Visual Feedback Balance Training System Combined with RFE in Stroke
ConditionStroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-74
SponsorNanjing Mingzhou Rehabilitation Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Visual feedback balance training system
DeviceUsing 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
Other interventionRepetitive 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.
conventional therapy
Other interventionBasic training, including passive joint movement and activities of daily living exercise.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Combination groupExperimental treatment 2 interventions
Group B: RFE groupActive comparator 1 intervention
Group C: CT groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
time up and go test (TUG)
Time frame
From enrollment to the end of treatment at 4 weeks2
10-meter walk test (10-MWT)
Time frame
From enrollment to the end of treatment at 4 weeks3
Center of gravity loss index
Use the Libra parameters evaluation system included with visual feedback balance training system
Time frame
From enrollment to the end of treatment at 4 weeks4
Deviation of bilateral center of gravity movement area
Use the Libra parameters evaluation system included with visual feedback balance training system
Time frame
From enrollment to the end of treatment at 4 weeksSecondary outcomes
1
functional ambulation category scale (FAC)
Time frame
From enrollment to the end of treatment at 4 weeks2
Fugl-Meyer Assessment (FMA)
Time frame
From enrollment to the end of treatment at 4 weeks3
Berg balance scale (BBS)
Time frame
From enrollment to the end of treatment at 4 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: