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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2025-01-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Spinal Cord Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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electrical stimulation

electrical Stimulation using the Stimulette device

Group Type EXPERIMENTAL

Stimulette

Intervention Type DEVICE

electrical stimulation device by Dr. Schuhfried Medizintechnik GmbH, Vienna, Austria

Interventions

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Stimulette

electrical stimulation device by Dr. Schuhfried Medizintechnik GmbH, Vienna, Austria

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No