Improving hand and arm function in tetraplegic patients using electrical stimulation and surgery
The Effect of Functional Electrical Stimulation (FES) in Tetraplegia Reconstructive Surgery of the Upper Limbs - a Pilot Study
This study is testing if using electrical stimulation along with surgery can help improve hand and arm function in people with tetraplegia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Swiss Paraplegic Research, Nottwil Research network |
| Locations | 1 site (Nottwil, Luzern) |
| Trial ID | NCT03048331 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of Functional Electrical Stimulation (FES) in combination with reconstructive hand and arm surgery for patients with tetraplegia. It aims to evaluate whether systematic training with FES before and after surgery can enhance muscle strength and functionality. A total of 30 participants will be randomized into two groups: one receiving standard therapy and the other receiving FES along with standard therapy. The study is conducted at the Swiss Paraplegic Centre, focusing on improving rehabilitation outcomes for individuals with spinal cord injuries.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a spinal cord injury at the C4 to Th1 level who are scheduled for reconstructive hand or arm surgery.
Not a fit: Patients who are in primary rehabilitation or have mental health issues that prevent them from following the study protocol may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the recovery of hand and arm function in tetraplegic patients.
How similar studies have performed: While FES has been established for lower limb rehabilitation, this study explores its novel application in conjunction with upper extremity reconstructive surgery, which has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Patients during primary rehabilitation * Patients' inability to follow the study, e.g. mental-health problems, language problems, dementia etc. * Pregnancy (anamnestic)
Where this trial is running
Nottwil, Luzern
- Swiss Paraplegic Centre — Nottwil, Luzern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Jan Fridén, Prof. Dr. med. — Swiss Paraplegic Centre Nottwil, Switzerland
- Study coordinator: Ines Bersch, Dr (PhD)
- Email: ines.bersch@paraplegie.ch
- Phone: +41 41 939 42 06
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.