Functional Electrical Stimulation (FES) and Reconstructive Tetraplegia Hand and Arm Surgery

NCT03048331 | Terminated

• 1 other identifier: 2015-06
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injury Cervical

Keywords

Functional Electrical Stimulation; Tetraplegia; Reconstructive Hand Surgery

Outcome Measures

Primary Outcomes (2)

• Change in evoked force

  Change in voluntary and electro-stimulated evoked force (torque Nm) for the recipient muscle

  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

  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)

  2 weeks before surgery, 1 day before surgery and 16 weeks post-surgery

• Change in muscle volume

  2 weeks before surgery, 1 day before surgery and 16 weeks post-surgery

• Change in the treatment effectiveness

  2 weeks before surgery, 1 day before surgery and 16 weeks post-surgery

• Change in muscle activity

  4 weeks post-surgery and 16 weeks post-surgery

Study Arms (2)

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.

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.

Interventions

Functional Electrical Stimulation DEVICE

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.

Functional Electrical Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients during primary rehabilitation
• Patients' inability to follow the study, e.g. mental-health problems, language problems, dementia etc.
• Pregnancy (anamnestic)

Sponsors & Collaborators

• Swiss Paraplegic Research, Nottwil: lead

Study Sites (1)

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

MeSH Terms

Conditions

Quadriplegia

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jan Fridén, Prof. Dr. med.

  Swiss Paraplegic Centre Nottwil, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2017
• First Posted: February 9, 2017
• Study Start: March 1, 2017
• Primary Completion: November 19, 2025
• Study Completion: November 19, 2025
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)