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

Not Applicable

Recruiting

• Conditions: Spinal Cord Injury
• Interventions: Device: Stimulette

• Registration Number: NCT02265042
• Lead Sponsor: Swiss Paraplegic Research, Nottwil

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2014-10-07
• Study First Submitted QC: 2014-10-09
• Study First Posted: 2014-10-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-01
• Primary Completion: 2024-12-31
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
electrical stimulation	Stimulette	electrical Stimulation using the Stimulette device

Primary Outcome Measures

Name	Time	Method
change in muscle volume	day 0 to 3 months	determination of muscle volume using magnetic resonance images

Secondary Outcome Measures

Name	Time	Method
change in muscle volume	3 months to 6 months	determination of muscle volume using magnetic resonance images
change in sitting pressure	3 months to 6 months	pressure mapping system
change in quality of life	3 months to 6 months	questionnaire

Trial Locations

Locations (1)

Swiss Paraplegic Centre; 🇨🇭 Nottwil, LU, Switzerland