Effect of Lower Limb Constraint Induced Movement Therapy Using a Torque-Assisted Exoskeletal Wearable Device (CIMT)

Samsung Medical Center

Status: Completed

Conditions: Subacute Stroke; Chronic Stroke

Treatments: Device: experimental group

Study type: Interventional

Funder types: Other

Identifiers

NCT06830707

2022-07-088

Details and patient eligibility

About

The aim of this study was to investigate the effects of lower limb constraint induced motor therapy using the robotic rehabilitation device on ambulatory function in chronic stroke patients.

Enrollment: 16 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults aged 19 years or older
• 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 severe cognitive impairment (MMSE <10) or significant communication difficulties such as speech disorders
• 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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Torque-Assisted Exoskeletal Wearable Device group

Experimental group

Description:

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.

Treatment:

Device: experimental group