NCT06000904

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

October 19, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

June 26, 2024

Status Verified

June 1, 2024

Enrollment Period

1.2 years

First QC Date

August 6, 2023

Last Update Submit

June 25, 2024

Conditions

Stroke

Keywords

Turning performanceBalance performanceExergameBalance trainingStroke

Outcome Measures

Primary Outcomes (5)

  • Turning velocity (degrees/second)

    Change from baseline at 4 weeks

  • Number of steps taken during turning

    Change from baseline at 4 weeks

  • 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

Secondary Outcomes (9)

  • Berg Balance Scale

    Change from baseline at 4 weeks

  • Limits of stability test

    Change from baseline at 4 weeks

  • Modified clinical test of sensory interaction in balance

    Change from baseline at 4 weeks

  • Walking velocity (cm/sec) in straight walk

    Change from baseline at 4 weeks

  • Step length (cm) in straight walk

    Change from baseline at 4 weeks

  • +4 more secondary outcomes

Study Arms (2)

Exergame-based balance training group

EXPERIMENTAL
Other: Exergame-based balance training

Upper limb and trunk training group

ACTIVE COMPARATOR
Other: Upper limb and trunk training

Interventions

Exergame-based balance trainingOTHER

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.

Exergame-based balance training group
Upper limb and trunk trainingOTHER

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.

Upper limb and trunk training group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Taipei, 112, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 6, 2023

First Posted

August 21, 2023

Study Start

October 19, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

June 26, 2024

Record last verified: 2024-06

Locations

TW(1)