Clinical trial NCT06564480: A Study on the Effectiveness Evaluation in Stroke Patients Using Lower Limb Assistive Walking Devices
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
Lower Extremity
Walking
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Zhejiang Hospital
name: Zhejiang Provincial Tongde Hospital
name: Zhejiang University
name: Sir Run Run Shaw Hospital
First posted: 2024-08-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Fugl Meyer Lower Limb Balance Assessment Scale Score on the 28th day
timeFrame: through study completion, an average of one and a half year
Secondary outcomes:
measure: Fugl Meyer Lower Limb Balance Assessment Scale Score on the 0th and 14th day
timeFrame: through study completion, an average of one and a half year
measure: Holden Walking Function Classification
timeFrame: through study completion, an average of one and a half year
measure: Modified Barthel Index
timeFrame: through study completion, an average of one and a half year
Other outcomes:
measure: Vital signs - temperature
timeFrame: through study completion, an average of one and a half year
measure: Vital signs - heart rate
timeFrame: through study completion, an average of one and a half year
measure: Vital signs - respiratory rate
timeFrame: through study completion, an average of one and a half year
measure: Vital signs - blood pressure
timeFrame: through study completion, an average of one and a half year
measure: Vital signs - pulse
timeFrame: through study completion, an average of one and a half year
measure: Adverse events
timeFrame: through study completion, an average of one and a half year
measure: Device defects checklist
timeFrame: through study completion, an average of one and a half year
Locations:
city: Hangzhou
country: China
facility: Zhejiang Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Fubon Technology Co., Ltd
name: Qinglong Gao
role: PRINCIPAL_INVESTIGATOR
References: