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

NCT06543758 | Recruiting Phase 4

• 1 other identifier: 9-2024-0111
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke; Gait, Spastic; Gait, Hemiplegic

Keywords

Wearable robot; Exoskeletal robot; At-home rehabilitation; Gait rehabilitation; Stroke

Outcome Measures

Primary Outcomes (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).

  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)

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

  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)

  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

  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

  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)

  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.

Study Arms (1)

Wearable exoskeletal robot group

EXPERIMENTAL

Patients with stroke receive home-based robotic-assisted gait rehabilitation using a wearable exoskeletal robot.

Device: Wearable exoskeletal robot

Interventions

Wearable exoskeletal robot DEVICE

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.

Wearable exoskeletal robot group

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yongin Severance Hospital

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

RECRUITING

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MeSH Terms

Conditions

Stroke; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: August 9, 2024
• Study Start: August 1, 2024
• Primary Completion: July 31, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)