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Completed

NCT Number: NCT06761781

Augmented Reality for Stroke Rehabilitation

The study aims to determine the effectiveness of Augmented reality on motor function, balance, and functional ambulation in stroke patients.

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Key information

Conditions

Stroke/Brain Attack Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Railway General Hospital

Rawalpindi, Punjab Province, 46060, Pakistan

About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Augmented Reality

Other

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.

Traditional Training

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 7, 2025
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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