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Completed

NCT Number: NCT03517787

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

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.

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Tartu

Tartu, Estonia

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

FES+TE

Other

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

Other

Group perform only therapeutic exercise. Exercises are the same between all 4 groups.

REF-FES+TE

Other

Group perform FES+TE, but only participate in 1 session to collect reference data.

REF-TE

Other

Group perform only therapeutic exercise, but only participate in 1 session to collect reference data.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Tartu University Hospital

Other

Collaborators

  • University of Tartu

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2020
First posted
May 7, 2018
Registry last updated
Dec 14, 2023

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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