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

NCT03517787 | Completed

• 1 other identifier: Spinaal
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change of muscle tone

  Change from baseline measure at 6 weeks

Other Outcomes (2)

• Change of sitting balance

  Change from baseline measure at 6 weeks

• Health Related Quality of life

  Change from baseline measure at 6 weeks

Study Arms (4)

FES+TE

EXPERIMENTAL

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

Other: FES+TE

TE

ACTIVE COMPARATOR

Participants receiving only therapeutic exercise

Other: TE

REF-FES+TE

OTHER

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

Other: REF-FES+TE

REF-TE

OTHER

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

Other: REF-TE

Interventions

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).

FES+TE

TE OTHER

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

TE

REF-FES+TE OTHER

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

REF-FES+TE

REF-TE OTHER

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

REF-TE

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Tartu University Hospital: lead
• University of Tartu: collaborator

Study Sites (1)

University of Tartu

Tartu, Estonia

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• Doris Vahtrik

  University of Tartu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior research fellow of Physical Therapy

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: May 7, 2018
• Study Start: March 3, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2020
• Last Updated: December 14, 2023

Record last verified: 2023-12

Locations

ES (1)