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Clinical Trials/NCT05352009
NCT05352009CompletedNot Applicable

The Application of Sling Exercise Training in People With Chronic Stroke - The Emphasis of Core Muscle Control on Gait

National Yang Ming Chiao Tung University1 site in 1 country19 target enrollmentStarted: August 9, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
19
Locations
1
Primary Endpoint
Gait performance: change in stride length

Study Overview

Brief Summary

The purpose of this single-blinded, randomized controlled study aims to investigate the effects of sling exercise training (SET) for core muscle on gait performance in people with chronic stroke.

Detailed Description

Background and purpose: Balance and gait performance are often impaired in people post stroke. Evidence showed positive correlations between trunk control and balance and walking ability. Previous studies applying core muscle training reported positive effects on improving trunk control and sitting balance among patients with chronic stroke, but benefits on standing balance and gait performance remain undetermined. Sling exercise training (SET) has been suggested for improving core muscle stability and strength in people with stroke. However, studies about effects of SET on gait performance in stroke populations are limited. Therefore, the present study aims to investigate the effects of SET for core muscle on gait performance in people with chronic stroke.

Methods: Thirty-eight individuals with chronic stroke will be recruited and assigned to one of the two groups by randomization, sling exercise training group and conventional training group. The training is 30 minutes per session, 3 sessions per week for total of 4 weeks. Gait performance is the primary outcome to include gait speed, stride length, single leg support time and temporal and spatial symmetry measured by GAITRite® System. Secondary outcomes include balance, timed up-and-go (TUG) test and trunk performance. All outcomes will be assessed before, after the 4-week training program and at 4-week follow-up.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Stroke after onset ≥ 6 months
  • •Trunk impairment scale (TIS) score ≤ 21 at baseline
  • •Brunnstrome stage ≥ IV over the affected lower extremity
  • •Ability to independently walk for 10 meters with or without assistive devices
  • •Intact cognition with mini-mental state examination (MMSE) ≥ 24

Exclusion Criteria

  • •Any other significant musculoskeletal disorder, neurological disease or cardiovascular disease that may affect the participation in this study.
  • •Vision or language deficit that may affect participating in this study.

Arms & Interventions

Sling exercise training group

Experimental

Participants will practice core muscle exercise in different positions with sling systems (Redcord®, Norway).

Intervention: Sling exercise training (Other)

Conventional training group

Active Comparator

Participants will practice balance exercise, including sit-to-stand, forward reaching, postural training on the therapeutic ball, maintaining standing balance with eyes open and progress to eyes close, and tandem stance.

Intervention: Conventional balance training (Other)

Outcomes

Primary Outcomes

Gait performance: change in stride length

Time Frame: Change from baseline stride length at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up)

Using GAITRite® system to evaluate stride length in comfortable speed

Gait performance: change in single leg support time

Time Frame: Change from baseline single leg support time at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up)

Using GAITRite® system to evaluate single leg support time in comfortable speed

Gait performance: change in gait speed

Time Frame: Change from baseline gait speed at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up)

Using GAITRite® system to evaluate gait speed in comfortable speed

Gait performance: change in temporal and spatial symmetry index

Time Frame: Change from baseline temporal and spatial symmetry index at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up)

Using GAITRite® system to evaluate temporal and spatial symmetry index in comfortable speed

Secondary Outcomes

  • Balance: change in maximal excursion(Change from baseline maximal excursion at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up))
  • Change in mobility performance(Change from baseline mobility performance at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up))
  • Change in trunk control(Change from baseline TIS at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up))
  • Change in trunk muscle strength: trunk lateral flexors(Change from baseline strength of trunk lateral flexors at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up))
  • Change in trunk muscle strength: trunk flexors(Change from baseline strength of trunk flexors at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up))
  • Change in trunk muscle strength: trunk extensors(Change from baseline strength of trunk extensors at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up))
  • Balance: change in directional control(Change from baseline directional control at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up))
  • Balance: change in one leg stance(Change from baseline postural sway under one leg stance at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up))
  • Balance: change in functional balance performance(Change from baseline BBS at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up))
  • Balance: change in movement velocity(Change from baseline movement velocity at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ray-Yau Wang

Professor

National Yang Ming Chiao Tung University

Study Sites (1)

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