Effects of Augmented Reality (AR) and Transcranial Direct Current Stimulation (tDCS)

NCT07629791 | Not Yet Recruiting

• 1 other identifier: 02264/ Aaleen Fatima
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this randomized controlled trial is to determine the effects of Augmented Reality (AR)-based balance training on improving balance and postural control in chronic stroke survivors and whether the addition of transcranial Direct Current Stimulation (tDCS) to AR training produces superior outcomes compared to AR training alone.

Conditions

Stroke

Keywords

Stroke rehabilitation; Balance training; Postural control; Augmented reality; Transcranial Direct Current Stimulation

Outcome Measures

Primary Outcomes (6)

• Berg Balance Scale (BBS)

  Berg Balance Scale is a performance-based measure used to assess static and dynamic balance abilities in stroke survivors. It consists of 14 functional tasks such as standing, reaching, turning, and transfers, performed under supervision. Scoring: Each item is rated on a 5-point ordinal scale (0-4), where 0 = unable to perform and 4 = performs independently. The maximum score is 56 points. Interpretation: * 0-20 = High risk of falls * 21-40 = Moderate risk of falls * 41-56 = Low risk of falls

  Baseline-4 Weeks-8 Week-1 Month Follow Up

• Timed Up and Go Test (TUG)

  The TUG test measures basic functional mobility and is a quick, simple tool to evaluate fall risk and dynamic balance. Participants are asked to stand up from a chair, walk 3 meters, turn around, walk back, and sit down. Scoring: The time (in seconds) taken to complete the task is recorded. * \<10 seconds = Completely mobile * \<20 seconds = Mostly independent * 20-29 seconds = Variable mobility * ≥30 seconds = Impaired walking, high fall risk

  Baseline-4 Weeks-8 Week-1 Month Follow Up

• Postural Assessment Scale for Stroke (PASS)

  The PASS is a clinical tool specifically designed to assess postural control in stroke patients. It consists of 12 items divided into two sections: Maintaining Posture (sitting, standing, lying) and Changing Posture (transfers, standing up, picking objects). Scoring: Each item is scored on a scale of 0-3, with a total maximum score of 36 points. * Higher scores = Better postural control * Lower scores = Higher risk of falls and dependence in mobility

  Baseline-4 Weeks-8 Week-1 Month Follow Up

• Functional Reach Test

  Predicts fall risk by measuring dynamic trunk reach. Normal value = 22.7 cm. ICC = 0.80-0.88 Inter-Class = 0.94-0.97 Test-retest = 0.84-0.86 (p\<0.001)

  Baseline-4 Weeks-8 Week-1 Month Follow Up

• Fugl-Meyer Assessment (FMA) (LE)

  Evaluates lower extremity motor recovery post-stroke, including reflexes, voluntary movement, and coordination.

  Baseline-4 Weeks-8 Week-1 Month Follow Up

• Activities-specific Balance Confidence (ABC) Scale

  Assesses confidence in performing ambulatory activities. 16-item self-report questionnaire. Test-retest ICC = 0.91

  Baseline-4 Weeks-8 Week-1 Month Follow Up

Study Arms (2)

Augmented reality Combined with TDCs + Convention therapy

EXPERIMENTAL

Participants will receive 12 sessions over 4 weeks (3 sessions per week), each lasting 60 minutes. Transcranial Direct Current Stimulation (tDCS) will be applied for 15 minutes immediately before the AR balance training session. Each session will consist of 30 minutes of interactive AR-based balance games with real-time visual and auditory feedback, followed by 15 minutes of conventional therapy targeting balance and mobility. All sessions will be supervised by a physiotherapist, and participants' queries during the training will be addressed.

Other: Augmented reality combined with tDCS & Convention therapy

Augmented reality with Sham+ Convention therapy

ACTIVE COMPARATOR

The Control group will undergo 12 sessions over 4 weeks (3 sessions per week), with each session lasting 60 minutes, consisting of 30 minutes of interactive balance tasks through AR-based games with real-time visual and auditory feedback, 15 minutes of conventional physiotherapy-based balance and mobility training, and 15 minutes of sham stimulation using the tDCS setup without active current flow.

Other: Augmented reality combined with Sham & Convention therapy

Interventions

Augmented reality combined with tDCS & Convention therapy OTHER

Participants will receive 12 sessions over 4 weeks (3 sessions per week), each lasting 60 minutes. Transcranial Direct Current Stimulation (tDCS) will be applied for 15 minutes immediately before the AR balance training session. Each session will consist of 30 minutes of interactive AR-based balance games with real-time visual and auditory feedback, followed by 15 minutes of conventional therapy targeting balance and mobility. All sessions will be supervised by a physiotherapist, and participants' queries during the training will be addressed.

Augmented reality Combined with TDCs + Convention therapy

Augmented reality combined with Sham & Convention therapy OTHER

The participants in this group will undergo 12 sessions over 4 weeks (3 sessions per week), with each session lasting 60 minutes, consisting of 30 minutes of interactive balance tasks through AR-based games with real-time visual and auditory feedback, 15 minutes of conventional physiotherapy-based balance and mobility training, and 15 minutes of sham stimulation using the tDCS setup without active current flow.

Augmented reality with Sham+ Convention therapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Balance impairment confirmed by Berg Balance Scale (BBS) score 21-44.
• Age between 18-90 years.
• Mild or no spasticity in lower limb (MAS ≤ 2)
• have sufficient cognition to follow the instructions provided by the therapists and the computer.

You may not qualify if:

• Individuals with implanted electronic devices (e.g., pacemakers), due to interaction risk with tDCS
• Other medical or psychological conditions affecting participation (e.g., severe pain, epilepsy, pacemaker).
• Patients with severe cognitive deficits or visual impairments

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Railway General Hospital

Rawalpindi, Punjab Province, 44000, Pakistan

Location

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Aaleen Fatima, MS-NMPT*

  Riphah International Unversity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abrish H Abbasi

CONTACT

03155311799; abrish.habib@riphah.edu.pk

Arshad Nawaz Malk, PhD Rehab

CONTACT

03334503754; arshad.nawaz@riphah.edu.pk

Study Design

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

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 5, 2026
• Study Start: May 20, 2026
• Primary Completion (Estimated): October 20, 2026
• Study Completion (Estimated): November 20, 2026
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)