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

Spinal Cord Injury Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02265042
• Other study ID #: 2012-13
• Status: Recruiting
• Phase: N/A
• Start date: January 2012
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Swiss Paraplegic Research, Nottwil
• Contact: Ines Bersch-Porada
• Phone: +41 41 939 4206
• Email: ines.bersch[@]paraplegie.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Device:
• Stimulette
electrical stimulation device by Dr. Schuhfried Medizintechnik GmbH, Vienna, Austria

Locations

Country	Name	City	State
Switzerland	Swiss Paraplegic Centre	Nottwil	LU

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Paraplegic Research, Nottwil

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in muscle volume	determination of muscle volume using magnetic resonance images	day 0 to 3 months
Secondary	change in muscle volume	determination of muscle volume using magnetic resonance images	3 months to 6 months
Secondary	change in sitting pressure	pressure mapping system	day 0 to 3 months
Secondary	change in sitting pressure	pressure mapping system	3 months to 6 months
Secondary	change in quality of life	questionnaire	day 0 to 3months
Secondary	change in quality of life	questionnaire	3 months to 6 months