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

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ClinicalTrials.gov Identifier: NCT03048331
Recruitment Status : Recruiting
First Posted : February 9, 2017
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Swiss Paraplegic Centre Nottwil

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.


Condition or disease Intervention/treatment Phase
Spinal Cord Injury Cervical Device: Functional Electrical Stimulation Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Functional Electrical Stimulation (FES) in Tetraplegia Reconstructive Surgery of the Upper Limbs - A Pilot Study
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

Device: Functional Electrical Stimulation

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.


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.



Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Change in Canadian Occupational Performance Measurement (COPM) [ Time Frame: 2 weeks before surgery, 1 day before surgery and 16 weeks post-surgery ]
    Changes of functional outcomes (i.e. performance and satisfaction) of the treated upper limb before and after surgery

  2. Change in muscle volume [ Time Frame: 2 weeks before surgery, 1 day before surgery and 16 weeks post-surgery ]
    Difference in muscle volume of the treated limb before and after surgery measured by ultrasound

  3. Change in the treatment effectiveness [ Time Frame: 2 weeks before surgery, 1 day before surgery and 16 weeks post-surgery ]
    Questionnaire of the participant's perception of the treatment effectiveness to evaluate the benefit of FES according to effort of the treatment

  4. Change in muscle activity [ Time Frame: 4 weeks post-surgery and 16 weeks post-surgery ]
    Change in the muscle activity of a transferred muscle in a new function surface assessed by EMG



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03048331


Contacts
Contact: Ines Bersch, MSc +41 41 9394206 ines.bersch@paraplegie.ch

Locations
Switzerland
Swiss Paraplegic Centre Recruiting
Nottwil, Luzern, Switzerland, 6207
Contact: Jan Fridèn, Prof.med.    +41 41 939 5203    jan.friden@paraplegie.ch   
Contact: Ines Bersch, MSc    +41 41 939 4204    ines.bersch@paraplegie.ch   
Sponsors and Collaborators
Swiss Paraplegic Centre Nottwil
Investigators
Principal Investigator: Jan Fridèn, Prof.med. Swiss Paraplegic Centre Nottwil, Switzerland

Responsible Party: Swiss Paraplegic Centre Nottwil
ClinicalTrials.gov Identifier: NCT03048331     History of Changes
Other Study ID Numbers: 2015-06
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Swiss Paraplegic Centre Nottwil:
Functional Electrical Stimulation
Tetraplegia
Reconstructive Hand Surgery

Additional relevant MeSH terms:
Spinal Cord Injuries
Quadriplegia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Paralysis
Neurologic Manifestations
Signs and Symptoms