StrokeNCT06477445
Visual Feedback Balance Training System Combined with RFE in Stroke
A study testing Visual feedback balance training system, repetitive facilitative exercise and conventional therapy in people with Stroke, run by Nanjing Mingzhou Rehabilitation Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Stroke
- What is being tested?
- Visual feedback balance training system, repetitive facilitative exercise and conventional therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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?
Read more
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
- Conditions
- Stroke
- Being tested
- Visual feedback balance training system, repetitive facilitative exercise, conventional therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual feedback balance training systemDevice
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 exerciseOther
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.
conventional therapyOther
Basic training, including passive joint movement and activities of daily living exercise.
| Study group | Role | What they receive |
|---|---|---|
| Combination group | Experimental | Visual feedback balance training system combined with RFE Receives: Device: Visual feedback balance training system; Other: repetitive facilitative exercise |
| RFE group | Active comparator | Repetitive facilitative exercise (RFE) Receives: Other: repetitive facilitative exercise |
| CT group | Active comparator | Conventional therapy (CT) Receives: Other: conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
time up and go test (TUG)
Measured: From enrollment to the end of treatment at 4 weeks
10-meter walk test (10-MWT)
Measured: From enrollment to the end of treatment at 4 weeks
Center of gravity loss index
Use the Libra parameters evaluation system included with visual feedback balance training system
Measured: From enrollment to the end of treatment at 4 weeks
Deviation of bilateral center of gravity movement area
Use the Libra parameters evaluation system included with visual feedback balance training system
Measured: From enrollment to the end of treatment at 4 weeks
Secondary outcomes (3)
functional ambulation category scale (FAC)
Measured: From enrollment to the end of treatment at 4 weeks
Fugl-Meyer Assessment (FMA)
Measured: From enrollment to the end of treatment at 4 weeks
Berg balance scale (BBS)
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study startJul 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Mingzhou Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingzhi Zhang, Nanjing Mingzhou Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06477445
- Sponsor's protocol ID
- NJKF202406002
- Status last verified
- Jun 2024
- First submitted
- 21 Jun 2024
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Visual Feedback Balance Training System Combined with Repetitive Facilitative Exercise on Fall Risk After Stroke: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06477445
- Acronym / sponsor ID
- NJKF202406002
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nanjing Mingzhou Rehabilitation HospitalUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Combination group | Experimental | Device: Visual feedback balance training system, Other: repetitive facilitative exerciseVisual feedback balance training system combined with RFE |
| RFE group | Active comparator | Other: repetitive facilitative exerciseRepetitive facilitative exercise (RFE) |
| CT group | Active comparator | Other: conventional therapyConventional therapy (CT) |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual feedback balance training systemUsing an visual feedback balance training system to provide a dynamic balance training platform for patients to perform balance training based on visual feedback. | Device | Combination group |
| repetitive facilitative exerciseRepetitive 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. | Other | Combination group, RFE group |
| conventional therapyBasic training, including passive joint movement and activities of daily living exercise. | Other | CT group |
Primary outcome
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
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
3 secondary outcomes
functional ambulation category scale (FAC)
Time frame: 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
Berg balance scale (BBS)
Time frame: From enrollment to the end of treatment at 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Visual feedback balance training system, repetitive facilitative exercise and conventional therapy in people with Stroke, run by Nanjing Mingzhou Rehabilitation Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jingzhi Zhang (+86-16677137704, 170787717@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time up and go test (TUG) (time frame: From enrollment to the end of treatment at 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.