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

Zhejiang University

Status: Completed

Conditions: Stroke

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06564480

2023-205

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

treatment group

Experimental group

Description:

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.

Treatment:

Device: MI-R1 lower limb walking machine assisted training device

control group

Active Comparator group

Description:

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.

Treatment:

Other: Walking rehabilitation training under the guidance of therapists