Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03048331 |
| Other study ID # |
2015-06 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2017 |
| Est. completion date |
December 2024 |
Study information
| Verified date |
October 2023 |
| Source |
Swiss Paraplegic Research, Nottwil |
| Contact |
Ines Bersch, MSc |
| Phone |
+41 41 9394206 |
| Email |
ines.bersch[@]paraplegie.ch |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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.
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.
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