Evaluate the Effectiveness and Safety of At-Home Rehabilitation Gait Training Using a Hip-assisted Wearable Robot in Stroke Patients

NCT07716475 | Recruiting

• 1 other identifier: 9-2026-0096
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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. Researchers want to know if this feedback improves walking, thinking and memory, and daily activity. The wearable monitoring system has three parts: 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.

Conditions

Stroke

Keywords

Home-based rehabilitation; Robot-assisted gait training; Telehealth; Exoskeleton Device; Stroke

Outcome Measures

Primary Outcomes (1)

• 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.

  At the end of the 2-week intervention (after session 4)

Secondary Outcomes (8)

• Distance of 2-Minute Walk Test (2MWT)

  Baseline (Day 1) and end of the 2-week intervention (Week 2, after session 4)

• Spatiotemporal Parameters of Gait: Cadence

  Baseline (Day 1) and end of the 2-week intervention (Week 2, after session 4)

• Spatiotemporal Parameters of Gait : Total Step Count

  Baseline (Day 1) and end of the 2-week intervention (Week 2, after session 4)

• Spatiotemporal Parameters of Gait : Self-Selected Walking Speed

  Baseline (Day 1) and end of the 2-week intervention (Week 2, after session 4)

• Spatiotemporal Parameters of Gait : Distance

  Baseline (Day 1) and end of the 2-week intervention (Week 2, after session 4)

Study Arms (1)

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.

Device: hip-assisted wearable robot

Interventions

hip-assisted wearable robot DEVICE

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.

Intervention group (Home-based Robot-assisted Gait training group)

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Yonsei University: lead
• Korea Health Industry Development Institute: collaborator

Study Sites (1)

Yongin Severance Hospital

Yongin-si, Gyeonggi-do, 16995, South Korea

RECRUITING

Related Publications (17)

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  BACKGROUND

• 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.

  PMID: 39199525 BACKGROUND

• Bang 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.

  PMID: 27061162 BACKGROUND

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  PMID: 23023812 BACKGROUND

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  PMID: 15742254 BACKGROUND

• Parmanto 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.

  PMID: 27563386 BACKGROUND

• Zimmermann 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.

  PMID: 39571151 BACKGROUND

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  BACKGROUND

• 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.

  PMID: 17908575 BACKGROUND

• Gregson 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.

  PMID: 10489001 BACKGROUND

• Gajdosik 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.

  PMID: 3685114 BACKGROUND

• Chin 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.

  PMID: 20938611 BACKGROUND

• De 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.

  PMID: 33222923 BACKGROUND

• Chou 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.

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  PMID: 20590073 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Na Young Kim, MD, PhD

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Na Young Kim, MD, PhD

CONTACT

+82 010 9127 4482; kny8452@yuhs.ac

Seung Ick Choi

CONTACT

+82 010 8821 5297; rehab1@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: All participants receive the same intervention: home-based robot-assisted gait training. There is no control group.

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 21, 2026
• Study Start: July 6, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): July 30, 2027
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)