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Completed

NCT Number: NCT06564480

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhejiang Hospital

Hangzhou, Zhejiang, 310000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Walking rehabilitation training under the guidance of therapists

Other

Each patient undergoes training under the guidance of a rehabilitation therapist

Primary outcomes

  1. Fugl Meyer Lower Limb Balance Assessment Scale Score on the 28th day

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

    Lower limb function assessment

Secondary outcomes

  1. Fugl Meyer Lower Limb Balance Assessment Scale Score on the 0th and 14th day

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

    Lower limb function assessment

  2. Holden Walking Function Classification

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

    Pedestrian function assessment on the 0th,14th and 28th day

  3. Modified Barthel Index

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

    Assessment of activities of daily living ability on the 0th,14th and 28th day

Other outcomes

  1. Vital signs - temperature

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

    Measure the patient's body temperature on the 0th, 14th, and 28th days of training

  2. Vital signs - heart rate

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

    Measure the patient's heart rate on the 0th, 14th, and 28th days of training

  3. Vital signs - respiratory rate

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

    Measure the patient's respiratory rate on the 0th, 14th, and 28th days of training

  4. Vital signs - blood pressure

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

    Measure the patient's blood pressure on the 0th, 14th, and 28th days of training

  5. Vital signs - pulse

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

    Measure the patient's pulse on the 0th, 14th, and 28th days of training

  6. Adverse events

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

    Number of participants with treatment-related adverse events as assessed by "Criteria for determining adverse events"

  7. Device defects checklist

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

    The risks to health and safety that may arise from the normal use of medical devices, including quality and malfunctions

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Collaborators

  • Sir Run Run Shaw Hospital
  • Zhejiang Hospital
  • Zhejiang Provincial Tongde Hospital
  • Zhejiang University

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 21, 2024
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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