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

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: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: MI-R1 lower limb walking machine assisted training device; Other: Walking rehabilitation training under the guidance of therapists

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment group; Patients received MI-R1 lower limb walking machine assisted training device based on their condition for the following training content: Center of gravity transfer training;; Marking time and walking training;; 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: Center of gravity transfer training;; Single leg weight-bearing training;; Marking time training assisted by balance bar；; 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

Outcome Measure	Measure Description	Time Frame
Fugl Meyer Lower Limb Balance Assessment Scale Score on the 28th day	Lower limb function assessment	through study completion, an average of one and a half year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl Meyer Lower Limb Balance Assessment Scale Score on the 0th and 14th day	Lower limb function assessment	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	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	through study completion, an average of one and a half year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vital signs - temperature	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	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	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	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	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	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	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

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: Zhejiang University; Sir Run Run Shaw Hospital; Zhejiang Provincial Tongde Hospital; Zhejiang Hospital
• Investigators: Principal Investigator: Qinglong Gao, Zhejiang Fubon Technology Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2022
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: August 14, 2024
• First Submitted That Met QC Criteria: August 20, 2024
• First Posted (Actual): August 21, 2024

Study Record Updates

• Last Update Posted (Actual): August 21, 2024
• Last Update Submitted That Met QC Criteria: August 20, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: stroke; Walking; Lower Extremity
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID 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