Visual Feedback Balance Training System Combined with RFE in Stroke

June 21, 2024 updated by: Jingzhi Zhang, Nanjing Mingzhou Rehabilitation Hospital

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

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time up and go test (TUG)
Time Frame: From enrollment to the end of treatment at 4 weeks
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
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
From enrollment to the end of treatment at 4 weeks
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
From enrollment to the end of treatment at 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
functional ambulation category scale (FAC)
Time Frame: From enrollment to the end of treatment at 4 weeks
From enrollment to the end of treatment at 4 weeks
Fugl-Meyer Assessment (FMA)
Time Frame: From enrollment to the end of treatment at 4 weeks
From enrollment to the end of treatment at 4 weeks
Berg balance scale (BBS)
Time Frame: From enrollment to the end of treatment at 4 weeks
From enrollment to the end of treatment at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Mingzhou Rehabilitation Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

June 21, 2024

First Submitted That Met QC Criteria

June 21, 2024

First Posted (Actual)

June 27, 2024

Study Record Updates

Last Update Posted (Actual)

June 27, 2024

Last Update Submitted That Met QC Criteria

June 21, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NJKF202406002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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