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

Not Applicable

Completed

• Conditions: Chronic Stroke; Subacute Stroke

• Registration Number: NCT06830707
• Lead Sponsor: Samsung Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-13
• Primary Completion: 2024-04-08
• Study Completion: 2024-05-23
• Status Verified: 2025-01
• Study First Submitted: 2025-01-13
• Study First Submitted QC: 2025-02-12
• Last Update Submitted: 2025-02-12
• Study First Posted: 2025-02-17
• Last Update Posted: 2025-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Comparison of the change in walking speed	3 weeks follow up	Comparison of the change in walking speed before and after 5 sessions of walking training versus 10 sessions of CIMT exercise training

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of