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

NCT06564480 | Completed

• 1 other identifier: 2023-205
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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. 1.Are patients using MI-R1 lower limb walking machine training more effective than those using traditional rehabilitation training?
2. 2.Is the MI-R1 lower limb walking machine safe?
3. 3.The experimental group received MI-R1 lower limb walking machine assisted training, while the control group received traditional rehabilitation training.
4. 4.Perform functional testing on the 0th, 14th, and 28th day of training.
5. 5.Observe whether there is any discomfort or safety during the rehabilitation training process.

Conditions

Stroke

Keywords

stroke; Lower Extremity; Walking

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• Holden Walking Function Classification

  through study completion, an average of one and a half year

• Modified Barthel Index

  through study completion, an average of one and a half year

Other Outcomes (7)

• Vital signs - temperature

  through study completion, an average of one and a half year

• Vital signs - heart rate

  through study completion, an average of one and a half year

• Vital signs - respiratory rate

  through study completion, an average of one and a half year

Study Arms (2)

treatment group

EXPERIMENTAL

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

control group

ACTIVE COMPARATOR

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

Interventions

MI-R1 lower limb walking machine assisted training device 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.

treatment group

Walking rehabilitation training under the guidance of therapists OTHER

Each patient undergoes training under the guidance of a rehabilitation therapist

control group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Zhejiang Hospital: collaborator
• Zhejiang Provincial Tongde Hospital: collaborator
• Zhejiang University: collaborator
• Sir Run Run Shaw Hospital: collaborator

Study Sites (1)

Zhejiang Hospital

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (1)

• Xiong B, Wang X, Xu X, Lou Z, Tong T, Gu D, Zhang K, Liu H. Effectiveness and safety of a lower-limb walking assist device for motor function recovery in subacute stroke patients: A prospective, randomized, open, parallel-controlled, noninferiority study. J Int Med Res. 2025 Nov;53(11):3000605251396301. doi: 10.1177/03000605251396301. Epub 2025 Nov 20.

  PMID: 41265879 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Qinglong Gao

  Zhejiang Fubon Technology Co., Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 21, 2024
• Study Start: May 24, 2022
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

CN (1)