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

NCT ID: NCT06564480

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-24
• Study Completion Date: 2024-02-01

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

MI-R1 lower limb walking machine assisted training device

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Walking rehabilitation training under the guidance of therapists

Intervention Type: OTHER

Each patient undergoes training under the guidance of a rehabilitation therapist

Interventions

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.

Intervention Type: DEVICE

Walking rehabilitation training under the guidance of therapists

Each patient undergoes training under the guidance of a rehabilitation therapist

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zhejiang Hospital

OTHER

Sponsor Role: collaborator

Zhejiang Provincial Tongde Hospital

OTHER

Sponsor Role: collaborator

Zhejiang University

OTHER

Sponsor Role: collaborator

Sir Run Run Shaw Hospital

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qinglong Gao

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Fubon Technology Co., Ltd

Locations

Zhejiang Hospital

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

2023-205

Identifier Type: -

Identifier Source: org_study_id