Effect of Lower Limb Constraint Induced Movement Therapy Using a Torque-Assisted Exoskeletal Wearable Device
NCT ID: NCT06830707
Last Updated: 2025-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
16 participants
INTERVENTIONAL
2023-07-13
2024-05-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Torque-Assisted Exoskeletal Wearable Device group
The treatment comprised 5 robot-assisted gait training sessions over a 2-week period, followed by 10 lower limb Constraint Induced Movement Therapy(CIMT) sessions with a torque assisted exoskeleton.
experimental group
The treatment comprised 5 robot-assisted gait training sessions over a 2-week period, followed by 10 lower limb Constraint Induced Movement Therapy(CIMT) sessions with a torque assisted exoskeleton.
Interventions
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experimental group
The treatment comprised 5 robot-assisted gait training sessions over a 2-week period, followed by 10 lower limb Constraint Induced Movement Therapy(CIMT) sessions with a torque assisted exoskeleton.
Eligibility Criteria
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Inclusion Criteria
* Patients with hemiparesis due to ischemic or hemorrhagic stroke
* Patients in the late subacute or chronic phase, at least 3 months after the onset of stroke
* Individuals who can independently walk with a Functional Ambulatory Category score of 3 or higher
* Patients who are able to use Torque-Assisted Exoskeletal Wearable Device Height: 140 cm to 190 cm Weight: 80 kg or less Shoe size: 230 mm to 290 mm
* Patients who were independent walkers and had no difficulties performing activities of daily living (mRS ≤ 1)
Exclusion Criteria
* Patients with spasticity in one-sided lower limbs, rated 2 or higher on the Modified Ashworth Scale (MAS)
* Patients with severe musculoskeletal disorders of the lower limbs
* Patients with contractures that limit the range of motion in the lower limbs
* Patients with an apparent leg length discrepancy of 2 cm or more
* Patients with fractures, open trauma, or non-healing ulcers in the lower limbs
* Patients with serious internal diseases such as cardiovascular disease or pulmonary disease that make it difficult to use Exoskeletal Wearable Device for walking therapy
* Patients with a history of osteoporotic fractures
* Patients with other neurological disorders affecting walking (e.g., Parkinson's disease, multiple sclerosis, etc.)
* Any other cases where the investigator determines that participation in this study is inappropriate
19 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Won Hyuk Chang
professor
Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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2022-07-088
Identifier Type: -
Identifier Source: org_study_id
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