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

Not Applicable

Completed

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

• Registration Number: NCT06564480
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-24
• Primary Completion: 2024-02-01
• Study Completion: 2024-02-01
• Status Verified: 2024-08
• Study First Submitted: 2024-08-14
• Study First Submitted QC: 2024-08-20
• Last Update Submitted: 2024-08-20
• Study First Posted: 2024-08-21
• Last Update Posted: 2024-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment group	MI-R1 lower limb walking machine assisted training device	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.
control group	Walking rehabilitation training under the guidance of therapists	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Modified Barthel Index	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
Holden Walking Function Classification	through study completion, an average of one and a half year	Pedestrian function assessment on the 0th，14th and 28th day
Fugl Meyer Lower Limb Balance Assessment Scale Score on the 0th and 14th day	through study completion, an average of one and a half year	Lower limb function assessment

Trial Locations

Locations (1)

Zhejiang Hospital; 🇨🇳 Hangzhou, Zhejiang, China