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

December 7, 2023 updated by: Margot Bergmann, Tartu University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Estonia
      • Tartu, Estonia
        • University of Tartu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FES+TE
Participants receiving Functional electrical stimulation (FES) combined with therapeutic exercise (TE)
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).
Active Comparator: TE
Participants receiving only therapeutic exercise
Other: TE
Group perform only therapeutic exercise. Exercises are the same between all 4 groups.
Other: REF-FES+TE
Healthy adults (reference group REF) that participate only in 1 session and receive FES and therapeutic exercise
Other: REF-FES+TE
Group perform FES+TE, but only participate in 1 session to collect reference data.
Other: REF-TE
Healthy adults that participate only in 1 session and receive only therapeutic exercise
Other: REF-TE
Group perform only therapeutic exercise, but only participate in 1 session to collect reference data.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of median power frequency (MPF) and amplitude (A)
Time Frame: Change from baseline measure at 6 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of muscle tone
Time Frame: Change from baseline measure at 6 weeks
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of sitting balance
Time Frame: Change from baseline measure at 6 weeks
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
Health Related Quality of life
Time Frame: Change from baseline measure at 6 weeks
RAND-36 questionnaire is used to measure health-related quality of life
Change from baseline measure at 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tartu University Hospital

Collaborators

University of Tartu

Investigators

  • Principal Investigator: Doris Vahtrik, University of Tartu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2017

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

April 10, 2018

First Submitted That Met QC Criteria

May 4, 2018

First Posted (Actual)

May 7, 2018

Study Record Updates

Last Update Posted (Estimated)

December 14, 2023

Last Update Submitted That Met QC Criteria

December 7, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Spinaal

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Spinal Cord Injuries

Clinical Trials on FES+TE

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe