NCT06830707Completed
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
Source: ClinicalTrials.gov · Last updated 17 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 16 (actual)
- First submitted
- 13 Jan 2025
- Start date
- 13 Jul 2023
- Primary completion date
- 8 Apr 2024
- Lead sponsor
- Samsung Medical Center
- Diseases
- Stroke
- NCT number
- NCT06830707
What you commit to
- Study type: Interventional
- Participants enrolled: 16
- From 13 Jul 2023 to the primary completion date, 8 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with severe cognitive impairment (MMSE \<10) or significant communication difficulties such as speech disorders
- Patients with severe musculoskeletal disorders of 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.)
Other
- Patients with spasticity in one-sided lower limbs, rated 2 or higher on the Modified Ashworth Scale (MAS)
- 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
- Any other cases where the investigator determines that participation in this study is inappropriate
Who the study is looking for
- 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)
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.