Visual Feedback Balance Training System Combined with RFE in Stroke

NCT ID: NCT06477445

Last Updated: 2024-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-31

Study Completion Date

2024-10-31

Brief Summary

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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

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Combination group

Visual feedback balance training system combined with RFE

Group Type EXPERIMENTAL

Visual feedback balance training system

Intervention Type DEVICE

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

Intervention Type OTHER

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.

RFE group

Repetitive facilitative exercise (RFE)

Group Type ACTIVE_COMPARATOR

repetitive facilitative exercise

Intervention Type OTHER

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.

CT group

Conventional therapy (CT)

Group Type ACTIVE_COMPARATOR

conventional therapy

Intervention Type OTHER

Basic training, including passive joint movement and activities of daily living exercise.

Interventions

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Visual 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.

Intervention Type DEVICE

repetitive facilitative exercise

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.

Intervention Type OTHER

conventional therapy

Basic training, including passive joint movement and activities of daily living exercise.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing Mingzhou Rehabilitation Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jingzhi Zhang

therapist-in-charge

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Jingzhi Zhang

Role: CONTACT

+86-16677137704

Other Identifiers

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NJKF202406002

Identifier Type: -

Identifier Source: org_study_id

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