Strategy of Turning Performance in Individuals With Stroke

Stroke Clinical Trial

Official title:

Evaluation and Improving Strategy of Turning Performance in Individuals With Stroke

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06000904
• Other study ID #: NYCU112118AF
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 21, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: National Yang Ming University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Turning velocity (degrees/second)		Change from baseline at 4 weeks
Primary	Number of steps taken during turning		Change from baseline at 4 weeks
Primary	Turning step length (cm)		Change from baseline at 4 weeks
Primary	Stance phase duration (%) during turning		Change from baseline at 4 weeks
Primary	Swing phase duration (%) during turning		Change from baseline at 4 weeks
Secondary	Berg Balance Scale	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
Secondary	Limits of stability test	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
Secondary	Modified clinical test of sensory interaction in balance	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
Secondary	Walking velocity (cm/sec) in straight walk		Change from baseline at 4 weeks
Secondary	Step length (cm) in straight walk		Change from baseline at 4 weeks
Secondary	Cadence (steps/minute) in straight walk		Change from baseline at 4 weeks
Secondary	Stance phase duration (%) in straight walk		Change from baseline at 4 weeks
Secondary	Swing phase duration (%) in straight walk		Change from baseline at 4 weeks
Secondary	Time Up and Go test	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