Augmented Reality for Stroke Rehabilitation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Fugl-Meyer Assessment Upper Extremity and Lower Extremity (FMA-UE and FMA-LE);
Study Overview
Brief Summary
The study aims to determine the effectiveness of Augmented reality on motor function, balance, and functional ambulation in stroke patients.
Detailed Description
The study aims to determine the effectiveness of Augmented reality on motor function, balance, and functional ambulation in stroke patients. The emerging technology of Augmented Reality (AR), has been validated as a promising way to assist the rehabilitation training in Stroke patients. The purpose of this study is to investigate the feasibility of the AR rehabilitation system in a real-world setting. The following questions will be addressed by the present study: (a) How the Augmented reality effects motor function, balance, and functional ambulation in stroke patients? (b) how much and what types of manpower can be saved while maintaining the efficacy of training with the assistance of the AR rehabilitation? (c) how can the contact rate be reduced with the AR training? (d) how do therapists/patients experience the AR training?
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants falling in this category would be recruited into the study.
- •age between 18 to 90 years who are diagnosed with ischemic brain injury, intracerebral hemorrhage shown by magnetic resonance imaging, or computed tomography after the onset of stroke;
- •with motor impairment in the upper limb, lower limb, and/or balance;
- •have no or mild spasticity on the lower limb or upper limb assessed by Modified Ashworth Scale (MAS ≤ 2); and
- •have sufficient cognition to follow the instructions provided by the therapists and the computer.
Exclusion Criteria
- •Participants fall in this category would be excluded of the study.
- •any additional medical or psychological condition that would affect their ability to comply with the study protocol, e.g., a significant orthopedic or chronic pain condition, major post-stroke depression, epilepsy, artificial cardiac pacemaker/joint;
- •have severe shoulder/arm or hip/knee contracture/ pain and;
- •Pregnant women.
Arms & Interventions
Traditional Treatment
Task based training to the Control Group
Intervention: Traditional Training (Other)
Augmented Reality Training
Augmented reality training to Experimental group
Intervention: Augmented Reality (Other)
Outcomes
Primary Outcomes
Fugl-Meyer Assessment Upper Extremity and Lower Extremity (FMA-UE and FMA-LE);
Time Frame: 10 weeks
The cumulative test score for all components is 226 with availability of specific subtest scores (e.g., UE maximum score is 66, LE score 34; balance score 14). This instrument has good construct validity and high reliability (r 0.99) for determining motor function.
Berg Balance Scale (BBS);
Time Frame: 10 weeks
The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete.
Functional Ambulation Category (FAC)
Time Frame: 10 weeks
The Functional Ambulation Categories (FAC) is a 6-point functional walking test that evaluates ambulation ability, determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device. The FAC is a quick visual measurement of walking, is simple to use, easy to interpret. The test has good interrater reliability (κ=.72) and excellent test-retest reliability (k=.950).
Secondary Outcomes
- Quality of life (QOL): physical and mental health using the 12-Item Short Form Health Survey (SF 12v2)(10 weeks)
- User experience (UX) using questionnaires (designed based on UEQ-S)(10 weeks)
- Activities of Daily Living (ADL) using the Barthel Index (BI)(10 weeks)