Augmented Reality for Stroke Rehabilitation

Not Applicable

Recruiting

• Conditions: Stroke/Brain Attack

• Registration Number: NCT06761781
• Lead Sponsor: Riphah International University

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?

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2024-12-31
• Status Verified: 2025-01
• Study First Submitted: 2025-01-01
• Study First Submitted QC: 2025-01-06
• Last Update Submitted: 2025-01-06
• Study First Posted: 2025-01-07
• Last Update Posted: 2025-01-07
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Participants falling in this category would be recruited into the study.

1. 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;
2. with motor impairment in the upper limb, lower limb, and/or balance;
3. have no or mild spasticity on the lower limb or upper limb assessed by Modified Ashworth Scale (MAS ≤ 2); and
4. have sufficient cognition to follow the instructions provided by the therapists and the computer.

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Exclusion Criteria

Participants fall in this category would be excluded of the study.

1. 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;
2. have severe shoulder/arm or hip/knee contracture/ pain and;
3. Pregnant women.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Assessment Upper Extremity and Lower Extremity (FMA-UE and FMA-LE);	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);	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)	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 Outcome Measures

Name	Time	Method
Quality of life (QOL): physical and mental health using the 12-Item Short Form Health Survey (SF 12v2)	10 weeks	The 12-Item Short Form Health Survey (SF-12v2) is a validated questionnaire widely used to assess health-related quality of life (HRQOL) focusing on both physical and mental health dimensions. The SF-12v2 consists of 12 questions that cover eight domains of health, leading to two primary summary scores: Physical Component Summary (PCS) and Mental Component Summary (MCS).The SF-12v2 exhibits high internal consistency, with Cronbach's alpha coefficients typically exceeding 0.80 for both the PCS and MCS components.
User experience (UX) using questionnaires (designed based on UEQ-S)	10 weeks	User Experience (UX) encompasses all aspects of the end-user's interaction with a company, its services, and its products. To systematically evaluate UX, particularly in digital products. The UEQ-S consists of 8 items that are grouped into 6 key dimensions of user experience.The UEQ-S shows high internal consistency, with Cronbach's alpha values generally exceeding 0.70 for the various dimensions, ensuring that the items within each dimension measure a coherent aspect of user experience.
Activities of Daily Living (ADL) using the Barthel Index (BI)	10 weeks	The Barthel Index (BI) is a widely recognized tool for assessing an individual's ability to perform Activities of Daily Living (ADLs). It evaluates the extent to which individuals can maintain self-care and functional independence. The Barthel Index consists of 10 items.Each item is scored based on the level of independence demonstrated, with total scores ranging from 0 to 100. Higher scores indicate greater independence in performing daily activities. The Barthel Index exhibits high internal consistency, with Cronbach's alpha values typically above 0.80.

Trial Locations

Locations (1)

Railway General Hospital; 🇵🇰 Rawalpindi, Punjab, Pakistan