Visual Feedback Balance Training System Combined with RFE in Stroke
Effect of Visual Feedback Balance Training System Combined with Repetitive Facilitative Exercise on Fall Risk After Stroke: a Randomized Control Trial
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
The goal of this clinical trial is to learn if visual feedback balance training system combined with repetitive facilitative exercise (RFE) work to treat stroke in adults. The main questions it aims to answer are: Does visual feedback balance training system combined with RFE reduce the fall risk of participants? Can the combination of intelligent rehabilitation robot training system and RFE achieve better effects? Researchers will compare 3 groups (RFE, visual feedback balance training system under RFE, and conventional therapy) to see if visual feedback balance training system and RFE works to treat stroke. Participants will: Receive treatment for 4 weeks Receive scale and instrument testing before and after treatment
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Jul 2024
Shorter than P25 for not_applicable stroke
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
June 21, 2024
CompletedFirst Posted
Study publicly available on registry
June 27, 2024
CompletedStudy Start
First participant enrolled
July 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2024
CompletedJune 27, 2024
June 1, 2024
2 months
June 21, 2024
June 21, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
time up and go test (TUG)
From enrollment to the end of treatment at 4 weeks
10-meter walk test (10-MWT)
From enrollment to the end of treatment at 4 weeks
Center of gravity loss index
Use the Libra parameters evaluation system included with visual feedback balance training system
From enrollment to the end of treatment at 4 weeks
Deviation of bilateral center of gravity movement area
Use the Libra parameters evaluation system included with visual feedback balance training system
From enrollment to the end of treatment at 4 weeks
Secondary Outcomes (3)
functional ambulation category scale (FAC)
From enrollment to the end of treatment at 4 weeks
Fugl-Meyer Assessment (FMA)
From enrollment to the end of treatment at 4 weeks
Berg balance scale (BBS)
From enrollment to the end of treatment at 4 weeks
Study Arms (3)
Combination group
EXPERIMENTALVisual feedback balance training system combined with RFE
RFE group
ACTIVE COMPARATORRepetitive facilitative exercise (RFE)
CT group
ACTIVE COMPARATORConventional therapy (CT)
Interventions
Using an visual feedback balance training system to provide a dynamic balance training platform for patients to perform balance training based on visual feedback.
Repetitive facilitative exercise (RFE) is a new technology that combines multiple sensory stimuli and achieves facilitation and reinforcement of the reconstruction of paralyzed neural pathways through repeated and extensive directional exercise.
Basic training, including passive joint movement and activities of daily living exercise.
Eligibility Criteria
You may qualify if:
- patients (18 to 74 years old) who suffered a first or second unilateral stroke
- chronic stroke (over 6 months from the onset)
- moderate or higher risk of falls (TUG \> 15s, or 10-MWT ≤ 0.8m/s)
- ability to understand and follow simple directions
You may not qualify if:
- pregnant or lactating
- lower extremity contracture, pain, or trauma
- perceptual, apraxic, or cognitive deficits that lead to inability to follow verbal instructions
- unable to maintain standing posture
- cerebellar lesion
- clinically unstable medical disorders
- inability to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- therapist-in-charge
Study Record Dates
First Submitted
June 21, 2024
First Posted
June 27, 2024
Study Start
July 1, 2024
Primary Completion
September 1, 2024
Study Completion
October 1, 2024
Last Updated
June 27, 2024
Record last verified: 2024-06