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Chronic StrokeNCT05352009

The Application of Sling Exercise Training in People With Chronic Stroke

A study testing Sling exercise training and Conventional balance training in people with Chronic Stroke, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Chronic Stroke
What is being tested?
Sling exercise training and Conventional balance training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteTaiwan
Study dates
9 Aug 2022to 13 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • National Yang Ming Chiao Tung University

    Taipei, 112

Other trials in Taiwan

About this study

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

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.

Conditions
Chronic Stroke
Being tested
Sling exercise training, Conventional balance training
Keywords
Core control, Sling exercise training, Gait, Chronic stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sling exercise trainingOther

    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.

  • Conventional balance trainingOther

    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.

Study groups in NCT05352009
Study groupRoleWhat they receive
Sling exercise training groupExperimentalParticipants will practice core muscle exercise in different positions with sling systems (Redcord®, Norway).
Receives: Other: Sling exercise training
Conventional training groupActive comparatorParticipants 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.
Receives: Other: Conventional balance training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gait performance: change in gait speed

    Using GAITRite® system to evaluate gait speed in comfortable speed

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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 (10)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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

    Measured: 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.

    Measured: 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

    Measured: 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.

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2022
  2. Study start9 Aug 2022
  3. Primary completion13 Jun 2023
  4. Study completion13 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05352009
Sponsor's protocol ID
YM111016F
Status last verified
Nov 2023
First submitted
18 Apr 2022
Last updated
9 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Sling exercise training and Conventional balance training in people with Chronic Stroke, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05352009.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.

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