A Study on the Effectiveness Evaluation in Stroke Patients Using Lower Limb Assistive Walking Devices

August 20, 2024 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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:

  1. Are patients using MI-R1 lower limb walking machine training more effective than those using traditional rehabilitation training?
  2. Is the MI-R1 lower limb walking machine safe?

Participants will:

  1. The experimental group received MI-R1 lower limb walking machine assisted training, while the control group received traditional rehabilitation training.
  2. Perform functional testing on the 0th, 14th, and 28th day of training.
  3. Observe whether there is any discomfort or safety during the rehabilitation training process.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Zhejiang Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • 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.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: treatment group

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.
Device: MI-R1 lower limb walking machine assisted training device
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.
Active Comparator: control group

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.
Other: Walking rehabilitation training under the guidance of therapists
Each patient undergoes training under the guidance of a rehabilitation therapist

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of one and a half year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Lower limb function assessment
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
Pedestrian function assessment on the 0th，14th and 28th day
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
Assessment of activities of daily living ability on the 0th，14th and 28th day
through study completion, an average of one and a half year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Vital signs - temperature
Time Frame: through study completion, an average of one and a half year
Measure the patient's body temperature on the 0th, 14th, and 28th days of training
through study completion, an average of one and a half year
Vital signs - heart rate
Time Frame: through study completion, an average of one and a half year
Measure the patient's heart rate on the 0th, 14th, and 28th days of training
through study completion, an average of one and a half year
Vital signs - respiratory rate
Time Frame: through study completion, an average of one and a half year
Measure the patient's respiratory rate on the 0th, 14th, and 28th days of training
through study completion, an average of one and a half year
Vital signs - blood pressure
Time Frame: through study completion, an average of one and a half year
Measure the patient's blood pressure on the 0th, 14th, and 28th days of training
through study completion, an average of one and a half year
Vital signs - pulse
Time Frame: through study completion, an average of one and a half year
Measure the patient's pulse on the 0th, 14th, and 28th days of training
through study completion, an average of one and a half year
Adverse events
Time Frame: through study completion, an average of one and a half year
Number of participants with treatment-related adverse events as assessed by "Criteria for determining adverse events"
through study completion, an average of one and a half year
Device defects checklist
Time Frame: through study completion, an average of one and a half year
The risks to health and safety that may arise from the normal use of medical devices, including quality and malfunctions
through study completion, an average of one and a half year

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Zhejiang University
Sir Run Run Shaw Hospital
Zhejiang Provincial Tongde Hospital
Zhejiang Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Qinglong Gao, Zhejiang Fubon Technology Co., Ltd

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 24, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 21, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-205

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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