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StrokePhase 4NCT06543758

Effectiveness and Safety of At-home Gait Rehabilitation Using Wearable Exoskeletal Robot

A Phase 4 study testing Wearable exoskeletal robot in people with Stroke and Gait, Spastic, run by Yonsei University at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 19 to 79 years
Conditions the study is for
Stroke, Gait, Spastic, Gait, Hemiplegic
What is being tested?
Wearable exoskeletal robot
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
1 Aug 2024to 31 Jul 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

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 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • individuals with severe joint contractures or osteoporosis, or untreated fractures that contraindicate weight-bearing on the lower limbs.
  • individuals with skin conditions or open wounds that prevent device usage.
  • individuals with significant differences in leg length.
  • individuals with severe deformities or joint contractures in the lower limbs.
  • individuals at high risk of fractures due to conditions like osteoporosis.
  • individuals unable to maintain a sitting or standing position independently.
Show all 15Show fewer
  • individuals with severe lower limb spasticity (Modified Ashworth Scale grade 2 or higher).
  • 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.
  • pregnant women or those who could become pregnant.
  • individuals participating in other clinical trials.
  • individuals at high risk of falls or bleeding due to conditions like coagulopathies.
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Na Young Kim, MD, PhD contact

+82 010 9127 4482

kny8452@yuhs.ac

Seung Ick Choi contact

+82 010 8821 5297

rehab1@yuhs.ac

South Korea1 site, 1 recruiting

  • Yongin Severance Hospital

    Yongin-si, Gyeonggi-do, 16995

    Na Young Kim, +82 010 9127 4482, kny8452@yuhs.ac

    Seung Ick Choi, +82 010 8821 5297, rehab1@yuhs.ac

    Recruiting

Other trials in South Korea

About this study

Official title: 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

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:

Read more
  • 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.
Read the detailed description

After obtaining informed consent, a screening test is conducted. The screening test includes a review of the participant's baseline symptoms and signs, medical history, and medication usage, followed by a physical examination and assessment of gait status, including the use of assistive devices and gait patterns. Participants who pass the screening test undergo an initial assessment within seven days.

The initial assessment includes physical function tests such as the 10-meter walk test, the Timed Up and Go (TUG) test, and the Berg Balance Scale, along with quality of life and Beck Depression Inventory assessments. Participants who complete the initial assessment begin robotic-assisted gait training within two days.

The training is conducted using a wearable exoskeletal robot for gait training at home or in nearby indoor spaces. The training lasts for four weeks, with sessions held 2-3 times per week, totaling 10 sessions, each lasting 30 minutes.

After four weeks, the robotic-assisted gait training concludes, and within two days, an endpoint assessment identical to the initial assessment is performed. Satisfaction with the wearable exoskeletal robot is also evaluated.

Any device malfunctions are addressed and documented. The usage and satisfaction levels of the wearable exoskeletal robot are analyzed, and pre- and post-training assessment metrics are compared.

Being tested
Wearable exoskeletal robot
Keywords
Wearable robot, Exoskeletal robot, At-home rehabilitation, Gait rehabilitation, Stroke
Medical subject headings
Stroke, Gait Disorders, Neurologic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Wearable exoskeletal robotDevice

    Participants will wear a wearable exoskeletal robot for gait training and undergo 10 sessions of 30-minute gait training over 4 weeks at home or in nearby indoor spaces. Participants will participate in physical function assessments, including the 10-meter walk test, Timed Up and Go (TUG) test, and Berg Balance Scale, both before and after the intervention. Additionally, participants will complete quality of life and depression inventories before and after the intervention.

Study groups in NCT06543758
Study groupRoleWhat they receive
Wearable exoskeletal robot groupExperimentalPatients with stroke receive home-based robotic-assisted gait rehabilitation using a wearable exoskeletal robot.
Receives: Device: Wearable exoskeletal robot

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 10MWT (10 meter walk test)

    A simple and effective clinical evaluation method used to measure the walking speed of participants, useful for assessing functional recovery and changes in gait ability. The measurement method involves timing how long it takes to walk 10 meters, then dividing 10 by the time taken to record the walking speed (m/s).

    Measured: This session will be performed at baseline and after the intervention. A baseline assessment will be conducted within 2 days before the robotic-assisted gait training, and an end-point assessment will be conducted within 2 days after the gait training.

Secondary outcomes (7)

  1. Health-related quality of life measurement (36-item Short Form Survey Instrument, SF-36)

    A self-reported survey consisting of 36 items used to assess participants' overall health-related quality of life. The evaluation tool measures satisfaction with overall health, with scores ranging from 0 to 100.

    Measured: This session will be performed at baseline and after the intervention. A baseline assessment will be conducted within 2 days before the robotic-assisted gait training, and an end-point assessment will be conducted within 2 days after the gait training.

  2. Beck depression inventory (BDI)

    An evaluation tool designed based on clinical depressive symptoms. It consists of 21 self-reported items where patients check and record their scores in areas such as affective cognition and motivation. Scores range from 0 to 63.

    Measured: This session will be performed at baseline and after the intervention. A baseline assessment will be conducted within 2 days before the robotic-assisted gait training, and an end-point assessment will be conducted within 2 days after the gait training.

  3. Body composition analysis

    This is a test performed to check the subject's limb muscle mass, and the test method is as follows.

    • Perform body composition analysis17 based on bioimpedance analysis.
    • To ensure accurate measurement, the test subject is instructed to empty his/her bladder before the test and not to consume caffeinated beverages, eat, drink, or perform strenuous exercise for one hour prior to the test.
    • To correct for muscle mass differences due to height, use the calculated value of limb muscle mass (Appendicular skeletal mass) divided by the square of the height.

    Measured: This session will be performed at baseline and after the intervention. A baseline assessment will be conducted within 2 days before the robotic-assisted gait training, and an end-point assessment will be conducted within 2 days after the gait training.

  4. Spatiotemporal parameters of walking

    Spatiotemporal parametric data of gait collected while the subject is performing a home-based activity wearing an insole gait analyzer, recording total steps, steps per minute, gait speed (km/h), distance walked (m), stride length (m), and swing phase rate (%).

    Measured: This session will be performed at baseline and after the intervention. A baseline assessment will be conducted within 2 days before the robotic-assisted gait training, and an end-point assessment will be conducted within 2 days after the gait training.

  5. Timed up and go test (TUG)

    The above test assesses walking speed along with balance ability during walking18, and this is performed as follows.

    • A 46 cm high armrest chair, a color cone is placed at a distance of 3 meters from the chair and the subject is instructed to sit on the chair.
    • In the preparation phase, the subject leans against the chair backrest and places his/her arms on the armrests, then stands up on the instruction "Start", walks 3 meters, turns around the color cone, returns to the starting point and sits down on the chair.

    Measured: This session will be performed at baseline and after the intervention. A baseline assessment will be conducted within 2 days before the robotic-assisted gait training, and an end-point assessment will be conducted within 2 days after the gait training.

  6. Berg Balance Scale

    The following tests evaluate static and dynamic balance,19 and have been used in previous studies to assess progress after robotic-assisted gait therapy.20 The examiner instructs the participant to perform the following 14 tasks and evaluates them according to specific criteria. Scores range from 0 to 56.

    Measured: This session will be performed at baseline and after the intervention. A baseline assessment will be conducted within 2 days before the robotic-assisted gait training, and an end-point assessment will be conducted within 2 days after the gait training.

  7. Satisfaction evaluation

    Participants will complete a satisfaction survey for the home-based rehabilitation service using the wearable exoskeletal robot, based on the Korean version of the Quebec User Evaluation of Satisfaction with assistive Technology (K-QUEST 2.0).21 This survey consists of 12 items on a 5-point scale. Participants rate their satisfaction with the assistive device and related services

    Measured: This session will be performed at baseline and after the intervention. A baseline assessment will be conducted within 2 days before the robotic-assisted gait training, and an end-point assessment will be conducted within 2 days after the gait training.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2024
  2. Study start1 Aug 2024
  3. Primary completion31 Jul 2025 (estimated)
  4. Study completion31 Jul 2026 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Researchers will compare pre- and post-intervention walking speeds, body composition, spatiotemporal parameters, balance, and satisfaction survey in participants and does not establish a control group.
Masking
None (open label)
Enrolment
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06543758
Sponsor's protocol ID
9-2024-0111
Status last verified
Nov 2024
First submitted
24 Jul 2024
Last updated
19 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Salzman B. Gait and balance disorders in older adults. Am Fam Physician. 2010 Jul 1;82(1):61-8.

    PubMed 20590073

  • Bennett DA, Beckett LA, Murray AM, Shannon KM, Goetz CG, Pilgrim DM, Evans DA. Prevalence of parkinsonian signs and associated mortality in a community population of older people. N Engl J Med. 1996 Jan 11;334(2):71-6. doi: 10.1056/NEJM199601113340202.

    PubMed 8531961

  • Lange 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

  • 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.

    PubMed 22289232

  • 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.

    PubMed 33222923

  • 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.

    PubMed 20938611

  • Schwartz I, Meiner Z. Robotic-assisted gait training in neurological patients: who may benefit? Ann Biomed Eng. 2015 May;43(5):1260-9. doi: 10.1007/s10439-015-1283-x. Epub 2015 Feb 28.

    PubMed 25724733

  • 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.

    PubMed 3685114

  • 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.

    PubMed 10489001

  • 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 17908575

  • Tombaugh TN, McIntyre NJ. The mini-mental state examination: a comprehensive review. J Am Geriatr Soc. 1992 Sep;40(9):922-35. doi: 10.1111/j.1532-5415.1992.tb01992.x.

    PubMed 1512391

  • Plank LD. Dual-energy X-ray absorptiometry and body composition. Curr Opin Clin Nutr Metab Care. 2005 May;8(3):305-9. doi: 10.1097/01.mco.0000165010.31826.3d.

    PubMed 15809534

  • Rachner TD, Khosla S, Hofbauer LC. Osteoporosis: now and the future. Lancet. 2011 Apr 9;377(9773):1276-87. doi: 10.1016/S0140-6736(10)62349-5. Epub 2011 Mar 28.

    PubMed 21450337

  • Chard T. Pregnancy tests: a review. Hum Reprod. 1992 May;7(5):701-10. doi: 10.1093/oxfordjournals.humrep.a137722.

    PubMed 1639991

  • Anderson C, Laubscher S, Burns R. Validation of the Short Form 36 (SF-36) health survey questionnaire among stroke patients. Stroke. 1996 Oct;27(10):1812-6. doi: 10.1161/01.str.27.10.1812.

    PubMed 8841336

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Wearable exoskeletal robot in people with Stroke and Gait, Spastic, run by Yonsei University 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 7 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 19 Nov 2024. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Na Young Kim, MD, PhD (+82 010 9127 4482, kny8452@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

10MWT (10 meter walk test) (time frame: This session will be performed at baseline and after the intervention. A baseline assessment will be conducted within 2 days before the robotic-assisted gait training, and an end-point assessment will be conducted within 2 days after the gait training.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06543758, which also lists 22 linked publications.

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 19 Nov 2024.

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