The Application of Sling Exercise Training in People With Chronic Stroke

Sponsor
National Yang Ming University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05352009
Collaborator
(none)
38
1
2
14
2.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Sling exercise training
  • Other: Conventional balance training
N/A

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
Anticipated Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Application of Sling Exercise Training in People With Chronic Stroke - The Emphasis of Core Muscle Control on Gait
Anticipated Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sling exercise training group

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

Other: Sling exercise training
All participants will receive exercise training for 30 min/ session, 3 sessions/ week for 4 weeks (a total of 12 training sessions). The training includes 20 min of sling exercise training and 10 min treadmill training.

Active Comparator: Conventional training group

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.

Other: Conventional balance training
All participants will receive exercise training for 30 min/ session, 3 sessions/ week for 4 weeks (a total of 12 training sessions). The training includes 20 min of balance exercise training and 10 min treadmill training.

Outcome Measures

Primary Outcome Measures

  1. Gait performance: change in gait speed [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

  2. Gait performance: change in stride length [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

  3. Gait performance: change in single leg support time [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

  4. Gait performance: change in temporal and spatial symmetry index [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 Outcome Measures

  1. 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)]

    Using Balance Master®: Limits of Stability test to assess movement velocity during moving center of pressure to the highlighted target.

  2. 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)]

    Using Balance Master®: Limits of Stability test to assess directional control during moving center of pressure to the highlighted target.

  3. 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)]

    Using Balance Master®: Limits of Stability test to assess maximal excursion during moving center of pressure to the highlighted target.

  4. 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)]

    Using Balance Master® to measure the sway under one leg standing

  5. 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)]

    Using Berg Balance Scale (BBS) to assess functional balance performance. Berg Balance Scale is a 14-item scale which scoring 0-4 of each, ranges from 0 to 56, and higher score indicates better balance performance.

  6. 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)]

    Using Timed up-and-go (TUG) test to assess mobility

  7. 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)]

    Using Trunk Impairment Scale (TIS) to assess ability of trunk control. The trunk impairment scale ranges from 0 to 23, and a higher scoring indicates a better trunk control.

  8. 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)]

    Using hand held dynamometer (Power Tract II) to measure muscle strength of trunk flexors

  9. 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)]

    Using hand held dynamometer (Power Tract II) to measure muscle strength of trunk extensors

  10. 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)]

    Using hand held dynamometer (Power Tract II) to measure muscle strength of trunk lateral flexors

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Yang Ming Chiao Tung University Taipei Taiwan 112

Sponsors and Collaborators

  • National Yang Ming University

Investigators

  • Principal Investigator: Ray-Yau Wang, PhD, National Yang Ming Chiao Tung University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ray-Yau Wang, Professor, National Yang Ming University
ClinicalTrials.gov Identifier:
NCT05352009
Other Study ID Numbers:
  • YM111016F
First Posted:
Apr 28, 2022
Last Update Posted:
Apr 28, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ray-Yau Wang, Professor, National Yang Ming University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 28, 2022