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

November 14, 2024 updated by: Yonsei University

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:

  • 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

16

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Na Young Kim, MD, PhD
  • Phone Number: +82 010 9127 4482
  • Email: kny8452@yuhs.ac

Study Contact Backup

  • Name: Seung Ick Choi
  • Phone Number: +82 010 8821 5297
  • Email: rehab1@yuhs.ac

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Yongin-si, Gyeonggi-do, Korea, Republic of, 16995
        • Recruiting
        • Yongin Severance Hospital
        • Contact:
          • Seung Ick Choi
          • Phone Number: +82 010 8821 5297
          • Email: rehab1@yuhs.ac
        • Contact:
        • Principal Investigator:
          • Na Young Kim, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. adults aged 19 to 79 years (based on the age on their national ID at the time of consent)
  2. individuals diagnosed with cerebral infarction or intracerebral hemorrhage confirmed by MRI or CT.
  3. patients who have passed at least one month since stroke diagnosis.
  4. individuals exhibiting spastic hemiplegic gait patterns due to stroke.
  5. patients with a Functional Ambulatory Category score of less than 4.
  6. individuals who can sit on the edge of a bed without assistance and stand for 10 seconds with or without assistance.
  7. individuals with sufficient cognitive ability to follow simple instructions and understand the study's content and purpose (Mini-Mental State Examination score >= 20)

Exclusion Criteria:

  1. individuals with severe joint contractures or osteoporosis, or untreated fractures that contraindicate weight-bearing on the lower limbs.
  2. individuals with skin conditions or open wounds that prevent device usage.
  3. individuals with significant differences in leg length.
  4. individuals with severe deformities or joint contractures in the lower limbs.
  5. individuals at high risk of fractures due to conditions like osteoporosis.
  6. individuals unable to maintain a sitting or standing position independently.
  7. individuals with severe lower limb spasticity (Modified Ashworth Scale grade 2 or higher).
  8. 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.
  9. individuals unable to maintain prolonged standing or walking due to conditions like orthostatic hypotension or cardiopulmonary impairment.
  10. individuals with conditions affecting gait, such as peripheral neuropathy, Parkinsonism, or those with alcohol dependence or severe diabetes.
  11. pregnant women or those who could become pregnant.
  12. individuals participating in other clinical trials.
  13. individuals at high risk of falls or bleeding due to conditions like coagulopathies.
  14. individuals shorter than 140 cm, taller than 190 cm, or weighing over 80 kg.
  15. individuals with other clinical findings deemed inappropriate for the study by the principal investigator or study coordinator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Wearable exoskeletal robot group
Patients with stroke receive home-based robotic-assisted gait rehabilitation using a wearable exoskeletal robot.
Device: Wearable exoskeletal robot
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related quality of life measurement (36-item Short Form Survey Instrument, SF-36)
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.
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.
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.
Beck depression inventory (BDI)
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.
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.
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.
Body composition analysis
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.

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.
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.
Spatiotemporal parameters of walking
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.
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 (%).
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.
Timed up and go test (TUG)
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.

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.
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.
Berg Balance Scale
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.
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.
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.
Satisfaction evaluation
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.
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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Na Young Kim, MD, PhD, Severance Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

July 24, 2024

First Submitted That Met QC Criteria

August 5, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Estimated)

November 19, 2024

Last Update Submitted That Met QC Criteria

November 14, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9-2024-0111

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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