StrokeNCT07716475
Evaluate the Effectiveness and Safety of At-Home Rehabilitation Gait Training Using a Hip-assisted Wearable Robot in Stroke Patients
A study testing hip-assisted wearable robot in people with Stroke, run by Yonsei University at 1 site in South Korea.
Trial summary
The goal of this clinical trial is to learn whether a wearable monitoring system can help adults who have had a stroke get more out of a home exercise program. The system tracks how participants walk and move, then gives them feedback. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- hip-assisted wearable robot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Jul 2026to 30 Jul 2027
- Phase
- Interventional
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 19 years or older and under 80 years
- Persons diagnosed with cerebral infarction or intracerebral hemorrhage confirmed by magnetic resonance imaging or computed tomography
- Persons for whom at least 1 month has elapsed since the diagnosis of stroke
- Persons showing a spastic hemiplegic gait pattern due to stroke
- Patients with a Functional Ambulatory Category score below 4
- Persons who can sit without assistance at the edge of a bed and can stand for 10 seconds with or without assistance
- Persons with sufficient cognitive ability to follow simple instructions and understand the content and purpose of the study (Mini-Mental State Examination score >= 20)
Who cannot join
- Persons with contraindications to lower-extremity weight bearing, such as severe lower-extremity joint contracture or an untreated fracture
- Persons for whom wearing the device is difficult due to skin disease or open wounds
- Persons with a severe difference in the length of the two lower extremities
- Persons with severe deformity or joint contracture in the lower extremities
- Persons unable to maintain a sitting posture or a standing posture on their own
- Persons with severe lower-extremity spasticity (Modified Ashworth Scale (MAS) grade 2 or higher)
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- Persons who cannot cooperate with gait therapy using the robot-assisted orthopedic exercise device due to severe cognitive decline (Mini-Mental State Examination score < 20), delirium, or severe language function impairment
- Persons who cannot maintain prolonged standing or walking due to underlying conditions such as orthostatic hypotension or reduced cardiopulmonary function
- Persons with other concomitant conditions affecting gait, such as peripheral neuropathy or parkinsonism due to alcoholism or severe diabetes
- Pregnant women or patients with the possibility of pregnancy
- Persons currently participating in another clinical trial
- Persons at high risk in the event of a fall or bleeding due to a coagulation disorder or the like
- Persons with a height less than 140 cm or greater than 190 cm
- Persons for whom wearing the robot is not possible
- Persons with clinically significant findings that, in the medical judgment of the principal investigator or a sub-investigator, are considered inappropriate for this study other than the above
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Yongin Severance Hospital
Yongin-si, Gyeonggi-do, 16995
Na Young Kim, MD, PhD, +82 010 9127 4482, kny8452@yuhs.ac
Seung Ick Choi, +82 010 8821 5297, rehab1@yuhs.ac
About this study
Official title: A Study to Evaluate the Effectiveness and Safety of At-Home Rehabilitation Gait Training Using a Hip-assisted Wearable Robot in Stroke Patients: An Investigator-Initiated, Single-Center, Single-Arm Exploratory Trial
The goal of this clinical trial is to learn whether a wearable monitoring system can help adults who have had a stroke get more out of a home exercise program. The system tracks how participants walk and move, then gives them feedback. Researchers want to know if this feedback improves walking, thinking and memory, and daily activity.
The wearable monitoring system has three parts:
Read more
A shoe insole sensor that measures how a person walks A wrist band that tracks daily activity, like a fitness watch A mobile app that gives feedback and lets participants report how they feel
The main questions this study aims to answer are:
Does feedback from the wearable system improve physical function, thinking and memory, and daily activity during a home exercise program? How satisfied are participants with using the wearable system?
Researchers will compare two groups. Both groups do the same home exercise program for 6 weeks. One group uses the wearable system and gets feedback. The other group does the program without the wearable system or feedback. This comparison shows whether the feedback itself makes a difference.
Who can take part: adults who have had a stroke and [key eligibility in plain words, e.g., "can walk a short distance with or without help"]. The study plans to enroll about [number] participants.
Participants in the wearable group will:
Get an insole sensor, a wrist activity tracker, and access to a mobile app Learn a home exercise program from the study team Wear the insole sensor and activity tracker while exercising at home for 6 weeks Use the app to see their feedback and report daily health information Complete a survey about their experience at the end
Participants in the comparison group will:
Do the same home exercise program for 6 weeks, without the wearable system or feedback.
Read the detailed description
After obtaining written consent, a screening test is performed. In the screening test, after taking a history of the subject's baseline symptoms and signs, the past history and medication history are confirmed, vital signs are measured, and a physical examination is conducted, and the overall gait status such as whether assistive devices are used during gait and the gait pattern is assessed. Subjects who pass the screening test undergo the initial assessment within 7 days.
The initial assessment is conducted including the 2-Minute Walk Test, spatiotemporal gait parameters, the Berg Balance Scale, and subjects who complete the initial assessment begin robot-assisted gait training on the same day.
After the initial assessment, gait training using the hip-assisted wearable robot is performed in the home or an indoor space near the home twice a week for 2 weeks, a total of 4 times, for 30 minutes each. The interval between each intervention visit is set not to exceed 5 days.
After the end of the 2 weeks of robot-assisted gait training, on the day of completion, the end-of-study assessment is performed identically to the initial assessment, and a satisfaction assessment for the hip-assisted wearable robot is conducted.
In addition, when a device abnormality occurs, measures are taken and the relevant details are recorded, the usability of the hip-assisted wearable robot is analyzed, the gait and balance function assessment results in the non-wearing/wearing states of the hip-assisted wearable robot are statistically compared before and after gait training, and the burden and satisfaction assessments of the hip-assisted wearable robot are analyzed.
- Conditions
- Stroke
- Being tested
- hip-assisted wearable robot
- Keywords
- Home-based rehabilitation, Robot-assisted gait training, Telehealth, Exoskeleton Device, Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hip-assisted wearable robotDevice
A hip-assisted wearable robot (wearable gait-assist robot) that assists flexion and extension of the hip joint during walking. The battery-powered device is controlled through a paired mobile application via Bluetooth, and its assistive force can be adjusted to each participant. A visiting physical or occupational therapist applies the device and delivers gait training at the participant's home for 4 sessions over 2 weeks, 30 minutes per session, under a physician's prescription and supervision.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (Home-based Robot-assisted Gait training group) | Experimental | Participants receive home-based robot-assisted gait training using a hip-assisted wearable robot. A visiting physical or occupational therapist delivers the training at the participant's home for 4 sessions over 2 weeks, 30 minutes per session, under a physician's prescription and supervision. Receives: Device: hip-assisted wearable robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Telehealth Usability Questionnaire (TUQ)
Usability of the home-based robot-assisted gait rehabilitation service, measured with a questionnaire based on the Telehealth Usability Questionnaire (TUQ). Items are rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree); higher scores indicate better usability. Total and item scores are summarized.
Measured: At the end of the 2-week intervention (after session 4)
Secondary outcomes (8)
Distance of 2-Minute Walk Test (2MWT)
Patients are instructed to walk back as many times as possible within 2 minutes. The examiner records the total distance covered, abnormal gait patterns, and the time of occurrence of any gait deviations.
Measured: Baseline (Day 1) and end of the 2-week intervention (Week 2, after session 4)
Spatiotemporal Parameters of Gait: Cadence
While the participant performs the test wearing an insole-type gait analyzer, spatiotemporal gait parameters are collected and recorded. Cadence: The number of steps taken per minute, measured in steps per minute (spm).
Measured: Baseline (Day 1) and end of the 2-week intervention (Week 2, after session 4)
Spatiotemporal Parameters of Gait : Total Step Count
While the participant performs the test wearing an insole-type gait analyzer, spatiotemporal gait parameters are collected and recorded. Total Step Count: The total number of steps taken during walking.
Measured: Baseline (Day 1) and end of the 2-week intervention (Week 2, after session 4)
Spatiotemporal Parameters of Gait : Self-Selected Walking Speed
While the participant performs the test wearing an insole-type gait analyzer, spatiotemporal gait parameters are collected and recorded. Self-Selected Walking Speed: The participant's walking speed when walking naturally at a comfortable pace.
Measured: Baseline (Day 1) and end of the 2-week intervention (Week 2, after session 4)
Spatiotemporal Parameters of Gait : Distance
While the participant performs the test wearing an insole-type gait analyzer, spatiotemporal gait parameters are collected and recorded. Distance: The total distance covered during walking, measured in meters (m).
Measured: Baseline (Day 1) and end of the 2-week intervention (Week 2, after session 4)
Spatiotemporal Parameters of Gait : Stride Length
While the participant performs the test wearing an insole-type gait analyzer, spatiotemporal gait parameters are collected and recorded. Stride Length: The distance between the heel of one foot to the heel of the same foot during consecutive steps. Measured in meters (m), stride length is adjusted for height to account for differences in body size.
Measured: Baseline (Day 1) and end of the 2-week intervention (Week 2, after session 4)
Berg Balance Scale (BBS)
Patients are asked to perform 14 tasks regarding the static and dynamic balance of patients. Each task was rated on a five-point scale from 0 to 4, with a total score of 56.
Measured: Baseline (Day 1) and end of the 2-week intervention (Week 2, after session 4)
Participant Satisfaction (K-QUEST 2.0-based)
Satisfaction with the device and home-based service, measured with the 12-item, 5-point Korean version of the Quebec User Evaluation of Satisfaction with Assistive Technology (K-QUEST 2.0). Each item is scored from 1 to 5, and the total score is the sum of the 12 items, ranging from a minimum of 12 to a maximum of 60. Higher scores indicate greater satisfaction.
Measured: At the end of the 2-week intervention (after session 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start6 Jul 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants receive the same intervention: home-based robot-assisted gait training. There is no control group.
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Health Industry Development Institute
- Responsible party
- Principal investigator, Na Young Kim, Severance Hospital
- Investigators
- Na Young Kim, MD, PhD, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07716475
- Sponsor's protocol ID
- 9-2026-0096
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee S-H, Jung B-K, Park S-Y. Korean translation and psychometric properties of Quebec user evaluation of satisfaction assistive technology 2.0. Journal of the Korea Academia-Industrial Cooperation Society 2013;14:3284-3292
Lee MH, Tian MY, Kim MK. The Effectiveness of Overground Robot Exoskeleton Gait Training on Gait Outcomes, Balance, and Motor Function in Patients with Stroke: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Brain Sci. 2024 Aug 19;14(8):834. doi: 10.3390/brainsci14080834.
PubMed 39199525Bang DH, Shin WS. Effects of robot-assisted gait training on spatiotemporal gait parameters and balance in patients with chronic stroke: A randomized controlled pilot trial. NeuroRehabilitation. 2016 Apr 6;38(4):343-9. doi: 10.3233/NRE-161325.
PubMed 27061162Godi M, Franchignoni F, Caligari M, Giordano A, Turcato AM, Nardone A. Comparison of reliability, validity, and responsiveness of the mini-BESTest and Berg Balance Scale in patients with balance disorders. Phys Ther. 2013 Feb;93(2):158-67. doi: 10.2522/ptj.20120171. Epub 2012 Sep 27.
PubMed 23023812Kosak M, Smith T. Comparison of the 2-, 6-, and 12-minute walk tests in patients with stroke. J Rehabil Res Dev. 2005 Jan-Feb;42(1):103-7. doi: 10.1682/jrrd.2003.11.0171.
PubMed 15742254Parmanto B, Lewis AN Jr, Graham KM, Bertolet MH. Development of the Telehealth Usability Questionnaire (TUQ). Int J Telerehabil. 2016 Jul 1;8(1):3-10. doi: 10.5195/ijt.2016.6196. eCollection 2016 Spring.
PubMed 27563386Zimmermann J, Morf H, Scharf F, Knitza J, Moeller H, Muehlensiepen F, Nathrath M, Orlemann T, Voelker T, Deckers M. German Version of the Telehealth Usability Questionnaire and Derived Short Questionnaires for Usability and Perceived Usefulness in Health Care Assessment in Telehealth and Digital Therapeutics: Instrument Validation Study. JMIR Hum Factors. 2024 Nov 21;11:e57771. doi: 10.2196/57771.
PubMed 39571151Kang YW, Na DL, Hahn SH. A validity study on the Korean Mini-Mental State Examination (K-MMSE) in dementia patients. J Korean Neurol Assoc. 1997;15(2):300-308.5
Mehrholz J, Wagner K, Rutte K, Meissner D, Pohl M. Predictive validity and responsiveness of the functional ambulation category in hemiparetic patients after stroke. Arch Phys Med Rehabil. 2007 Oct;88(10):1314-9. doi: 10.1016/j.apmr.2007.06.764.
PubMed 17908575Gregson JM, Leathley M, Moore AP, Sharma AK, Smith TL, Watkins CL. Reliability of the Tone Assessment Scale and the modified Ashworth scale as clinical tools for assessing poststroke spasticity. Arch Phys Med Rehabil. 1999 Sep;80(9):1013-6. doi: 10.1016/s0003-9993(99)90053-9.
PubMed 10489001Gajdosik RL, Bohannon RW. Clinical measurement of range of motion. Review of goniometry emphasizing reliability and validity. Phys Ther. 1987 Dec;67(12):1867-72. doi: 10.1093/ptj/67.12.1867.
PubMed 3685114Chin LF, Lim WS, Kong KH. Evaluation of robotic-assisted locomotor training outcomes at a rehabilitation centre in Singapore. Singapore Med J. 2010 Sep;51(9):709-15.
PubMed 20938611De Luca R, Maresca G, Balletta T, Cannavo A, Leonardi S, Latella D, Maggio MG, Portaro S, Naro A, Calabro RS. Does overground robotic gait training improve non-motor outcomes in patients with chronic stroke? Findings from a pilot study. J Clin Neurosci. 2020 Nov;81:240-245. doi: 10.1016/j.jocn.2020.09.070. Epub 2020 Oct 15.
PubMed 33222923Chou CH, Hwang CL, Wu YT. Effect of exercise on physical function, daily living activities, and quality of life in the frail older adults: a meta-analysis. Arch Phys Med Rehabil. 2012 Feb;93(2):237-44. doi: 10.1016/j.apmr.2011.08.042.
PubMed 22289232Lange AK, Vanwanseele B, Fiatarone Singh MA. Strength training for treatment of osteoarthritis of the knee: a systematic review. Arthritis Rheum. 2008 Oct 15;59(10):1488-94. doi: 10.1002/art.24118.
PubMed 18821647