Strategy of Turning Performance in Individuals With Stroke

Sponsor
National Yang Ming University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06000904
Collaborator
(none)
30
1
2
16.4
1.8

Study Details

Study Description

Brief Summary

This is a single-blind randomized controlled trial study. Thirty individuals with chronic stroke will be recruited and randomly assigned to the experimental and control groups. Subjects in the experimental group will receive exergame-based balance training, while subjects in the control group will receive upper limb and trunk training. Both groups will undergo a four-week intervention consisting of three sessions per week, each lasting 60 minutes.

Condition or Disease Intervention/Treatment Phase
  • Other: Exergame-based balance training
  • Other: Upper limb and trunk training
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Evaluation and Improving Strategy of Turning Performance in Individuals With Stroke
Anticipated Study Start Date :
Aug 21, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Exergame-based balance training group

Other: Exergame-based balance training
For a four-week intervention consisting of three weekly sessions, each lasting 60 minutes. Each training session will include a 5-minute warm-up activity, 40-minute balance exercise, and 15-minute ground walking as a cool-down.

Active Comparator: Upper limb and trunk training group

Other: Upper limb and trunk training
For a four-week intervention consisting of three weekly sessions, each lasting 60 minutes. Each training session will include a 5-minute warm-up activity, 40-minute upper-limb and trunk exercise, and 15-minute ground walking as a cool-down.

Outcome Measures

Primary Outcome Measures

  1. Turning velocity (degrees/second) [Change from baseline at 4 weeks]

  2. Number of steps taken during turning [Change from baseline at 4 weeks]

  3. Turning step length (cm) [Change from baseline at 4 weeks]

  4. Stance phase duration (%) during turning [Change from baseline at 4 weeks]

  5. Swing phase duration (%) during turning [Change from baseline at 4 weeks]

Secondary Outcome Measures

  1. Berg Balance Scale [Change from baseline at 4 weeks]

    The Berg Balance Scale is employed to evaluate the functional balance ability of the subjects. This tool comprises 14 individual tests, each scored on a scale from 0 to 4, resulting in a total score of 56. A higher score indicates better balance ability.

  2. Limits of stability test [Change from baseline at 4 weeks]

    The limits of stability test is used to evaluate the dynamic balance ability of participants. Overall percentage is defined as the amount of direction control accuracy the individual has when performing the test. A higher percentage reflects better performance.

  3. Modified clinical test of sensory interaction in balance [Change from baseline at 4 weeks]

    This test is designed to assess sensory integration ability basing on the conditions of eyes open or closed and stable or unstable ground. The test is conducted in four contexts: context 1 involves standing with eyes open on a firm surface; context 2 involves standing with eyes open on a foam cushion; context 3 involves standing with eyes closed on a firm surface; and context 4 involves standing with eyes closed on a foam cushion. The overall sway index will be recorded for each condition of each trial, which will be summed the average of each condition.

  4. Walking velocity (cm/sec) in straight walk [Change from baseline at 4 weeks]

  5. Step length (cm) in straight walk [Change from baseline at 4 weeks]

  6. Cadence (steps/minute) in straight walk [Change from baseline at 4 weeks]

  7. Stance phase duration (%) in straight walk [Change from baseline at 4 weeks]

  8. Swing phase duration (%) in straight walk [Change from baseline at 4 weeks]

  9. Time Up and Go test [Change from baseline at 4 weeks]

    The Timed Up & Go (TUG) test is employed to evaluate the activity functionality of participants. The average time taken for completion will be recorded for analysis.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • aged ≥18 years

  • single incident of stroke

  • stroke duration of at least 6 months

  • lower limb Brunnstrom motor recovery stage between level three and five

  • Functional Ambulation Categories scale ≥3

Exclusion Criteria:
  • Individuals with cognitive impairmen (the Mini-Mental State Examination with a score below 24)

  • visual or auditory impairments

  • communication disorders

  • other neurological diseases affecting motor performance, or any orthopedic conditions that could influence walking ability

  • contraindications to physical activity, such as angina or uncontrolled hypertension

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University Taipei Taiwan 112

Sponsors and Collaborators

  • National Yang Ming University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yea-Ru Yang, Professor, National Yang Ming University
ClinicalTrials.gov Identifier:
NCT06000904
Other Study ID Numbers:
  • NYCU112118AF
First Posted:
Aug 21, 2023
Last Update Posted:
Aug 21, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yea-Ru Yang, Professor, National Yang Ming University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 21, 2023