The Application of Sling Exercise Training in People With Chronic Stroke

NCT05352009 | Completed

• 1 other identifier: YM111016F
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Stroke

Keywords

Core control; Sling exercise training; Gait; Chronic stroke

Outcome Measures

Primary Outcomes (4)

• Gait performance: change in gait speed

  Using GAITRite® system to evaluate gait speed in comfortable speed

  Change from baseline gait speed at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up)

• Gait performance: change in stride length

  Using GAITRite® system to evaluate stride length in comfortable speed

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

• Gait performance: change in single leg support time

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

  Change from baseline single leg support time at 4 weeks and at 4 weeks after the intervention period (pre-, post-test and follow-up)

• Gait performance: change in temporal and spatial symmetry index

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

  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)

• Balance: change in movement velocity

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

• Balance: change in directional control

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

• Balance: change in maximal excursion

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

• Balance: change in one leg stance

  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)

• Balance: change in functional balance performance

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

Study Arms (2)

Sling exercise training group

EXPERIMENTAL

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

Other: Sling exercise training

Conventional training group

ACTIVE COMPARATOR

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

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.

Sling exercise training group

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.

Conventional training group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

National Yang Ming Chiao Tung University

Taipei, 112, Taiwan

Location

Study Officials

• Ray-Yau Wang, PhD

  National Yang Ming Chiao Tung University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 28, 2022
• Study Start: August 9, 2022
• Primary Completion: June 13, 2023
• Study Completion: June 13, 2023
• Last Updated: November 9, 2023

Record last verified: 2023-11

Locations

TW (1)