NCT02265042

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 15, 2014

Completed
10.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2025

Completed
Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

13.1 years

First QC Date

October 7, 2014

Last Update Submit

November 19, 2025

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

  • change in muscle volume

    determination of muscle volume using magnetic resonance images

    day 0 to 3 months

Secondary Outcomes (5)

  • change in muscle volume

    3 months to 6 months

  • change in sitting pressure

    day 0 to 3 months

  • change in sitting pressure

    3 months to 6 months

  • change in quality of life

    day 0 to 3months

  • change in quality of life

    3 months to 6 months

Study Arms (1)

electrical stimulation

EXPERIMENTAL

electrical Stimulation using the Stimulette device

Device: Stimulette

Interventions

StimuletteDEVICE

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

electrical stimulation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic spinal cord injury (min. 2 years after injury)
  • lesion height from T10-L5
  • ASIA (American Spinal Cord Injury Association) Impairment Scale A

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD in Medical Sciences

Study Record Dates

First Submitted

October 7, 2014

First Posted

October 15, 2014

Study Start

January 1, 2012

Primary Completion

January 23, 2025

Study Completion

January 23, 2025

Last Updated

November 25, 2025

Record last verified: 2025-11

Locations

CH(1)