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NCT06564480Completed

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

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

Source: ClinicalTrials.gov · Last updated 21 Aug 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
100 (actual)
First submitted
14 Aug 2024
Start date
24 May 2022
Primary completion date
1 Feb 2024
Lead sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Diseases
Stroke
NCT number
NCT06564480

What you commit to

  • Study type: Interventional
  • Participants enrolled: 100
  • From 24 May 2022 to the primary completion date, 1 Feb 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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;
  • Severe cognitive impairment;

Other

  • 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;
  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 85 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Zhejiang Hospital
Coordinator of this site? Confirm its status
HangzhouChinaUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.