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

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

Overview

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.

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.

Interventions

• Device hip-assisted wearable robot
  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.

Primary outcome measures

• Telehealth Usability Questionnaire (TUQ) [Time frame: At the end of the 2-week intervention (after session 4)]

Secondary outcome measures (8)

• Distance of 2-Minute Walk Test (2MWT) [Time frame: Baseline (Day 1) and end of the 2-week intervention (Week 2, after session 4)]
• Spatiotemporal Parameters of Gait: Cadence [Time frame: Baseline (Day 1) and end of the 2-week intervention (Week 2, after session 4)]
• Spatiotemporal Parameters of Gait : Total Step Count [Time frame: Baseline (Day 1) and end of the 2-week intervention (Week 2, after session 4)]
• Spatiotemporal Parameters of Gait : Self-Selected Walking Speed [Time frame: Baseline (Day 1) and end of the 2-week intervention (Week 2, after session 4)]
• Spatiotemporal Parameters of Gait : Distance [Time frame: Baseline (Day 1) and end of the 2-week intervention (Week 2, after session 4)]
• Spatiotemporal Parameters of Gait : Stride Length [Time frame: Baseline (Day 1) and end of the 2-week intervention (Week 2, after session 4)]
• Berg Balance Scale (BBS) [Time frame: Baseline (Day 1) and end of the 2-week intervention (Week 2, after session 4)]
• Participant Satisfaction (K-QUEST 2.0-based) [Time frame: At the end of the 2-week intervention (after session 4)]

Eligibility criteria

Inclusion criteria

• 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)

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Health services research

Study locations

South Korea · 1 center

• Yongin Severance Hospital — Yongin-si

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. PMID 39199525
• 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
• Godi 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. PMID 23023812
• Kosak 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. PMID 15742254
• 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
• 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
• Kang 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

Identifiers

NCT: NCT07716475 · 9-2026-0096

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗