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StrokeNCT07487207

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

A study testing Augmented Reality-Functional Integrated Training (AR-FIT) Group, Augmented Reality-Generic Balance Training (GBT) Group and Conventional Balance Training (CBT) Group in people with Stroke, run by Riphah International University at 1 site in Pakistan.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 40 to 70 years
Conditions the study is for
Stroke
What is being tested?
Augmented Reality-Functional Integrated Training (AR-FIT) Group, Augmented Reality-Generic Balance Training (GBT) Group and Conventional Balance Training (CBT) Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 sitePakistan
Study dates
Mar 2026to 20 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Arshad Nawaz Malik, PhD Rehab contact

03334503754

arshad.nawaz@riphah.edu.pk

Pakistan1 site
  • Railway General Hospital, Rawalpindi

    Rawalpindi, Punjab Province, 44000

    Abrish Habib Abbasi, PhD* Rehab, 923155311799, abrish.habib@riphah.edu.pk

    Arshad Nawaz Malik, PhD Rehab, 923334503754, arshad.nawaz@riphah.edu.pk

Other trials in Pakistan

About this study

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.

Read the 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.

Conditions
Stroke
Being tested
Augmented Reality-Functional Integrated Training (AR-FIT) Group, Augmented Reality-Generic Balance Training (GBT) Group, Conventional Balance Training (CBT) Group
Keywords
Augmented Reality Rehabilitation, Balance Training, Functional Mobility, Stroke Rehabilitation, Tasks- Oriented training, Technology Assisted training
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Augmented Reality-Functional Integrated Training (AR-FIT) GroupOther

    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.

  • Augmented Reality-Generic Balance Training (GBT) GroupOther

    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.

  • Conventional Balance Training (CBT) GroupOther

    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.

Study groups in NCT07487207
Study groupRoleWhat they receive
AR Functional Integrated Training (AR-FIT) GroupExperimentalIn 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.
Receives: Other: Augmented Reality-Functional Integrated Training (AR-FIT) Group
AR Generic Balance Training (AR-GBT) GroupActive comparatorIn 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.
Receives: Other: Augmented Reality-Generic Balance Training (GBT) Group
Conventional Balance Training (CBT) GroupActive comparatorIn 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.
Receives: Other: Conventional Balance Training (CBT) Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Berg Balance Scale (BBS)

    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.

    Measured: Baseline-4 Weeks-8 Week-3 Months Follow Up

  2. Timed Up & Go (TUG)

    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.

    Measured: Baseline-4 Weeks-8 Week-3 Months Follow Up

  3. Balance Evaluation Systems Test (Mini-BESTest)

    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.

    Measured: Baseline-4 Weeks-8 Week-3 Months Follow Up

  4. FUGL Meyer (Lower limb)

    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.

    Measured: Baseline-4 Weeks-8 Week-3 Months Follow Up

Secondary outcomes (2)
  1. User Engagement Questionnaire (UEQ)

    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.

    Measured: 8 Weeks

  2. Stroke Impact Scale (SIS v3.0)

    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.

    Measured: Baseline-4 Weeks-8 Week-3 Months Follow Up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2026
  2. Study startMar 2026 (estimated)
  3. Primary completion20 Dec 2027 (estimated)
  4. Study completion20 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07487207
Sponsor's protocol ID
REC/PhD/011107
Status last verified
Mar 2026
First submitted
17 Mar 2026
Last updated
23 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Augmented Reality-Functional Integrated Training (AR-FIT) Group, Augmented Reality-Generic Balance Training (GBT) Group and Conventional Balance Training (CBT) Group in people with Stroke, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Arshad Nawaz Malik, PhD Rehab (03334503754, arshad.nawaz@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Berg Balance Scale (BBS) (time frame: Baseline-4 Weeks-8 Week-3 Months Follow Up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.

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