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

Primary Purpose

Spinal Cord Injury

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Stimulette
Sponsored by
Swiss Paraplegic Research, Nottwil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Swiss Paraplegic CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

electrical stimulation

Arm Description

electrical Stimulation using the Stimulette device

Outcomes

Primary Outcome Measures

change in muscle volume
determination of muscle volume using magnetic resonance images

Secondary Outcome Measures

change in muscle volume
determination of muscle volume using magnetic resonance images
change in sitting pressure
pressure mapping system
change in sitting pressure
pressure mapping system
change in quality of life
questionnaire
change in quality of life
questionnaire

Full Information

First Posted
October 7, 2014
Last Updated
October 20, 2023
Sponsor
Swiss Paraplegic Research, Nottwil
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1. Study Identification

Unique Protocol Identification Number
NCT02265042
Brief Title
Effect of Electrostimulation on Denervated Muscles in Individuals With Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 2012 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Paraplegic Research, Nottwil

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
electrical stimulation
Arm Type
Experimental
Arm Description
electrical Stimulation using the Stimulette device
Intervention Type
Device
Intervention Name(s)
Stimulette
Intervention Description
electrical stimulation device by Dr. Schuhfried Medizintechnik GmbH, Vienna, Austria
Primary Outcome Measure Information:
Title
change in muscle volume
Description
determination of muscle volume using magnetic resonance images
Time Frame
day 0 to 3 months
Secondary Outcome Measure Information:
Title
change in muscle volume
Description
determination of muscle volume using magnetic resonance images
Time Frame
3 months to 6 months
Title
change in sitting pressure
Description
pressure mapping system
Time Frame
day 0 to 3 months
Title
change in sitting pressure
Description
pressure mapping system
Time Frame
3 months to 6 months
Title
change in quality of life
Description
questionnaire
Time Frame
day 0 to 3months
Title
change in quality of life
Description
questionnaire
Time Frame
3 months to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ines Bersch-Porada
Phone
+41 41 939 4206
Email
ines.bersch@paraplegie.ch
Facility Information:
Facility Name
Swiss Paraplegic Centre
City
Nottwil
State/Province
LU
ZIP/Postal Code
6207
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ines Bersch-Porada
Phone
+41 41 939 42 06
Email
ines.bersch@paraplegie.ch

12. IPD Sharing Statement

Learn more about this trial

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

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