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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02080039
Other study ID # 2012-13
Secondary ID
Status Terminated
Phase N/A
First received February 24, 2014
Last updated November 19, 2014
Start date September 2012
Est. completion date November 2014

Study information

Verified date November 2014
Source Swiss Paraplegic Centre Nottwil
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 5
Est. completion date November 2014
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Electrical Stimulation


Locations

Country Name City State
Switzerland Swiss Paraplegic Centre Nottwil LU

Sponsors (1)

Lead Sponsor Collaborator
Swiss Paraplegic Centre Nottwil

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Magnetic Resonance Imaging to determine the thickness of the gluteal muscle and fat tissue of the buttock. 45 min. No
Secondary Measuring of the seating pressure to determine the distribution of the middle and maximal seating pressure 15 min. No
Secondary 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. 10 min. No
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