The Effect of FES and Therapeutic Exercise on SCI Patients Skeletal Muscles, Sitting Balance, Posture and Quality of Life

Spinal Cord Injuries Clinical Trial

Official title:

The Effect of Functional Electrical Stimulation and Therapeutic Exercise on Functional Properties of Skeletal Muscles, Sitting Postural Stability and Quality of Life in Traumatic Spinal Cord Injury Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03517787
• Other study ID #: Spinaal
• Status: Completed
• Phase: N/A
• Start date: March 3, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: December 2023
• Source: Tartu University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aim of the current study is to evaluate the effect functional electrical stimulation and therapeutic exercise on traumatic spinal cord injured participants'skeletal muscle characteristics, sitting balance, lung function and quality of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Chronic spinal cord injury (12 months post injury) Injury in cervical region resulting in tetraparesis Able to sit on a custom made chair without support Does not have any contraindications for functional electrical stimulation

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

Other:
• FES+TE
Group receive FES+therapeutic exercise during 6 weeks (twice a week). Altogether 8 exercises are conducted, each done 3 sets and 12 repetitions during first three weeks and 4 sets during last three weeks of intervention).
• TE
Group perform only therapeutic exercise. Exercises are the same between all 4 groups.
• REF-FES+TE
Group perform FES+TE, but only participate in 1 session to collect reference data.
• REF-TE
Group perform only therapeutic exercise, but only participate in 1 session to collect reference data.

Locations

Country	Name	City	State
Estonia	University of Tartu	Tartu

Sponsors (2)

Lead Sponsor	Collaborator
Tartu University Hospital	University of Tartu

Country where clinical trial is conducted

Estonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of sitting balance	Sitting balance is measured using Tekscan Conformat pressure mat. Static sitting balance is measured at a custom made stool, hands are placed on participants thighs. For dynamic sitting balance, participants are asked to move their center of pressure to 4 different directions. Distance is measured.	Change from baseline measure at 6 weeks
Other	Health Related Quality of life	RAND-36 questionnaire is used to measure health-related quality of life	Change from baseline measure at 6 weeks
Primary	Change of median power frequency (MPF) and amplitude (A)	Change of MPF and A is measured after first therapy to assess the baseline values and then after 6 weeks of therapy to assess the effectiveness of intervention.	Change from baseline measure at 6 weeks
Secondary	Change of muscle tone	Muscle oscillation frequency (MOF) is measured to assess muscle tone. Change of MOF is measured after first therapy to assess the baseline values and then after 6 weeks of therapy to assess the effectiveness of intervention.	Change from baseline measure at 6 weeks