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

Effects of Augmented Reality (AR) and Transcranial Direct Current Stimulation (tDCS) on Balance and Postural Control in Chronic Stroke Survivors

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: Augmented reality combined with tDCS & Convention therapy; Other: Augmented reality combined with Sham & Convention therapy

Detailed Description

Stroke remains one of the leading causes of death and long-term disability worldwide, with survivors often experiencing persistent motor and sensory impairments that significantly impact their quality of life. In 2020, it caused about 6.6 million deaths and ranked third for disability-adjusted life-years (DALYs) lost, with the burden rising fastest in low- and middle-income countries. Even after surviving a stroke, many people up to 83% continue to have problems with balance and controlling their posture. These difficulties make daily activities harder, increase the chance of falling, and lower their quality of life.

Balance and postural control are important because they help us stay steady and move safely. After a stroke, these abilities often get damaged because the brain areas that control movement and coordination are affected. People who have had a stroke may walk slower, sway more when standing, and have trouble with tasks like standing up or turning around. Balance impairments manifest as altered body weight distribution patterns, reduced weight-bearing capacity through the affected limb, and diminished postural stability, leading to increased fall risk and decreased participation in activities of daily living. In fact, only a small number of stroke survivors can walk freely without help, and many experiences falls more often than people without stroke. Stroke survivors fall more than twice as often as healthy controls, with balance impairments leading to decreased participation in activities of daily living, fear of falling, and social isolation. Augmented Reality (AR) technology has emerged as a promising intervention for stroke rehabilitation. AR systems provide immersive and interactive virtual environments that can enhance motor rehabilitation through collaborative stimulation of multiple sensory channels, including visual, auditory, and proprioceptive feedback. This multimodal approach facilitates repetitive practice with real-time feedback and encouragement, potentially enhancing rehabilitation effectiveness through increased engagement and motivation. Recent systematic reviews and meta-analyses have demonstrated that AR-based interventions can significantly improve both upper and lower limb function in stroke patients.

Studies have shown that AR training leads to improvements in obstacle avoidance, balance performance, and functional mobility compared to conventional rehabilitation alone. The technology's ability to provide personalized, adaptive training environments allows for customization based on individual patient needs and capabilities, potentially optimizing therapeutic outcomes. The integration of AR with traditional rehabilitation methods has shown particular promise, with combined approaches yielding better functional outcomes than either intervention alone.

Transcranial direct current stimulation (tDCS) represents a non-invasive neuromodulation technique that has gained considerable attention in stroke rehabilitation for its ability to modify cortical excitability and potentially enhance neuroplasticity. By delivering low-intensity electrical current through scalp electrodes, tDCS can modulate neuronal activity in targeted brain regions, with anodal stimulation typically increasing cortical excitability and cathodal stimulation having inhibitory effects. Research has demonstrated that tDCS can improve various aspects of motor function in stroke patients, including balance and postural control. Studies have shown immediate and sustained effects of tDCS on balance parameters, with improvements in weight-bearing distribution, postural stability, and functional mobility measures.

Cerebellar tDCS, in particular, has shown superior effects compared to cerebral stimulation for improving balance and gait function in chronic stroke patients. The mechanisms underlying tDCS effects involve modulation of cortical and spinal neuronal circuits involved in movement control. Meta-analyses have indicated that tDCS can provide significant benefits for balance outcomes in stroke patients, although the quality of evidence remains variable and further research is needed to optimize stimulation parameters and patient selection criteria.

The concept for combining Augmented Reality (AR) and transcranial Direct Current Stimulation (tDCS) in stroke rehabilitation is grounded in the principles of neuroplasticity, which refers to the brain's capacity to reorganize and form new neural connections following injury. AR provides enriched, task-specific sensory environments that facilitate intensive motor practice, while tDCS modulates cortical excitability to enhance synaptic plasticity. Together, these interventions may produce synergistic effects by optimizing neural reorganization and functional recovery. Although both modalities have demonstrated individual efficacy in improving balance and postural control post-stroke, their combined therapeutic potential remains underexplored, highlighting the need for further research to advance multimodal rehabilitation strategies.

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abrish H Abbasi; Phone Number: 03155311799; Email: abrish.habib@riphah.edu.pk
• Study Contact Backup: Name: Arshad Nawaz Malk, PhD Rehab; Phone Number: 03334503754; Email: arshad.nawaz@riphah.edu.pk

Study Locations

• Pakistan
  • Punjab Province
    • Rawalpindi, Punjab Province, Pakistan, 44000
      • Railway General Hospital
      • Contact: Abrish Habib Abbasi, PhD* Rehab; Phone Number: 03155311799; Email: abrish.habib@riphah.edu.pk
      • Sub-Investigator: Arshad Nawaz Malik, PhD Rehab
      • Principal Investigator: Aaleen Fatima Fatima, MS-NMPT*

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Augmented reality Combined with TDCs + Convention therapy; 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; 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.
Active Comparator: Augmented reality with Sham+ Convention therapy; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Aaleen Fatima, MS-NMPT*, Riphah International Unversity

Study record dates

Study Major Dates

• Study Start (Estimated): May 20, 2026
• Primary Completion (Estimated): October 20, 2026
• Study Completion (Estimated): November 20, 2026

Study Registration Dates

• First Submitted: June 1, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 5, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Transcranial Direct Current Stimulation; Balance training; Augmented reality; Stroke rehabilitation; Postural control
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Therapeutics; Behavioral Disciplines and Activities; Electric Stimulation Therapy; Convulsive Therapy; Psychiatric Somatic Therapies; Electroshock; Psychological Techniques; salicylhydroxamic acid; Transcranial Direct Current Stimulation
• Other Study ID Numbers: 02264/ Aaleen Fatima

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