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Electrical Stimulation of Denervated Muscles After Spinal Cord Injury

NCT ID: NCT02080039

Last Updated: 2014-11-20

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

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-11-30

Brief Summary

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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.

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

Group Type EXPERIMENTAL

Electrical Stimulation

Intervention Type DEVICE

Interventions

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Electrical Stimulation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swiss Paraplegic Research, Nottwil

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2012-13

Identifier Type: -

Identifier Source: org_study_id