Stroke
Conditions
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
Interventions
DEVICEVisual feedback balance training system
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.
OTHERconventional therapy
Basic training, including passive joint movement and activities of daily living exercise.
Sponsors
Nanjing Mingzhou Rehabilitation Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | From enrollment to the end of treatment at 4 weeks | Use the Libra parameters evaluation system included with visual feedback balance training system |
| Deviation of bilateral center of gravity movement area | From enrollment to the end of treatment at 4 weeks | Use the Libra parameters evaluation system included with visual feedback balance training system |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| functional ambulation category scale (FAC) | From enrollment to the end of treatment at 4 weeks |
Contacts
Primary ContactJingzhi Zhang
Outcome results
None listed