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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Other: FES+TE
* Other: TE
* Other: REF-FES+TE
* Other: REF-TE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |