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Electrical Stimulation of Denervated Muscles After Spinal Cord Injury

Primary Purpose

Spinal Cord Injury

Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
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 focused on measuring Spinal Cord Injury, Denervation, Electrical Stimulation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Duration of palsy: minimum two years after traumatic or non-traumatic spinal cord injury
  • Level of lesion: T 10 to L 5, AIS A, classified by the American Spinal Injury Association (AISA)

Exclusion Criteria:

  • Acute decubitus in the stimulated area
  • Arteriosclerosis
  • Less than three months after flap surgery or after decubitus in the stimulated area
  • Infections or skin eczema in the stimulated area

Sites / Locations

  • Swiss Paraplegic Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Electrical Stimulation

Arm Description

Outcomes

Primary Outcome Measures

Magnetic Resonance Imaging to determine the thickness of the gluteal muscle and fat tissue of the buttock.

Secondary Outcome Measures

Measuring of the seating pressure to determine the distribution of the middle and maximal seating pressure
Questionnaire on subjective wellbeing
The subjective effect of the electric stimulation will be assessed by an 5-item-questionnaire. Since no standardised questionnaire is available to assess the well-being in relation to sitting in a wheelchair, an individual non-validated questionnaire has been developed. It contains five questions: Question 1 and 2 address the number of resting phases while lying down and the respective overall duration of decompression each day. The questions 3 to 5 focus on the fear of pressure sores while sitting, every day limitations based on decompression phases and the subjective well-being while sitting in a wheelchair. The subjects answer the questions using a visual analog scale of 10 cm, indicating 0=no fear/no impairment/no well-being; 10=high fear/high impairment/high well-being. The subjects complete the questionnaire at baseline (start of intervention), after three and after six months.

Full Information

First Posted
February 24, 2014
Last Updated
November 19, 2014
Sponsor
Swiss Paraplegic Research, Nottwil
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1. Study Identification

Unique Protocol Identification Number
NCT02080039
Brief Title
Electrical Stimulation of Denervated Muscles After Spinal Cord Injury
Official Title
Clinical Pilot Study of the Effect of Electrical Stimulation of Denervated Muscles After Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Terminated
Study Start Date
September 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In this study the following hypotheses will be tested: Electrical stimulation of the gluteal muscle (buttocks) leads to an increase in the thickness of the gluteal muscle a decrease in the thickness of the fat of the buttock area a change in the distribution of the middle and maximal seating pressure to a more consistent pressure an increase in well-being of the patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
Spinal Cord Injury, Denervation, Electrical Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electrical Stimulation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Electrical Stimulation
Primary Outcome Measure Information:
Title
Magnetic Resonance Imaging to determine the thickness of the gluteal muscle and fat tissue of the buttock.
Time Frame
45 min.
Secondary Outcome Measure Information:
Title
Measuring of the seating pressure to determine the distribution of the middle and maximal seating pressure
Time Frame
15 min.
Title
Questionnaire on subjective wellbeing
Description
The subjective effect of the electric stimulation will be assessed by an 5-item-questionnaire. Since no standardised questionnaire is available to assess the well-being in relation to sitting in a wheelchair, an individual non-validated questionnaire has been developed. It contains five questions: Question 1 and 2 address the number of resting phases while lying down and the respective overall duration of decompression each day. The questions 3 to 5 focus on the fear of pressure sores while sitting, every day limitations based on decompression phases and the subjective well-being while sitting in a wheelchair. The subjects answer the questions using a visual analog scale of 10 cm, indicating 0=no fear/no impairment/no well-being; 10=high fear/high impairment/high well-being. The subjects complete the questionnaire at baseline (start of intervention), after three and after six months.
Time Frame
10 min.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Duration of palsy: minimum two years after traumatic or non-traumatic spinal cord injury Level of lesion: T 10 to L 5, AIS A, classified by the American Spinal Injury Association (AISA) Exclusion Criteria: Acute decubitus in the stimulated area Arteriosclerosis Less than three months after flap surgery or after decubitus in the stimulated area Infections or skin eczema in the stimulated area
Facility Information:
Facility Name
Swiss Paraplegic Centre
City
Nottwil
State/Province
LU
ZIP/Postal Code
6207
Country
Switzerland

12. IPD Sharing Statement

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Electrical Stimulation of Denervated Muscles After Spinal Cord Injury

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