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

NCT06830707 | Completed

• 1 other identifier: 2022-07-088
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Stroke; Subacute Stroke

Outcome Measures

Primary Outcomes (1)

• Comparison of the change in walking speed

  Comparison of the change in walking speed before and after 5 sessions of walking training versus 10 sessions of CIMT exercise training

  3 weeks follow up

Study Arms (1)

Torque-Assisted Exoskeletal Wearable Device group

EXPERIMENTAL

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.

Device: experimental group

Interventions

experimental group DEVICE

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.

Torque-Assisted Exoskeletal Wearable Device group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: February 17, 2025
• Study Start: July 13, 2023
• Primary Completion: April 8, 2024
• Study Completion: May 23, 2024
• Last Updated: February 17, 2025

Record last verified: 2025-01

Locations

KR (1)