Chronic StrokeCIMTNCT06830707
Effect of Lower Limb Constraint Induced Movement Therapy Using a Torque-Assisted Exoskeletal Wearable Device
A study testing experimental group in people with Chronic Stroke and Subacute Stroke, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Stroke, Subacute Stroke
- What is being tested?
- experimental group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Jul 2023to 23 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Being tested
- experimental group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimental groupDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: experimental group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 weeks follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start13 Jul 2023
- Primary completion8 Apr 2024
- Study completion23 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic StrokeStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Hyuk Chang, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830707
- Sponsor's protocol ID
- 2022-07-088
- Acronym
- CIMT
- Status last verified
- Jan 2025
- First submitted
- 13 Jan 2025
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06830707
- Acronym / sponsor ID
- CIMT / 2022-07-088
- Conditions
- Chronic Stroke, Subacute Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 13 Jul 2023 (actual)
- Primary completion
- 8 Apr 2024 (actual)
- Study completion
- 23 May 2024 (actual)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Torque-Assisted Exoskeletal Wearable Device group | Experimental | Device: experimental groupThe 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| experimental groupThe 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 | Torque-Assisted Exoskeletal Wearable Device group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing experimental group in people with Chronic Stroke and Subacute Stroke, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the change in walking speed (time frame: 3 weeks follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.