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The Application of Sling Exercise Training in People With Chronic Stroke

Primary Purpose

Chronic Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Sling exercise training
Conventional balance training
Sponsored by
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Stroke focused on measuring Core control, Sling exercise training, Gait, Chronic stroke

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Yang Ming Chiao Tung UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sling exercise training group

Conventional training group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Gait performance: change in gait speed
Using GAITRite® system to evaluate gait speed in comfortable speed
Gait performance: change in stride length
Using GAITRite® system to evaluate stride length in comfortable speed
Gait performance: change in single leg support time
Using GAITRite® system to evaluate single leg support time in comfortable speed
Gait performance: change in temporal and spatial symmetry index
Using GAITRite® system to evaluate temporal and spatial symmetry index in comfortable speed

Secondary Outcome Measures

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.
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.
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.
Balance: change in one leg stance
Using Balance Master® to measure the sway under one leg standing
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.
Change in mobility performance
Using Timed up-and-go (TUG) test to assess mobility
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.
Change in trunk muscle strength: trunk flexors
Using hand held dynamometer (Power Tract II) to measure muscle strength of trunk flexors
Change in trunk muscle strength: trunk extensors
Using hand held dynamometer (Power Tract II) to measure muscle strength of trunk extensors
Change in trunk muscle strength: trunk lateral flexors
Using hand held dynamometer (Power Tract II) to measure muscle strength of trunk lateral flexors

Full Information

First Posted
April 18, 2022
Last Updated
September 26, 2022
Sponsor
National Yang Ming University
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1. Study Identification

Unique Protocol Identification Number
NCT05352009
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 9, 2022 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Yang Ming University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stroke
Keywords
Core control, Sling exercise training, Gait, Chronic stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sling exercise training group
Arm Type
Experimental
Arm Description
Participants will practice core muscle exercise in different positions with sling systems (Redcord®, Norway).
Arm Title
Conventional training group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Sling exercise training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional balance training
Intervention Description
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 Outcome Measure Information:
Title
Gait performance: change in gait speed
Description
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)
Title
Gait performance: change in stride length
Description
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)
Title
Gait performance: change in single leg support time
Description
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)
Title
Gait performance: change in temporal and spatial symmetry index
Description
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 Outcome Measure Information:
Title
Balance: change in movement velocity
Description
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)
Title
Balance: change in directional control
Description
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)
Title
Balance: change in maximal excursion
Description
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)
Title
Balance: change in one leg stance
Description
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)
Title
Balance: change in functional balance performance
Description
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)
Title
Change in mobility performance
Description
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)
Title
Change in trunk control
Description
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)
Title
Change in trunk muscle strength: trunk flexors
Description
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)
Title
Change in trunk muscle strength: trunk extensors
Description
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)
Title
Change in trunk muscle strength: trunk lateral flexors
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ray-Yau Wang, PhD
Phone
+886-2-2826-7210
Email
rywang@nycu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ray-Yau Wang, PhD
Organizational Affiliation
National Yang Ming Chiao Tung University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Yang Ming Chiao Tung University
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ray-Yau Wang, PhD
Phone
+886-2-28267210
Email
rywang@nycu.edu.tw

12. IPD Sharing Statement

Learn more about this trial

The Application of Sling Exercise Training in People With Chronic Stroke

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