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Completed

NCT Number: NCT02265042

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

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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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, 6207, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Stimulette

Device

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

Primary outcomes

  1. change in muscle volume

    Time frame: day 0 to 3 months

    determination of muscle volume using magnetic resonance images

Secondary outcomes

  1. change in muscle volume

    Time frame: 3 months to 6 months

    determination of muscle volume using magnetic resonance images

  2. change in sitting pressure

    Time frame: day 0 to 3 months

    pressure mapping system

  3. change in sitting pressure

    Time frame: 3 months to 6 months

    pressure mapping system

  4. change in quality of life

    Time frame: day 0 to 3months

    questionnaire

  5. change in quality of life

    Time frame: 3 months to 6 months

    questionnaire

Sponsors and collaborators

Lead sponsor

Swiss Paraplegic Research, Nottwil

Network

Registry information

Important dates

Study start
2012
Primary completion
2025
Study completion
2025
First posted
Oct 15, 2014
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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