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

Swiss Paraplegic Research, Nottwil

Status: Completed

Conditions: Spinal Cord Injury

Treatments: Device: Stimulette

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02265042

2012-13

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

electrical stimulation

Experimental group

Description:

electrical Stimulation using the Stimulette device

Treatment:

Device: Stimulette