StrokeNCT06564480
A Study on the Effectiveness Evaluation in Stroke Patients Using Lower Limb Assistive Walking Devices
A study testing MI-R1 lower limb walking machine assisted training device and Walking rehabilitation training under the guidance of therapists in people with Stroke, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The main purpose of this clinical trial is to evaluate the effectiveness and safety of the MI-R1 walking machine in lower limb motor function training for stroke patients. The main question is to answer: 1. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- MI-R1 lower limb walking machine assisted training device and Walking rehabilitation training under the guidance of therapists
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 24 May 2022to 1 Feb 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients diagnosed with stroke through CT or MRI, and only accompanied by hemiplegia on one side, with first-time onset or previous episodes without residual neurological dysfunction;
- Vital signs stable, neurological symptoms no longer aggravate after 48 hours, no severe cognitive impairment or aphasia, and cooperate with training;
- Modified Ashworth score for lower limb ≤ level 2, standing balance function level ≥1;
- Voluntarily participating in this trial, understanding and cooperating with the entire trial process, and signing a written informed consent form.
Who cannot join
- Bone, joint, muscle disease, or lower limb disabilities (such as severe osteoporosis, fractures, spinal instability, severely limited joint range of motion, severe limb muscle contractures, deformities, etc.) or diseases that affect balance and walking;
- Stroke caused by cerebellar brainstem injury and cortical injury;
- Patients with severe primary diseases such as cardiovascular, pulmonary, hepatic, renal, and hematopoietic systems, as well as critically ill and psychiatric patients;
- Other contraindications or complications that may affect walking training treatment;
- Patients with local skin damage or pressure ulcers in the lower limbs;
- Patients with peripheral nerve injury in the lower limbs;
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- Inappropriate body shape for robots (height<150cm or>190cm, or weight>85 kg);
- Planned pregnancy or pregnant and lactating women;
- Participants in other clinical trials within the past 3 months;
- Severe cognitive impairment;
- Known refusal or inability to comply with protocol requirements for any reason (including planned clinical visits and examinations);
- The researchers believe that it should not participate in this clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Parallel Controlled, Non Inferiority Clinical Trial Evaluating the Effectiveness and Safety of the Walker Assisted Device (Fubon Robot) in Lower Limb Motor Function for Stroke Patients
The main purpose of this clinical trial is to evaluate the effectiveness and safety of the MI-R1 walking machine in lower limb motor function training for stroke patients.
The main question is to answer:
Read more
- Are patients using MI-R1 lower limb walking machine training more effective than those using traditional rehabilitation training?
- Is the MI-R1 lower limb walking machine safe?
Participants will:
- The experimental group received MI-R1 lower limb walking machine assisted training, while the control group received traditional rehabilitation training.
- Perform functional testing on the 0th, 14th, and 28th day of training.
- Observe whether there is any discomfort or safety during the rehabilitation training process.
- Conditions
- Stroke
- Being tested
- MI-R1 lower limb walking machine assisted training device, Walking rehabilitation training under the guidance of therapists
- Keywords
- stroke, Lower Extremity, Walking
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MI-R1 lower limb walking machine assisted training deviceDevice
The training is conducted under partial weight support training conditions, performing passive movements on the lower limbs through motor drive, improving the joint activity of the patient's hip and knee joints, and achieving sitting, standing, and walking functions.
Walking rehabilitation training under the guidance of therapistsOther
Each patient undergoes training under the guidance of a rehabilitation therapist
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Patients received MI-R1 lower limb walking machine assisted training device based on their condition for the following training content:
1. Center of gravity transfer training;
2. Marking time and walking training;
3. Transfer training; 15 minutes each time, once a day, at least 5 times a week. Receives: Device: MI-R1 lower limb walking machine assisted training device |
| control group | Active comparator | Patients received walking rehabilitation training under the guidance of therapists based on their condition for the following training content:
1. Center of gravity transfer training;
2. Single leg weight-bearing training;
3. Marking time training assisted by balance bar；
4. Walking training assisted by balance bar; 15 minutes each time, once a day, at least 5 times a week. Receives: Other: Walking rehabilitation training under the guidance of therapists |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl Meyer Lower Limb Balance Assessment Scale Score on the 28th day
Lower limb function assessment
Measured: through study completion, an average of one and a half year
Secondary outcomes (3)
Fugl Meyer Lower Limb Balance Assessment Scale Score on the 0th and 14th day
Lower limb function assessment
Measured: through study completion, an average of one and a half year
Holden Walking Function Classification
Pedestrian function assessment on the 0th，14th and 28th day
Measured: through study completion, an average of one and a half year
Modified Barthel Index
Assessment of activities of daily living ability on the 0th，14th and 28th day
Measured: through study completion, an average of one and a half year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start24 May 2022
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Hospital, Zhejiang Provincial Tongde Hospital, Zhejiang University, Sir Run Run Shaw Hospital
- Responsible party
- Sponsor
- Investigators
- Qinglong Gao, Principal investigator, Zhejiang Fubon Technology Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06564480
- Sponsor's protocol ID
- 2023-205
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xiong B, Wang X, Xu X, Lou Z, Tong T, Gu D, Zhang K, Liu H. Effectiveness and safety of a lower-limb walking assist device for motor function recovery in subacute stroke patients: A prospective, randomized, open, parallel-controlled, noninferiority study. J Int Med Res. 2025 Nov;53(11):3000605251396301. doi: 10.1177/03000605251396301. Epub 2025 Nov 20.
PubMed 41265879
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Parallel Controlled, Non Inferiority Clinical Trial Evaluating the Effectiveness and Safety of the Walker Assisted Device (Fubon Robot) in Lower Limb Motor Function for Stroke Patients
- ClinicalTrials.gov ID
- NCT06564480
- Acronym / sponsor ID
- 2023-205
- Conditions
- Stroke
- Keywords
- stroke, Lower Extremity, Walking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Zhejiang Hospital, Zhejiang Provincial Tongde Hospital, Zhejiang University, Sir Run Run Shaw Hospital
- Study start
- 24 May 2022 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 21 Aug 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 main purpose of this clinical trial is to evaluate the effectiveness and safety of the MI-R1 walking machine in lower limb motor function training for stroke patients.
The main question is to answer:
- Are patients using MI-R1 lower limb walking machine training more effective than those using traditional rehabilitation training?
- Is the MI-R1 lower limb walking machine safe?
Participants will:
- The experimental group received MI-R1 lower limb walking machine assisted training, while the control group received traditional rehabilitation training.
- Perform functional testing on the 0th, 14th, and 28th day of training.
- Observe whether there is any discomfort or safety during the rehabilitation training process.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Device: MI-R1 lower limb walking machine assisted training devicePatients received MI-R1 lower limb walking machine assisted training device based on their condition for the following training content: 1. Center of gravity transfer training; 2. Marking time and walking training; 3. Transfer training; 15 minutes each time, once a day, at least 5 times a week. |
| control group | Active comparator | Other: Walking rehabilitation training under the guidance of therapistsPatients received walking rehabilitation training under the guidance of therapists based on their condition for the following training content: 1. Center of gravity transfer training; 2. Single leg weight-bearing training; 3. Marking time training assisted by balance bar； 4. Walking training assisted by balance bar; 15 minutes each time, once a day, at least 5 times a week. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with stroke through CT or MRI, and only accompanied by hemiplegia on one side, with first-time onset or previous episodes without residual neurological dysfunction;
- Vital signs stable, neurological symptoms no longer aggravate after 48 hours, no severe cognitive impairment or aphasia, and cooperate with training;
- Modified Ashworth score for lower limb ≤ level 2, standing balance function level ≥1;
- Voluntarily participating in this trial, understanding and cooperating with the entire trial process, and signing a written informed consent form.
Key exclusion criteria (12 listed)
- Bone, joint, muscle disease, or lower limb disabilities (such as severe osteoporosis, fractures, spinal instability, severely limited joint range of motion, severe limb muscle contractures, deformities, etc.) or diseases that affect balance and walking;
- Stroke caused by cerebellar brainstem injury and cortical injury;
- Patients with severe primary diseases such as cardiovascular, pulmonary, hepatic, renal, and hematopoietic systems, as well as critically ill and psychiatric patients;
- Other contraindications or complications that may affect walking training treatment;
- Patients with local skin damage or pressure ulcers in the lower limbs;
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 |
|---|---|---|
| MI-R1 lower limb walking machine assisted training deviceThe training is conducted under partial weight support training conditions, performing passive movements on the lower limbs through motor drive, improving the joint activity of the patient's hip and knee joints, and achieving sitting, standing, and walking functions. | Device | treatment group |
| Walking rehabilitation training under the guidance of therapistsEach patient undergoes training under the guidance of a rehabilitation therapist | Other | control group |
Primary outcome
Fugl Meyer Lower Limb Balance Assessment Scale Score on the 28th day
Time frame: through study completion, an average of one and a half year
Lower limb function assessment
3 secondary outcomes
Fugl Meyer Lower Limb Balance Assessment Scale Score on the 0th and 14th day
Time frame: through study completion, an average of one and a half year
Holden Walking Function Classification
Time frame: through study completion, an average of one and a half year
Modified Barthel Index
Time frame: through study completion, an average of one and a half year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Derived from this study: PubMed 41265879Xiong B, Wang X, Xu X, Lou Z, Tong T, Gu D, Zhang K, Liu H. Effectiveness and safety of a lower-limb walking assist device for motor function recovery in subacute stroke patients: A prospective, randomized, open, parallel-controlled, noninferiority study. J Int Med Res. 2025 Nov;53(11):3000605251396301. doi: 10.1177/03000605251396301. Epub 2025 Nov 20.
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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.
Qinglong Gao principal investigator
Zhejiang Fubon Technology Co., Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MI-R1 lower limb walking machine assisted training device and Walking rehabilitation training under the guidance of therapists in people with Stroke, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 12 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: finished, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl Meyer Lower Limb Balance Assessment Scale Score on the 28th day (time frame: through study completion, an average of one and a half year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06564480, which also lists 1 linked publication.
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 21 Aug 2024; AzTrials last refreshed its copy on 28 Oct 2026.