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NCT Number: NCT05352009

The Application of Sling Exercise Training in People With Chronic Stroke

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.

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Key information

Conditions

Chronic Stroke

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Yang Ming Chiao Tung University

Taipei, 112, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sling exercise training

Other

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 training

Other

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  1. Balance: change in movement velocity

    Time frame: 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

    Time frame: 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

    Time frame: 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

    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)

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

  5. Balance: change in functional 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)

    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

    Time frame: 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

    Time frame: 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

    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)

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

  9. Change in trunk muscle strength: 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)

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

  10. Change in trunk muscle strength: 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)

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

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 28, 2022
Registry last updated
Nov 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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