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

Effect of Lower Limb Constraint Induced Movement Therapy Using a Torque-Assisted Exoskeletal Wearable Device on Ambulatory Function in Late Subacute and Chronic Stroke Patients, Single-Center, Single-blinded Cross-over Prospective Pilot Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06830707
Acronym
CIMT
Enrollment
16
Registered
2025-02-17
Start date
2023-07-13
Completion date
2024-05-23
Last updated
2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Stroke, Subacute Stroke

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.

Interventions

DEVICEexperimental 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.

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Comparison of the change in walking speed3 weeks follow upComparison of the change in walking speed before and after 5 sessions of walking training versus 10 sessions of CIMT exercise training

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026