Augmented Reality for Stroke Rehabilitation

April 22, 2025 updated by: Riphah International University
The study aims to determine the effectiveness of Augmented reality on motor function, balance, and functional ambulation in stroke patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Rawalpindi, Punjab, Pakistan, 46060
        • Railway General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Augmented Reality Training
Augmented reality training to Experimental group
Other: Augmented Reality

Each participant will receive a standard trial consisting of 20 training sessions (2-5 sessions per week, 120 min per session) in consecutive 4-10 weeks. Each session will consist of 2-10 exercises selected by the trainer from a pool of 46 exercises. The selected exercises will be tailored based on the participant's condition and progress. The exercise pool will be designed as comprehensively as possible to cover the upper limb (22 exercises and lower limb (7 exercises) motor functions, balance ability (11 exercises), or/and coordination (6 exercises).

Each exercise with a duration ranging from 3 to 23 min, and will be determined by a set of parameters that can be adjusted to the individuals dynamically according to the participant's performance.
Active Comparator: Traditional Treatment
Task based training to the Control Group
Other: Traditional Training
Each participant will receive a Traditional training based on Task oriented training consisting of 20 training sessions (2-5 sessions per week, 120 min per session) in consecutive 4-10 weeks. Exercises will be tailored based on the participant's condition and progress. The exercises will cover the upper limb, lower limb, motor functions, balance ability and coordination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 weeks
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.
10 weeks
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).
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life (QOL): physical and mental health using the 12-Item Short Form Health Survey (SF 12v2)
Time Frame: 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.
10 weeks
User experience (UX) using questionnaires (designed based on UEQ-S)
Time Frame: 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.
10 weeks
Activities of Daily Living (ADL) using the Barthel Index (BI)
Time Frame: 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.
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Mirza Obaid Baig, MS-NMPT, Riphah International University
  • Principal Investigator: Arshad Nawaz Malik, PhD Rehab, Riphah International University
  • Principal Investigator: Abrish Habib Abbasi, PhD* Rehab, Riphah International University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 31, 2024

Primary Completion (Actual)

March 30, 2025

Study Completion (Actual)

March 30, 2025

Study Registration Dates

First Submitted

January 1, 2025

First Submitted That Met QC Criteria

January 6, 2025

First Posted (Actual)

January 7, 2025

Study Record Updates

Last Update Posted (Actual)

April 25, 2025

Last Update Submitted That Met QC Criteria

April 22, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/01997 Abrish Habib

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe