NCT06543758RecruitingPhase 4
Effectiveness and Safety of At-home Gait Rehabilitation Using Wearable Exoskeletal Robot
Study to Verify Effectiveness and Safety of At-home Gait Rehabilitation Using Wearable Exoskeletal Robot to Improve Gait in Stroke Patients, Investigator Initiated, Single Center, Single Group Trial
Source: ClinicalTrials.gov · Last updated 19 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this clinical trial is to evaluate the effectiveness and safety of a home-based robotic-assisted gait rehabilitation service using a wearable exoskeletal robot for stroke patients. The main questions it aims to answer are: * Can home-based robotic-assisted gait training improve walking speed in stroke patients? * Does this intervention enhance body composition, gait patterns, balance in participants? * How satisfied are participants with the use of the wearable exoskeletal robot ? Researchers will compare pre- and post-intervention walking speeds, body composition, spatiotemporal parameters, balance, and satisfaction survey and does not establish a control group. Participants will: * Wear a wearable exoskeletal robot for gait training. * Undergo 10 sessions of 30-minute gait training over 4 weeks at home or in nearby indoor spaces. * Participate in physical function assessments including the 10-meter walk test, Timed Up and Go (TUG) test, and Berg Balance Scale before and after the intervention. * Complete quality of life and depression inventories before and after the intervention.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 16 (estimated)
- First submitted
- 24 Jul 2024
- Start date
- 1 Aug 2024
- Primary completion date
- 31 Jul 2025
- Lead sponsor
- Yonsei University
- Diseases
- Stroke
- NCT number
- NCT06543758
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 16
- From 1 Aug 2024 to the primary completion date, 31 Jul 2025
- 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
- individuals with skin conditions or open wounds that prevent device usage.
- individuals at high risk of fractures due to conditions like osteoporosis.
- individuals with severe cognitive impairment (Mini-Mental State Examination score \< 20), delirium, or severe language impairment that hinders cooperation with wearable exoskeletal robot gait training.
- individuals unable to maintain prolonged standing or walking due to conditions like orthostatic hypotension or cardiopulmonary impairment.
- individuals with conditions affecting gait, such as peripheral neuropathy, Parkinsonism, or those with alcohol dependence or severe diabetes.
- individuals at high risk of falls or bleeding due to conditions like coagulopathies.
Other
- individuals with severe joint contractures or osteoporosis, or untreated fractures that contraindicate weight-bearing on the lower limbs.
- individuals with significant differences in leg length.
- individuals with severe deformities or joint contractures in the lower limbs.
- individuals unable to maintain a sitting or standing position independently.
- individuals with severe lower limb spasticity (Modified Ashworth Scale grade 2 or higher).
- pregnant women or those who could become pregnant.
- individuals participating in other clinical trials.
- individuals shorter than 140 cm, taller than 190 cm, or weighing over 80 kg.
- individuals with other clinical findings deemed inappropriate for the study by the principal investigator or study coordinator.
Who the study is looking for
- adults aged 19 to 79 years (based on the age on their national ID at the time of consent)
- individuals diagnosed with cerebral infarction or intracerebral hemorrhage confirmed by MRI or CT.
- patients who have passed at least one month since stroke diagnosis.
- individuals exhibiting spastic hemiplegic gait patterns due to stroke.
- patients with a Functional Ambulatory Category score of less than 4.
- individuals who can sit on the edge of a bed without assistance and stand for 10 seconds with or without assistance.
- individuals with sufficient cognitive ability to follow simple instructions and understand the study's content and purpose (Mini-Mental State Examination score \>= 20)
Age in the registry: 19 years to 79 years · 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 |
|---|---|---|---|
| Yongin Severance Hospital Coordinator of this site? Confirm its status | Yongin-si | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.