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

NCT07487207 | Not Yet Recruiting

• 1 other identifier: REC/PhD/011107
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke

Keywords

Augmented Reality Rehabilitation; Balance Training; Functional Mobility; Stroke Rehabilitation; Tasks- Oriented training; Technology Assisted training

Outcome Measures

Primary Outcomes (4)

• 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.

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

• 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.

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

• 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.

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

• 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.

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

Secondary Outcomes (2)

• User Engagement Questionnaire (UEQ)

  8 Weeks

• Stroke Impact Scale (SIS v3.0)

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

Study Arms (3)

AR Functional Integrated Training (AR-FIT) Group

EXPERIMENTAL

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

AR Generic Balance Training (AR-GBT) Group

ACTIVE COMPARATOR

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

Conventional Balance Training (CBT) Group

ACTIVE COMPARATOR

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

Interventions

Augmented Reality-Functional Integrated Training (AR-FIT) Group OTHER

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.

AR Functional Integrated Training (AR-FIT) Group

Augmented Reality-Generic Balance Training (GBT) Group OTHER

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.

AR Generic Balance Training (AR-GBT) Group

Conventional Balance Training (CBT) Group OTHER

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.

Conventional Balance Training (CBT) Group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Railway General Hospital, Rawalpindi

Rawalpindi, Punjab Province, 44000, Pakistan

Location

MeSH Terms

Conditions

Stroke

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Abrish Habib Abbasi, Phd* Rehab

  Riphah International Unversity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arshad Nawaz Malik, PhD Rehab

CONTACT

03334503754; arshad.nawaz@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 23, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 20, 2027
• Study Completion (Estimated): December 20, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)