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CompletedNCT06830707CIMTUpdated Feb 17, 2025

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

An interventional study of experimental group in Chronic Stroke and Subacute Stroke, sponsored by Samsung Medical Center. Completed at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-02-17.

Sponsored by Samsung Medical Center · Not applicable, Interventional, and Device feasibility

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Jul 2023, registered Jan 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
19 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Stroke
  • Subacute Stroke
03

In context

Lead sponsor

Samsung Medical Center is the lead sponsor of 1,005 studies on the registry; 148 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Torque-Assisted Exoskeletal Wearable Device 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.

    Device: experimental group

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.

06

What researchers measure

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

    Time frame: 3 weeks follow up

07

Study locations

1 site
  • Samsung Medical Center
    Seoul, 06351, South Korea
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06830707
Responsible party
Won Hyuk Chang (professor, Samsung Medical Center) — Principal investigator
First posted
Feb 17, 2025
Start date
Jul 13, 2023
Primary completion
Apr 8, 2024
Completion
May 23, 2024
Last update
Feb 17, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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