Strategy of Turning Performance in Individuals With Stroke

August 13, 2023 updated by: Yea-Ru Yang, National Yang Ming University

Evaluation and Improving Strategy of Turning Performance in Individuals With Stroke

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 112
        • Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Turning velocity (degrees/second)
Time Frame: Change from baseline at 4 weeks
Change from baseline at 4 weeks
Number of steps taken during turning
Time Frame: Change from baseline at 4 weeks
Change from baseline at 4 weeks
Turning step length (cm)
Time Frame: Change from baseline at 4 weeks
Change from baseline at 4 weeks
Stance phase duration (%) during turning
Time Frame: Change from baseline at 4 weeks
Change from baseline at 4 weeks
Swing phase duration (%) during turning
Time Frame: Change from baseline at 4 weeks
Change from baseline at 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Berg Balance Scale
Time Frame: 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.
Change from baseline at 4 weeks
Limits of stability test
Time Frame: 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.
Change from baseline at 4 weeks
Modified clinical test of sensory interaction in balance
Time Frame: 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.
Change from baseline at 4 weeks
Walking velocity (cm/sec) in straight walk
Time Frame: Change from baseline at 4 weeks
Change from baseline at 4 weeks
Step length (cm) in straight walk
Time Frame: Change from baseline at 4 weeks
Change from baseline at 4 weeks
Cadence (steps/minute) in straight walk
Time Frame: Change from baseline at 4 weeks
Change from baseline at 4 weeks
Stance phase duration (%) in straight walk
Time Frame: Change from baseline at 4 weeks
Change from baseline at 4 weeks
Swing phase duration (%) in straight walk
Time Frame: Change from baseline at 4 weeks
Change from baseline at 4 weeks
Time Up and Go test
Time Frame: 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.
Change from baseline at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Yang Ming University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 21, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

August 6, 2023

First Submitted That Met QC Criteria

August 13, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 13, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NYCU112118AF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Exergame-based balance training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe