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OpenTrials
Completed

NCT Number: NCT06830707

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 06351, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Comparison of the change in walking speed

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Acronym: CIMT

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 17, 2025
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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