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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03517787
Enrollment
5
Registered
2018-05-07
Start date
2017-03-03
Completion date
2020-12-31
Last updated
2023-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injuries

Brief 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.

Interventions

OTHERFES+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).

OTHERTE

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

OTHERREF-FES+TE

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

OTHERREF-TE

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

Sponsors

University of Tartu
CollaboratorOTHER
Tartu University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change of median power frequency (MPF) and amplitude (A)Change from baseline measure at 6 weeksChange 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

MeasureTime frameDescription
Change of muscle toneChange from baseline measure at 6 weeksMuscle 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

MeasureTime frameDescription
Change of sitting balanceChange from baseline measure at 6 weeksSitting 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.
Health Related Quality of lifeChange from baseline measure at 6 weeksRAND-36 questionnaire is used to measure health-related quality of life

Countries

Estonia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026