Effects of Augmented Reality Functional Integrated Training (AR-FIT) on Balance and Mobility in Stroke

March 17, 2026 updated by: Riphah International University
The present study aims to develop and validate an evidence-based functional balance task library for Augmented Reality-Functional Integrated Training (AR-FIT), incorporating standardized real-object integration through expert consensus and pilot usability testing. Furthermore, the study seeks to determine the effects of AR-FIT on balance and functional mobility in stroke survivors in comparison to conventional Augmented Reality & task oriented training over an eight-week intervention period. In addition, it intends to evaluate participant motivation, engagement, and perceived task realism during AR-FIT using structured questionnaires and post-intervention interviews, thereby examining both clinical effectiveness and user-centered experience outcomes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Stroke remains a leading cause of long-term disability, with its burden rising sharply in low- and middle-income countries such as Pakistan. Despite advances in acute care, many survivors continue to experience persistent balance and mobility impairments that limit independence. While augmented reality (AR) based rehabilitation has shown promise in improving motor recovery and engagement, current AR systems often emphasize generalized or gamified tasks, offering limited opportunities for practicing functionally relevant, real-world movements. Therefore, the current study introduces an Augmented Reality-Functional Interactive Training (AR-FIT), designed to evaluate the feasibility and effectiveness of combining AR-guided feedback with real-object manipulation for post-stroke balance training. The objectives are threefold: first, to determine the feasibility and usability of AR-FIT as a balance training platform; second, to assess its impact on postural control, balance, and functional mobility compared to conventional AR training; and third, to explore patient motivation and engagement associated with tangible, ecologically valid tasks. By enhancing realism, sensory engagement, and functional relevance, this approach is expected to bridge the existing gap between digital rehabilitation technologies and the real-world demands of stroke recovery.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
78

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Pakistan
    • Punjab Province
      • Rawalpindi, Punjab Province, Pakistan, 44000
        • Railway General Hospital, Rawalpindi
        • Contact:
        • Contact:
        • Principal Investigator:
          • Abrish Habib Abbasi, PhD* Rehab

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 40-70 years with first-ever ischemic or hemorrhagic stroke (>3 months post-onset).
  • Cognitive ability: MMSE > 24.
  • No or mild spasticity in upper/lower limb MAS ≤ 2
  • Functional Ambulation Category (FAC) ≥ 3.
  • Berg Balance Scale (BBS) 20-40 (to avoid floor/ceiling effects).
  • Ability to walk 10 meters independently
  • Willingness to provide informed consent and participate regularly.

Exclusion Criteria:

  • Severe musculoskeletal or neurological comorbidities (e.g., contractures, Parkinson's disease).
  • Severe visual, neglect, or communication impairments.
  • Uncontrolled systemic illness or unstable cardiovascular condition.
  • Participation in another interventional trial within the last 3 months.

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: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AR Functional Integrated Training (AR-FIT) Group
In Augmented Reality-Functional Integrated Training (AR-FIT) Group, participants will perform structured functional balance tasks integrating augmented reality with standardized real objects (e.g., chair, step, cup, basket, Swiss ball). Exercises will target lower limb motor control, dynamic balance, trunk stability, and task-oriented mobility. The task library will consist of progressively graded functional balance tasks.
Other: Augmented Reality-Functional Integrated Training (AR-FIT) Group

Each participant will receive a standardized intervention program consisting of 24 supervised training sessions delivered over 8 consecutive weeks (3 sessions per week, approximately 45 minutes per session). All sessions will follow a structured format including a 5-7 minute warm-up phase, a 30-35 minute task-specific training phase, and a 5-6 minute cool-down period.

In Augmented Reality-Functional Integrated Training (AR-FIT) Group, participants will perform structured functional balance tasks integrating augmented reality with standardized real objects (e.g., chair, step, cup, basket, Swiss ball). Exercises will target lower limb motor control, dynamic balance, trunk stability, and task-oriented mobility. The task library will consist of progressively graded functional balance tasks.
Active Comparator: AR Generic Balance Training (AR-GBT) Group
In the AR- based Generic AR Balance Training Group, participants will undergo augmented reality-based balance training without real-object integration. The intervention will include AR-guided weight shifting, virtual stepping, diagonal reaching, trunk control tasks, and tool-based stability exercises (e.g., virtual ball reaching, wobble-board simulations). Exercises will be selected from a structured pool of balance and mobility activities and will be progressed through virtual task difficulty, speed modulation, range of motion, and repetition parameters tailored to the participant's functional level.
Other: Augmented Reality-Generic Balance Training (GBT) Group
In the AR- based Generic AR Balance Training Group, participants will undergo augmented reality-based balance training without real-object integration. The intervention will include AR-guided weight shifting, virtual stepping, diagonal reaching, trunk control tasks, and tool-based stability exercises (e.g., virtual ball reaching, wobble-board simulations). Exercises will be selected from a structured pool of balance and mobility activities and will be progressed through virtual task difficulty, speed modulation, range of motion, and repetition parameters tailored to the participant's functional level.
Active Comparator: Conventional Balance Training (CBT) Group
In the Conventional Training Group, participants will receive therapist-guided task-oriented balance training based on standard neurorehabilitation principles. Exercises will include sit-to-stand practice, stepping and step-up training, weight shifting, lunges, trunk rotation, reaching activities, and functional mobility drills using real objects without augmented reality support. Task selection and progression will be individualized according to the participant's baseline motor function and clinical progress, with adjustments made in task complexity, repetitions, external support, and environmental challenge.
Other: Conventional Balance Training (CBT) Group
In the Conventional Training Group, participants will receive therapist-guided task-oriented balance training based on standard neurorehabilitation principles. Exercises will include sit-to-stand practice, stepping and step-up training, weight shifting, lunges, trunk rotation, reaching activities, and functional mobility drills using real objects without augmented reality support. Task selection and progression will be individualized according to the participant's baseline motor function and clinical progress, with adjustments made in task complexity, repetitions, external support, and environmental challenge.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Berg Balance Scale (BBS)
Time Frame: Baseline-4 Weeks-8 Week-3 Months Follow Up
The Berg Balance Scale (BBS) is a widely used performance-based clinical measure for assessing functional balance in individuals with neurological conditions, including stroke. It consists of 14 tasks that evaluate static and dynamic balance abilities during common functional activities such as sitting, standing, reaching, turning, and transfers. Each item is scored on a 5-point ordinal scale ranging from 0 (unable to perform) to 4 (independent performance), with a maximum total score of 56 indicating better balance performance. The BBS demonstrates strong validity and high inter-rater and test-retest reliability and is commonly used to assess balance impairment and monitor rehabilitation outcomes in stroke populations.
Baseline-4 Weeks-8 Week-3 Months Follow Up
Timed Up & Go (TUG)
Time Frame: Baseline-4 Weeks-8 Week-3 Months Follow Up
The Timed Up and Go Test (TUG) is a simple and widely used clinical test for assessing functional mobility and dynamic balance. The test measures the time (in seconds) required for an individual to stand up from a chair, walk 3 meters, turn around, walk back to the chair, and sit down. Shorter completion times indicate better functional mobility. Typical interpretation suggests that <10 seconds represents normal mobility, 10-20 seconds indicates variable mobility, and ≥14 seconds is commonly considered a threshold for increased fall risk in individuals with stroke. The TUG has demonstrated strong test-retest and inter-rater reliability in stroke populations and is frequently used in rehabilitation research to evaluate mobility and fall risk. Instrumented versions of the TUG (iTUG) have also shown improved predictive capabilities and good psychometric properties.
Baseline-4 Weeks-8 Week-3 Months Follow Up
Balance Evaluation Systems Test (Mini-BESTest)
Time Frame: Baseline-4 Weeks-8 Week-3 Months Follow Up
The Mini-BESTest (Mini Balance Evaluation Systems Test) is a performance-based clinical assessment used to evaluate dynamic balance and postural control. It assesses four key balance control systems: anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. The test consists of 14 items scored on a 3-point ordinal scale (0-2), with a maximum score of 28 indicating better balance performance. The Mini-BESTest has demonstrated good construct validity and excellent inter-rater and test-retest reliability in individuals with neurological conditions, including stroke, and is widely used to assess balance impairments and monitor rehabilitation outcomes.
Baseline-4 Weeks-8 Week-3 Months Follow Up
FUGL Meyer (Lower limb)
Time Frame: Baseline-4 Weeks-8 Week-3 Months Follow Up
The Lower Extremity component of the Fugl-Meyer Assessment Lower Extremity (FMA-LE) is a stroke-specific, performance-based clinical assessment used to evaluate motor recovery of the lower limb following stroke. It measures key domains including voluntary movement within and out of synergy patterns, coordination, and reflex activity. The scale consists of multiple items scored on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully), with a maximum score of 34 indicating better lower extremity motor function. The instrument demonstrates strong construct validity and excellent reliability (r ≈ 0.99) for assessing post-stroke motor impairment and is widely used in clinical and research settings to monitor motor recovery and treatment outcomes.
Baseline-4 Weeks-8 Week-3 Months Follow Up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
User Engagement Questionnaire (UEQ)
Time Frame: 8 Weeks
The User Engagement Questionnaire (UEQ) is a standardized self-report instrument used to assess user engagement and overall user experience with interactive systems and digital applications. The questionnaire evaluates multiple dimensions of engagement, including usability, attractiveness, efficiency, stimulation, and novelty of the system. Items are rated on a Likert-type scale, and scores are analyzed to determine users' perceived satisfaction, motivation, and interaction quality with the technology. The UEQ has been widely used in digital health and rehabilitation technology research to evaluate user acceptance, engagement, and usability of technology-based interventions.
8 Weeks
Stroke Impact Scale (SIS v3.0)
Time Frame: Baseline-4 Weeks-8 Week-3 Months Follow Up
The Stroke Impact Scale is a stroke-specific, patient-reported outcome measure used to assess the multidimensional impact of stroke on health-related quality of life. The instrument evaluates eight domains including strength, hand function, mobility, activities of daily living (ADL/IADL), memory and thinking, communication, emotion, and participation. Items are rated on a 5-point Likert scale, with scores transformed to a 0-100 scale, where higher scores indicate better perceived function and quality of life. The SIS v3.0 has demonstrated strong validity, responsiveness, and high reliability in individuals with stroke and is widely used in clinical research to evaluate patient-centered outcomes following rehabilitation interventions.
Baseline-4 Weeks-8 Week-3 Months Follow Up

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Abrish Habib Abbasi, Phd* Rehab, Riphah International Unversity

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 17, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/PhD/011107

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.

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