Clinical trial NCT05352009: The Application of Sling Exercise Training in People With Chronic Stroke
Official title: The Application of Sling Exercise Training in People With Chronic Stroke - The Emphasis of Core Muscle Control on Gait
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Stroke
Keywords: Core control
Sling exercise training
Gait
Chronic stroke
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 19
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Gait performance: change in gait speed
timeFrame: Change from baseline gait speed at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up)
measure: Gait performance: change in stride length
timeFrame: Change from baseline stride length at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up)
measure: Gait performance: change in single leg support time
timeFrame: Change from baseline single leg support time at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up)
measure: Gait performance: change in temporal and spatial symmetry index
timeFrame: 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:
measure: Balance: change in movement velocity
timeFrame: Change from baseline movement velocity at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up)
measure: Balance: change in directional control
timeFrame: Change from baseline directional control at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up)
measure: Balance: change in maximal excursion
timeFrame: Change from baseline maximal excursion at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up)
measure: Balance: change in one leg stance
timeFrame: 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)
measure: Balance: change in functional balance performance
timeFrame: Change from baseline BBS at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up)
measure: Change in mobility performance
timeFrame: Change from baseline mobility performance at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up)
measure: Change in trunk control
timeFrame: Change from baseline TIS at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up)
measure: Change in trunk muscle strength: trunk flexors
timeFrame: Change from baseline strength of trunk flexors at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up)
measure: Change in trunk muscle strength: trunk extensors
timeFrame: Change from baseline strength of trunk extensors at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up)
measure: Change in trunk muscle strength: trunk lateral flexors
timeFrame: 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)
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Yang Ming Chiao Tung University
Study officials:
affiliation: National Yang Ming Chiao Tung University
name: Ray-Yau Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References: