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

Primary Purpose

Spinal Cord Injury Cervical

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Functional Electrical Stimulation
Sponsored by
Swiss Paraplegic Research, Nottwil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury Cervical focused on measuring Functional Electrical Stimulation, Tetraplegia, Reconstructive Hand Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Swiss Paraplegic CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Functional Electrical Stimulation

Standard therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Canadian Occupational Performance Measurement (COPM)
Changes of functional outcomes (i.e. performance and satisfaction) of the treated upper limb before and after surgery
Change in muscle volume
Difference in muscle volume of the treated limb before and after surgery measured by ultrasound
Change in the treatment effectiveness
Questionnaire of the participant's perception of the treatment effectiveness to evaluate the benefit of FES according to effort of the treatment
Change in muscle activity
Change in the muscle activity of a transferred muscle in a new function surface assessed by EMG

Full Information

First Posted
February 7, 2017
Last Updated
October 20, 2023
Sponsor
Swiss Paraplegic Research, Nottwil
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1. Study Identification

Unique Protocol Identification Number
NCT03048331
Brief Title
Functional Electrical Stimulation (FES) and Reconstructive Tetraplegia Hand and Arm Surgery
Acronym
FES
Official Title
The Effect of Functional Electrical Stimulation (FES) in Tetraplegia Reconstructive Surgery of the Upper Limbs - A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Paraplegic Research, Nottwil

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury Cervical
Keywords
Functional Electrical Stimulation, Tetraplegia, Reconstructive Hand Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Functional Electrical Stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard therapy
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Functional Electrical Stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in evoked force
Description
Change in voluntary and electro-stimulated evoked force (torque Nm) for the recipient muscle
Time Frame
12 weeks before surgery, 1 day before surgery, 4 weeks post-surgery and 16 weeks post-surgery
Title
Change in power output
Description
Change in voluntary and electro-stimulated power output (W) for the recipient muscle
Time Frame
12 weeks before surgery, 1 day before surgery, 4 weeks post-surgery and 16 weeks post-surgery
Secondary Outcome Measure Information:
Title
Change in Canadian Occupational Performance Measurement (COPM)
Description
Changes of functional outcomes (i.e. performance and satisfaction) of the treated upper limb before and after surgery
Time Frame
2 weeks before surgery, 1 day before surgery and 16 weeks post-surgery
Title
Change in muscle volume
Description
Difference in muscle volume of the treated limb before and after surgery measured by ultrasound
Time Frame
2 weeks before surgery, 1 day before surgery and 16 weeks post-surgery
Title
Change in the treatment effectiveness
Description
Questionnaire of the participant's perception of the treatment effectiveness to evaluate the benefit of FES according to effort of the treatment
Time Frame
2 weeks before surgery, 1 day before surgery and 16 weeks post-surgery
Title
Change in muscle activity
Description
Change in the muscle activity of a transferred muscle in a new function surface assessed by EMG
Time Frame
4 weeks post-surgery and 16 weeks post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ines Bersch, MSc
Phone
+41 41 9394206
Email
ines.bersch@paraplegie.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Fridèn, Prof.med.
Organizational Affiliation
Swiss Paraplegic Centre Nottwil, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Swiss Paraplegic Centre
City
Nottwil
State/Province
Luzern
ZIP/Postal Code
6207
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Fridèn, Prof.med.
Phone
+41 41 939 5203
Email
jan.friden@paraplegie.ch
First Name & Middle Initial & Last Name & Degree
Ines Bersch, MSc
Phone
+41 41 939 4204
Email
ines.bersch@paraplegie.ch

12. IPD Sharing Statement

Plan to Share IPD
No

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

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