The Effect of Functional Electrical Stimulation (FES) in Tetraplegia Reconstructive Surgery of the Upper Limbs - a Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Switzerland
Swiss Paraplegic Centre
RECRUITING
Nottwil
Contact Information
Primary
Ines Bersch, Dr (PhD)
ines.bersch@paraplegie.ch
+41 41 939 42 06
Backup
Kathrin Schafer, MPH
kathrin.schafer@paraplegie.ch
+41 41 939 43 34
Time Frame
Start Date: 2017-03-01
Estimated Completion Date: 2025-11
Participants
Target number of participants: 30
Treatments
Experimental: Functional Electrical Stimulation
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.
No_intervention: Standard therapy
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.
Related Therapeutic Areas
Sponsors
Leads: Swiss Paraplegic Research, Nottwil

This content was sourced from clinicaltrials.gov