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Clinical Trials/NCT06477445
NCT06477445
Not Yet Recruiting
N/A

Effect of Visual Feedback Balance Training System Combined with Repetitive Facilitative Exercise on Fall Risk After Stroke: a Randomized Control Trial

Nanjing Mingzhou Rehabilitation Hospital0 sites60 target enrollmentJuly 2024
ConditionsStroke

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
Nanjing Mingzhou Rehabilitation Hospital
Enrollment
60
Primary Endpoint
Deviation of bilateral center of gravity movement area
Status
Not Yet Recruiting
Last Updated
last year

Overview

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

Registry
clinicaltrials.gov
Start Date
July 2024
End Date
October 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Nanjing Mingzhou Rehabilitation Hospital
Responsible Party
Principal Investigator
Principal Investigator

Jingzhi Zhang

therapist-in-charge

Nanjing Mingzhou Rehabilitation Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Deviation of bilateral center of gravity movement area

Time Frame: From enrollment to the end of treatment at 4 weeks

Use the Libra parameters evaluation system included with visual feedback balance training system

time up and go test (TUG)

Time Frame: From enrollment to the end of treatment at 4 weeks

10-meter walk test (10-MWT)

Time Frame: From enrollment to the end of treatment at 4 weeks

Center of gravity loss index

Time Frame: From enrollment to the end of treatment at 4 weeks

Use the Libra parameters evaluation system included with visual feedback balance training system

Secondary Outcomes

  • Fugl-Meyer Assessment (FMA)(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)
  • Berg balance scale (BBS)(From enrollment to the end of treatment at 4 weeks)

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