Strategy of Turning Performance in Individuals With Stroke

Not Applicable

Recruiting

• Conditions: Stroke
• Interventions: Other: Upper limb and trunk training; Other: Exergame-based balance training

• Registration Number: NCT06000904
• Lead Sponsor: National Yang Ming Chiao Tung University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-06
• Study First Submitted QC: 2023-08-13
• Study First Posted: 2023-08-21
• Study Start: 2023-10-19
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-26
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Upper limb and trunk training group	Upper limb and trunk training	-
Exergame-based balance training group	Exergame-based balance training	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.
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.
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.
Swing phase duration (%) in straight walk	Change from baseline at 4 weeks
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.
Step length (cm) in straight walk	Change from baseline at 4 weeks
Cadence (steps/minute) in straight walk	Change from baseline at 4 weeks
Walking velocity (cm/sec) in straight walk	Change from baseline at 4 weeks
Stance phase duration (%) in straight walk	Change from baseline at 4 weeks

Trial Locations

Locations (1)

Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University; 🇨🇳 Taipei, Taiwan