Strategy of Turning Performance in Individuals With Stroke

NCT ID: NCT06000904

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-19
• Study Completion Date: 2024-12-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Exergame-based balance training group

Group Type: EXPERIMENTAL

Exergame-based balance training

Intervention Type: OTHER

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.

Upper limb and trunk training group

Group Type: ACTIVE_COMPARATOR

Upper limb and trunk training

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Yang Ming Chiao Tung University

OTHER

Sponsor Role: lead

Responsible Party

Yea-Ru Yang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Facility Contacts

Yea-Ru Yang, PhD

Role: primary

yryang@nycu.edu.tw

+886-2-2826-7279

Other Identifiers

NYCU112118AF

Identifier Type: -

Identifier Source: org_study_id