Electrical Stimulation of Denervated Muscles After Spinal Cord Injury

Not Applicable

Terminated

• Conditions: Spinal Cord Injury
• Interventions: Device: Electrical Stimulation

• Registration Number: NCT02080039
• Lead Sponsor: Swiss Paraplegic Research, Nottwil

Brief Summary

In this study the following hypotheses will be tested:

Electrical stimulation of the gluteal muscle (buttocks) leads to

1. an increase in the thickness of the gluteal muscle

2. a decrease in the thickness of the fat of the buttock area

3. a change in the distribution of the middle and maximal seating pressure to a more consistent pressure

4. an increase in well-being of the patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2014-02-24
• Study First Submitted QC: 2014-03-04
• Study First Posted: 2014-03-06
• Status Verified: 2014-11
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Last Update Submitted: 2014-11-19
• Last Update Posted: 2014-11-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Electrical Stimulation	Electrical Stimulation	-

Primary Outcome Measures

Name	Time	Method
Magnetic Resonance Imaging to determine the thickness of the gluteal muscle and fat tissue of the buttock.	45 min.

Secondary Outcome Measures

Name	Time	Method
Measuring of the seating pressure to determine the distribution of the middle and maximal seating pressure	15 min.
Questionnaire on subjective wellbeing	10 min.	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.

Trial Locations

Locations (1)

Swiss Paraplegic Centre; 🇨🇭 Nottwil, LU, Switzerland