The Effects of Robot-Assisted Gait Training Concurrent With Self-Observation Training on Balance, Gait, Cognitive Function in Stroke
| Registry | NCT06476327 |
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 20 (Estimated) |
| Sponsor | Sahmyook University (Other) |
| Conditions | Stroke |
| Interventions | experimental 1 group, experimental 2 group (Behavioral) |
| Dates | start 2024-07-01 (estimated), primary completion 2024-07-01 (estimated), completion 2024-10-01 (estimated), first posted 2024-06-26, last updated 2024-07-01 |
| Locations | 1 site in South Korea |
Related Papers Related Patents Related Grants Related Experts
All trials for Stroke All trials of experimental 1 group All trials of experimental 2 group
-Summary
The aim of this study is to investigate the effects of robot-assisted gait training Concurrent with self-observation training on balance, gait, and cognitive function in stroke participants. The main question it aims to answer is:
Does robot-assisted gait training combined with self-observation improve balance abilities in stroke participants?
Participants will be
Group 1 Perform robot-assisted gait training combined with self-observation five times a week for four weeks.
Group 2 Perform robot-assisted gait training five times a week for four weeks.
All groups perform for 30 minutes per session.
Expand all sections · Collapse all
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| experimental 1 group | Active comparator | Behavioral: experimental 1 group | Robot-Assisted Gait with Self-Observation |
| experimental 2 group | Active comparator | Behavioral: experimental 2 group | Robot-Assisted Gait |
- experimental 1 group (Behavioral): A camera is installed on the walker used in the training, and the recorded video is mirrored in real-time to a tablet computer. Participants can view this video through smart glasses connected to the tablet computer. A glasses strap will be used to secure the glasses, ensuring there is no interference with walking.
Participants will undergo a total of 20 training sessions, five times a week for four weeks, with each session lasting 30 minutes. Participants will have a 4-minute break during the 30-minute gait training session.
Participants will be given a period to adapt to wearing the robot, and after that, the intervention will be conducted based on each participant's individual abilities and adaptation.
- experimental 2 group (Behavioral): Participants will undergo a total of 20 training sessions, five times a week for four weeks, with each session lasting 30 minutes. Participants will have a 4-minute break during the 30-minute gait training session.
Participants will be given a period to adapt to wearing the robot, and after that, the intervention will be conducted based on each participant's individual abilities and adaptation.
+Outcome measures
Primary outcomes
- Balance ability [from enrollment to the end of treatment at 4 weeks]: \- Timed up and go test (TUG)
Participants sit on a chair with armrests, rise upon hearing a starting signal, walk 3 meters, return, and sit back down. The speed of this task is measured. Participants may use usual walking aids (cane or walker) but should not receive physical assistance.
\- Functional Reach Test (FRT)
Participants stand against a wall with feet fixed vertically, arms raised to 90 degrees, reaching forward as far as possible while measuring the distance (in cm) from the tip of the third metacarpal bone.
- Gait ability [from enrollment to the end of treatment at 4 weeks]: -10 meter walking test (10MWT)
The walking speed is calculated by measuring the time (in seconds) takes for the subject to walk 10 meters. Instructed to walk a total of 14 meters at maximum speed, excluding the first 2 meters and the last 2 meters to account for acceleration and deceleration phases. Participants may use personal walking aids (cane, walker, etc.).
-GAITRite system (CIR Systems Inc., Franklin, New Jersey, USA)
Participants pass over an electronic gait mat to computationally measure temporal and spatial walking variables.
Secondary outcomes
- Cognitive ability [from enrollment to the end of treatment at 4 weeks]: \- Mini-Mental Status Examination-Korea, (MMSE-K)
Consists of memory, recall ability, attention, language skills, numerical ability, and constructional ability.
Memory has 10 points, registration has 3 points, attention and calculation have 5 points, recall has 3 points, language function has 7 points, and comprehension and judgment have 2 points, totaling six areas and twelve items
+Eligibility
Sex: All, ages: 30 Years to 80 Years
Inclusion Criteria:
* Participants who have had a stroke for more than 6 months but less than 1 year
* Functional Ambulation Category (FAC) ≥ 2
* Able to walk 10 meters independently with or without an assistive device
* Participants eligible for application of the robot (ANGEL LEGS M20, Anger Robotics)
Exclusion Criteria:
* Inability to wear the robot due to open wounds or skin conditions
* Severe cognitive impairment (MMSE-K < 10) or significant difficulty in communication due to language disorders
* Spasticity of the paralyzed limb with a Modified Ashworth Scale (MAS) ≥ 2
* High risk of fractures, such as osteoporosis
* Severe cardiovascular or pulmonary diseases
* Neurological disorders affecting gait function, such as Parkinson's disease or multiple sclerosis
+Locations (1)
| Facility | City | Country | Status |
|---|
| Chungdam hospital | Seoul, Gangnam-gu | South Korea | |