Spinal Cord Injury CervicalFESNCT03048331
Functional Electrical Stimulation (FES) and Reconstructive Tetraplegia Hand and Arm Surgery
A study testing Functional Electrical Stimulation in people with Spinal Cord Injury Cervical, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial summary
FES is a common and established method in the rehabilitation of persons with spinal cord injury (SCI). Some known effects of FES were investigated in several studies e.g. avoiding disuse and denervation atrophy, improving muscle force, power output and endurance changing muscle fibre type, increasing cross sectional… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury Cervical
- What is being tested?
- Functional Electrical Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2017to 19 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- traumatic or non-traumatic (> 6 month) spinal cord injury
- Age ≥ 18 years
- Level of lesion C4 - Th1
- American Spinal Cord Injury Association Impairment Scale (AIS) A/B/C/D
- Planned reconstructive hand or arm surgery at the Swiss Paraplegic Centre Nottwil
- Signed informed consent
Who cannot join
- Patients during primary rehabilitation
- Patients' inability to follow the study, e.g. mental-health problems, language problems, dementia etc.
- Pregnancy (anamnestic)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Paraplegic Centre
Nottwil, Canton of Lucerne, 6207
About this study
Official title: The Effect of Functional Electrical Stimulation (FES) in Tetraplegia Reconstructive Surgery of the Upper Limbs - A Pilot Study
FES is a common and established method in the rehabilitation of persons with spinal cord injury (SCI). Some known effects of FES were investigated in several studies e.g. avoiding disuse and denervation atrophy, improving muscle force, power output and endurance changing muscle fibre type, increasing cross sectional area of muscle, increasing muscle mass, activation of nerve sprouting, reducing spasticity and motor learning.
Most of the studies investigated the impact of FES in the lower limbs. For the upper extremities fewer studies exist. However, it is supposed that the effects of FES are similar.
In the rehabilitation of persons with tetraplegia, FES, especially the stimulation of the upper extremities triggered by electromyography (EMG) is an established method to generally improve hand and arm function. However, none of those studies has investigated the effect of FES in combination with reconstructive tetraplegia hand surgery. Improved muscle strength is supposed to improve the functional outcome in participation. Additionally, FES could increase the motor learning process. Supported by the clinical observation we hypothesize that FES has a positive influence on the outcome of surgical reconstruction of tendon and/or nerve transfers.
Read the detailed description
In the rehabilitation of patients with a tetraplegia, FES is a common used method to improve the function of the arms and hands. The effects of FES also gain in importance considering the procedure of reconstructive arm and/or hand surgery in tetraplegic patients. The functioning of arm and hand muscles can be improved by surgically inverting intact muscles. Therefore, strengthening of the donor and recipient muscles with FES seems to be reasonable. So far it is not established if systematic training with FES before and after reconstructive hand and arm surgery could additionally improve the outcome in terms of strength, motor learning and function. However, clinical observations show a possible positive effect of FES.
The aim of the present randomized controlled study is to evaluate the use of FES before and after a reconstructive arm and/or hand surgery in order to increase the strength of the donor and recipient muscles, and thus, improving the result regarding strength and functionality.
A total of 30 tetraplegic patients who are planned to have a reconstructive arm and/or hand surgery at the Swiss Paraplegic Centre will be included into the study. The participating subjects will be randomized into two groups: a control and an intervention group.
The control group (15 patients) will receive defined standardized physio- and occupational therapy after the surgery. The intervention group (15 patients) will receive a combination of standardized physio- and occupational therapy and FES, before and after surgery. The standardized therapy will be supplemented with FES for 3 months, 3 x 30min per week.
To verify the effects of FES on muscular strength and functionality of the arms and hands, several assessments will be conducted at 4 different time points (T1: 12 weeks before surgery // T2: just before surgery // T3: 4 weeks post-surgery // T4: 16 weeks post-surgery). The course of the voluntary muscular strength and the strength generated by FES of both, the donor and the recipient muscle will be measured. In addition, the change in muscle volume in forearm and upper arm will be assessed by ultrasound. Furthermore, a standardized test to check several grasping action will be performed and there will also be a manual testing of the muscles in arms and hands.
Statistical analysis of these assessments enable an estimation of the benefit and effect of FES as an additional therapy in the context of reconstructive arm and/or hand surgery for tetraplegic patients.
- Conditions
- Spinal Cord Injury Cervical
- Being tested
- Functional Electrical Stimulation
- Keywords
- Functional Electrical Stimulation, Tetraplegia, Reconstructive Hand Surgery
- Medical subject headings
- Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Electrical StimulationDevice
Functional electrical stimulation is applied with stimulators according to the lesion. In case of a upper motor neuron lesion the stimulation operates via nerve. For the stimulation surface electrodes are placed on the skin over the muscle belly. The stimulation of the innervated muscles will be conducted using the following conditions:
300-400 usec, 20-50 Hz, amplitude depends on the quality of muscle contraction (20-80 mA). the duty cycle of the stimulation is 3 sec. ramp up, 5 ec. plateau, 2 sec. ramp down, 10 sec. pause.
| Study group | Role | What they receive |
|---|---|---|
| Functional Electrical Stimulation | Experimental | Before surgery, the donor muscle is stimulated via surface electrodes in a loaded position or against resistance 3 times a week for 30 minutes.
After surgery, the patients receive the same standard therapy as the control group. The electrical stimulation is performed once a day in combination with standard therapy for 30 minutes against gravity or resistance or in a loaded position. Receives: Device: Functional Electrical Stimulation |
| Standard therapy | No intervention | Postoperatively, 20 min passive and active movements of the hand or arm are applied manually by a therapist. Additionally, the patients actively perform the same exercises once a day for 20 min. The movements are based on a standardised post-surgical treatment protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in evoked force
Change in voluntary and electro-stimulated evoked force (torque Nm) for the recipient muscle
Measured: 12 weeks before surgery, 1 day before surgery, 4 weeks post-surgery and 16 weeks post-surgery
Change in power output
Change in voluntary and electro-stimulated power output (W) for the recipient muscle
Measured: 12 weeks before surgery, 1 day before surgery, 4 weeks post-surgery and 16 weeks post-surgery
Secondary outcomes (4)
Change in Canadian Occupational Performance Measurement (COPM)
Changes of functional outcomes (i.e. performance and satisfaction) of the treated upper limb before and after surgery
Measured: 2 weeks before surgery, 1 day before surgery and 16 weeks post-surgery
Change in muscle volume
Difference in muscle volume of the treated limb before and after surgery measured by ultrasound
Measured: 2 weeks before surgery, 1 day before surgery and 16 weeks post-surgery
Change in the treatment effectiveness
Questionnaire of the participant's perception of the treatment effectiveness to evaluate the benefit of FES according to effort of the treatment
Measured: 2 weeks before surgery, 1 day before surgery and 16 weeks post-surgery
Change in muscle activity
Change in the muscle activity of a transferred muscle in a new function surface assessed by EMG
Measured: 4 weeks post-surgery and 16 weeks post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start1 Mar 2017
- Primary completion19 Nov 2025
- Study completion19 Nov 2025
Why it stopped: Inability to recruit further study participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injury CervicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jan Fridén, Prof. Dr. med., Principal investigator, Swiss Paraplegic Centre Nottwil, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03048331
- Sponsor's protocol ID
- 2015-06
- Acronym
- FES
- Status last verified
- Nov 2025
- First submitted
- 7 Feb 2017
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Functional Electrical Stimulation (FES) in Tetraplegia Reconstructive Surgery of the Upper Limbs - A Pilot Study
- ClinicalTrials.gov ID
- NCT03048331
- Acronym / sponsor ID
- FES / 2015-06
- Conditions
- Spinal Cord Injury Cervical
- Keywords
- Functional Electrical Stimulation, Tetraplegia, Reconstructive Hand Surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to recruit further study participants
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 19 Nov 2025 (actual)
- Study completion
- 19 Nov 2025 (actual)
- First posted
- 9 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
FES is a common and established method in the rehabilitation of persons with spinal cord injury (SCI). Some known effects of FES were investigated in several studies e.g. avoiding disuse and denervation atrophy, improving muscle force, power output and endurance changing muscle fibre type, increasing cross sectional area of muscle, increasing muscle mass, activation of nerve sprouting, reducing spasticity and motor learning.
Most of the studies investigated the impact of FES in the lower limbs. For the upper extremities fewer studies exist. However, it is supposed that the effects of FES are similar.
In the rehabilitation of persons with tetraplegia, FES, especially the stimulation of the upper extremities triggered by electromyography (EMG) is an established method to generally improve hand and arm function. However, none of those studies has investigated the effect of FES in combination with reconstructive tetraplegia hand surgery. Improved muscle strength is supposed to improve the functional outcome in participation. Additionally, FES could increase the motor learning process. Supported by the clinical observation we hypothesize that FES has a positive influence on the outcome of surgical reconstruction of tendon and/or nerve transfers.
Detailed description
In the rehabilitation of patients with a tetraplegia, FES is a common used method to improve the function of the arms and hands. The effects of FES also gain in importance considering the procedure of reconstructive arm and/or hand surgery in tetraplegic patients. The functioning of arm and hand muscles can be improved by surgically inverting intact muscles. Therefore, strengthening of the donor and recipient muscles with FES seems to be reasonable. So far it is not established if systematic training with FES before and after reconstructive hand and arm surgery could additionally improve the outcome in terms of strength, motor learning and function. However, clinical observations show a possible positive effect of FES.
The aim of the present randomized controlled study is to evaluate the use of FES before and after a reconstructive arm and/or hand surgery in order to increase the strength of the donor and recipient muscles, and thus, improving the result regarding strength and functionality.
A total of 30 tetraplegic patients who are planned to have a reconstructive arm and/or hand surgery at the Swiss Paraplegic Centre will be included into the study. The participating subjects will be randomized into two groups: a control and an intervention group.
The control group (15 patients) will receive defined standardized physio- and occupational therapy after the surgery. The intervention group (15 patients) will receive a combination of standardized physio- and occupational therapy and FES, before and after surgery. The standardized therapy will be supplemented with FES for 3 months, 3 x 30min per week.
To verify the effects of FES on muscular strength and functionality of the arms and hands, several assessments will be conducted at 4 different time points (T1: 12 weeks before surgery // T2: just before surgery // T3: 4 weeks post-surgery // T4: 16 weeks post-surgery). The course of the voluntary muscular strength and the strength generated by FES of both, the donor and the recipient muscle will be measured. In addition, the change in muscle volume in forearm and upper arm will be assessed by ultrasound. Furthermore, a standardized test to check several grasping action will be performed and there will also be a manual testing of the muscles in arms and hands.
Statistical analysis of these assessments enable an estimation of the benefit and effect of FES as an additional therapy in the context of reconstructive arm and/or hand surgery for tetraplegic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional Electrical Stimulation | Experimental | Device: Functional Electrical StimulationBefore surgery, the donor muscle is stimulated via surface electrodes in a loaded position or against resistance 3 times a week for 30 minutes. After surgery, the patients receive the same standard therapy as the control group. The electrical stimulation is performed once a day in combination with standard therapy for 30 minutes against gravity or resistance or in a loaded position. |
| Standard therapy | No intervention | –Postoperatively, 20 min passive and active movements of the hand or arm are applied manually by a therapist. Additionally, the patients actively perform the same exercises once a day for 20 min. The movements are based on a standardised post-surgical treatment protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- traumatic or non-traumatic (> 6 month) spinal cord injury
- Age ≥ 18 years
- Level of lesion C4 - Th1
- American Spinal Cord Injury Association Impairment Scale (AIS) A/B/C/D
- Planned reconstructive hand or arm surgery at the Swiss Paraplegic Centre Nottwil
Key exclusion criteria (3 listed)
- Patients during primary rehabilitation
- Patients' inability to follow the study, e.g. mental-health problems, language problems, dementia etc.
- Pregnancy (anamnestic)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Electrical StimulationFunctional electrical stimulation is applied with stimulators according to the lesion. In case of a upper motor neuron lesion the stimulation operates via nerve. For the stimulation surface electrodes are placed on the skin over the muscle belly. The stimulation of the innervated muscles will be conducted using the following conditions: 300-400 usec, 20-50 Hz, amplitude depends on the quality of muscle contraction (20-80 mA). the duty cycle of the stimulation is 3 sec. ramp up, 5 ec. plateau, 2 sec. ramp down, 10 sec. pause. | Device | Functional Electrical Stimulation |
Primary outcome
Change in evoked force
Time frame: 12 weeks before surgery, 1 day before surgery, 4 weeks post-surgery and 16 weeks post-surgery
Change in voluntary and electro-stimulated evoked force (torque Nm) for the recipient muscle
Change in power output
Time frame: 12 weeks before surgery, 1 day before surgery, 4 weeks post-surgery and 16 weeks post-surgery
Change in voluntary and electro-stimulated power output (W) for the recipient muscle
4 secondary outcomes
Change in Canadian Occupational Performance Measurement (COPM)
Time frame: 2 weeks before surgery, 1 day before surgery and 16 weeks post-surgery
Change in muscle volume
Time frame: 2 weeks before surgery, 1 day before surgery and 16 weeks post-surgery
Change in the treatment effectiveness
Time frame: 2 weeks before surgery, 1 day before surgery and 16 weeks post-surgery
Change in muscle activity
Time frame: 4 weeks post-surgery and 16 weeks post-surgery
Results and safety
The study was stopped early (reason given: Inability to recruit further study participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Fridén, Prof. Dr. med. principal investigator
Swiss Paraplegic Centre Nottwil, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Electrical Stimulation in people with Spinal Cord Injury Cervical, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inability to recruit further study participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in evoked force (time frame: 12 weeks before surgery, 1 day before surgery, 4 weeks post-surgery and 16 weeks post-surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.