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

NCT ID: NCT03517787

Last Updated: 2023-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-03

Study Completion Date

2020-12-31

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.

Detailed Description

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Conditions

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Spinal Cord Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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FES+TE

Participants receiving Functional electrical stimulation (FES) combined with therapeutic exercise (TE)

Group Type EXPERIMENTAL

FES+TE

Intervention Type 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

Participants receiving only therapeutic exercise

Group Type ACTIVE_COMPARATOR

TE

Intervention Type OTHER

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

REF-FES+TE

Healthy adults (reference group REF) that participate only in 1 session and receive FES and therapeutic exercise

Group Type OTHER

REF-FES+TE

Intervention Type OTHER

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

REF-TE

Healthy adults that participate only in 1 session and receive only therapeutic exercise

Group Type OTHER

REF-TE

Intervention Type OTHER

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

Interventions

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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).

Intervention Type OTHER

TE

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

Intervention Type OTHER

REF-FES+TE

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

Intervention Type OTHER

REF-TE

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Tartu

OTHER

Sponsor Role collaborator

Tartu University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Margot Bergmann

Junior research fellow of Physical Therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Doris Vahtrik

Role: PRINCIPAL_INVESTIGATOR

University of Tartu

Locations

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University of Tartu

Tartu, , Estonia

Site Status

Countries

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Estonia

Other Identifiers

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Spinaal

Identifier Type: -

Identifier Source: org_study_id