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CompletedNCT05352009Updated Nov 9, 2023

The Application of Sling Exercise Training in People With Chronic Stroke

An interventional study of Sling exercise training and Conventional balance training in Chronic Stroke, sponsored by National Yang Ming Chiao Tung University. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-11-09.

Sponsored by National Yang Ming Chiao Tung University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chronic Stroke

Keywords

  • Core control
  • Sling exercise training
  • Gait
  • Chronic stroke
03

In context

Lead sponsor

National Yang Ming Chiao Tung University is the lead sponsor of 204 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    Sling exercise training group

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

    Other: Sling exercise 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

Interventions

  • OtherSling 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.

  • OtherConventional 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.

06

What researchers measure

Primary outcomes

  1. Gait performance: change in gait speed

    Using GAITRite® system to evaluate gait speed in comfortable 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)

  2. Gait performance: change in stride length

    Using GAITRite® system to evaluate stride length in comfortable speed

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

  3. Gait performance: change in single leg support time

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

    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)

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

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

    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)

Secondary outcomes

  1. Balance: change in movement velocity

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

    Time frame: Change from baseline movement velocity at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up)

  2. Balance: change in directional control

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

    Time frame: Change from baseline directional control at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up)

  3. Balance: change in maximal excursion

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

    Time frame: Change from baseline maximal excursion at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up)

  4. Balance: change in one leg stance

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

    Time frame: 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)

  5. Balance: change in functional balance performance

    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.

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

  6. Change in mobility performance

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

    Time frame: Change from baseline mobility performance at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up)

  7. Change in trunk control

    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.

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

  8. Change in trunk muscle strength: trunk flexors

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

    Time frame: Change from baseline strength of trunk flexors at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up)

  9. Change in trunk muscle strength: trunk extensors

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

    Time frame: Change from baseline strength of trunk extensors at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up)

  10. Change in trunk muscle strength: trunk lateral flexors

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

    Time frame: 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)

07

Study locations

1 site
  • National Yang Ming Chiao Tung University
    Taipei, 112, Taiwan
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2022 to primary completion in Jun 2023, 10 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 18, 2022
First posted
Apr 28, 2022
StartActual
Aug 9, 2022
Primary completionActual
Jun 13, 2023
CompletionActual
Jun 13, 2023
Last update
Nov 9, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05352009
Responsible party
Ray-Yau Wang (Professor, National Yang Ming Chiao Tung University) — Principal investigator
First posted
Apr 28, 2022
Start date
Aug 9, 2022
Primary completion
Jun 13, 2023
Completion
Jun 13, 2023
Last update
Nov 9, 2023

Study contacts

Ray-Yau Wang, PhD
principal investigator · National Yang Ming Chiao Tung University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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