long-term effect and reduce the therapists’ burden. Education for the patients and caregivers are suggested in the intervention in order to achieve high rates of compliance with the intervention.

Evaluating the Change

The step of evaluation is to ensure the change implemented in this practice successfully. Thus, the effects of the treatment and change are evaluated by using the outcome measures (Appendix 2) before and after the intervention. Besides, the discussion between the multidisciplinary team provides a platform to discuss the pros and cons of the intervention. The questionnaire can also be provided to collect the feedback from all the people who involved in this practice.

Sustaining the change

After the evaluation has been done, the action plan will be reviewed and changed the intervention where appropriate to this clinical practice.

Unfortunately, there is always difficult to implement the change in the clinical setting. One of the biggest limitations is the therapists always lack of time to provide the one-to-one therapy, attending and providing the training and searching for the updated evidence. Rehabilitation is a heavy workload and requiring a long period. They have to really supervise the patients’ treatment to ensure a better outcome. In addition, it is suggested to start the rehabilitation for the SCI patients as soon as possible. But, it is dependent on the rehabilitation facilities and sequence of patients in the unit. Some rehab unit will not have adequate equipment needed for FES and ET. This intervention reviewed in this study may be not tailored to every patient especially for the psychiatric illness. They are unable to concentrate and perform the exercises correctly.












This review had been studied on the use of FES and ET in SCI patients and an action plan to implement the intervention in SCI rehabilitation unit. It is always difficult to fully apply the evidence to the practice due to various protocols and opinions. Thus, the therapists have to critically appraise the high levels of evidence to the clinical setting. Most of the evidence had proven that the use of FES and ET improve the hand function in SCI patients. However, the long-term effect of this intervention is unclear and suggested to future study. Implementation of change to the practice is often a slow and tough process. Nevertheless, as a physiotherapist in this carer, it is our responsibility to work in the best practice area in order to provide an appropriate treatment for patients’ best. Every support from the different range of people is essential to provide a step for the implementation of change to the practice successfully.


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Appendix 1

Table 1. 6 different users of change (Rogers and Shoemaker, 1971)

Innovators People who willing to experience new ideas, suggest the implemented change in the practice and assess the potential benefit.
Early Adopters Leaders who provide advice or information about the change.
Early Majority People who adopt the idea, start the change in the practice and improve awareness.
Later Majority People are less anxious and critical and begin to realize the benefits.
Laggards People who spend longer in the service, have a traditional view and unaware of the problems.
Rejecters People who have many years’ experience in this practice, oppose the change and uncomfortable for the change.
















Appendix 2

Table 2. Outcome measures and functions

Assessment Rationale
Action Research Arm Test (ARAT) A standardised measure of unilateral hand and upper limb function which consists of 4 sub-tests (grasp, grip, pinch and gross movement). It has high reliability and validity in assessing a range of functional hand tasks.
Functional Independence Measure (FIM) To measure the degree of disability for daily self-care.
Spinal Cord Independence Measure (SCIM) To evaluate the ability to perform basic everyday tasks. It consists of 6 items (feed, bathe upper body, bathe lower body, dress upper body, dress lower body and groom.
Graded Redefined Assessment of Strength, Sensitivity and Prehension (GRASSP) To assess upper limb strength of the target hand. It consists of a 6-point manual muscle test to score for 9-joint actions (shoulder flexion, elbow flexion, elbow extension, wrist extension, finger flexion, finger extension, finger abduction, thumb flexion, and thumb opposition).
Toronto Rehabilitation Institute Hand Function Test (TRIHFT) To evaluate the gross motor function of unilateral grasp. It consists of 3 components (power grasp, the lateral pinch and precision grip, strength of both power and lateral grasps).
ReJoyce automated hand function test (RAHFT) A test that performed on the ReJoyce workstation with audiovisual prompts and reminders generated by interactive

Software. It consists of 3 parts (functional ranges of motion (fROM), functional tasks and placement tasks).

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Content relating to: "Neurology"

Neurology is the specialist branch of medicine that deals with the treatment of disorders of the nervous system. This means that neurologists concern themselves with issues affecting the brain, the nerves, and the spinal cord.

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