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NCT02265042 Clinical Trial

Effect of Electrostimulation on Denervated Muscles in Individuals With Spinal Cord Injury

Spinal Cord Injury Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02265042
Other study ID # 2012-13
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 2012
Est. completion date December 2024

Study information
Verified date October 2023
Source Swiss Paraplegic Research, Nottwil
Contact Ines Bersch-Porada
Phone +41 41 939 4206
Email ines.bersch@paraplegie.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study is to investigate whether there is an effect of electrical stimulation on the denervated gluteus muscle (buttocks) in individuals with chronic spinal cord injury. The expected outcome is an increase in muscle volume and a better pressure distribution during sitting. The stimulation of the gluteus muscle is performed daily for 35 minutes over a period of six months. The muscle volume and the pressure distribution are measured before stimulation, three months after having started stimulation and after six months.

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date December 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - chronic spinal cord injury (min. 2 years after injury) - lesion height from T10-L5 - ASIA (American Spinal Cord Injury Association) Impairment Scale A Exclusion Criteria: - acute pressure sore in stimulated area (M. gluteus) - arteriosclerosis - skin irritation or infection in stimulated area (M. gluteus) - < 3 months after plastic surgery in stimulated area (M. gluteus)

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Stimulette
electrical stimulation device by Dr. Schuhfried Medizintechnik GmbH, Vienna, Austria

Locations
Country Name City State
Switzerland Swiss Paraplegic Centre Nottwil LU

Sponsors (1)
Lead Sponsor Collaborator
Swiss Paraplegic Research, Nottwil

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary change in muscle volume determination of muscle volume using magnetic resonance images day 0 to 3 months
Secondary change in muscle volume determination of muscle volume using magnetic resonance images 3 months to 6 months
Secondary change in sitting pressure pressure mapping system day 0 to 3 months
Secondary change in sitting pressure pressure mapping system 3 months to 6 months
Secondary change in quality of life questionnaire day 0 to 3months
Secondary change in quality of life questionnaire 3 months to 6 months
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