Effectiveness and Safety of At-home Gait Rehabilitation Using Wearable Exoskeletal Robot
NCT Number: NCT06543758
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Stroke|Gait, Spastic|Gait, Hemiplegic
Interventions: DEVICE: Wearable exoskeletal robot
Sponsor: Yonsei University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 16
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2026-07-31
Locations: Yongin Severance Hospital, Yongin-si, Gyeonggi-do, 16995, Korea, Republic of

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.

Primary Outcome Measures: 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 Outcome Measures: 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., 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), 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, 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, 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), 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, 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, 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.