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StrokeNCT07629791

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

A study testing Augmented reality combined with tDCS & Convention therapy in people with Stroke, run by Riphah International University at 1 site in Pakistan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Stroke
What is being tested?
Augmented reality combined with tDCS & Convention therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
28 participants
Where
1 sitePakistan
Study dates
20 May 2026to 20 Nov 2026
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 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

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 Malk, PhD Rehab contact

03334503754

arshad.nawaz@riphah.edu.pk

Pakistan1 site, 1 recruiting
  • Railway General Hospital

    Rawalpindi, Punjab Province, 44000

    Abrish Habib Abbasi, PhD* Rehab, 03155311799, abrish.habib@riphah.edu.pk

    Arshad Nawaz Malik, PhD Rehab

    Recruiting

Other trials in Pakistan

About this study

Official title: 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.

Read the 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.

Conditions
Stroke
Being tested
Augmented reality combined with tDCS & Convention therapy, Augmented reality combined with Sham & Convention therapy
Keywords
Stroke rehabilitation, Balance training, Postural control, Augmented reality, Transcranial Direct Current Stimulation
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 combined with tDCS & Convention therapyOther

    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 Sham & Convention therapyOther

    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.

Study groups in NCT07629791
Study groupRoleWhat they receive
Augmented reality Combined with TDCs + Convention therapyExperimentalParticipants 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.
Receives: Other: Augmented reality combined with tDCS & Convention therapy
Augmented reality with Sham+ Convention therapyActive comparatorThe 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.
Receives: Other: Augmented reality combined with Sham & Convention therapy

What is being measured

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

  1. 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

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

  2. Timed Up and Go Test (TUG)

    The Timed Up and Go 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

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

  3. Postural Assessment Scale for Stroke (PASS)

    The Postural Assessment Scale for Stroke (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

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

  4. 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)

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

  5. Fugl-Meyer Assessment (FMA) (LE)

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

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

  6. Activities-specific Balance Confidence (ABC) Scale

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

    Measured: Baseline-4 Weeks-8 Week-1 Month 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 posted5 Jun 2026
  2. Study start20 May 2026
  3. Primary completion20 Oct 2026 (estimated)
  4. Study completion20 Nov 2026 (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
Participant
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07629791
Sponsor's protocol ID
02264/ Aaleen Fatima
Status last verified
Jul 2026
First submitted
1 Jun 2026
Last updated
20 Jul 2026
Results posted
No
Data monitoring committee
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 combined with tDCS & Convention therapy 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 20 Jul 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 Abrish H Abbasi (03155311799, abrish.habib@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-1 Month Follow Up). The study lists 6 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 20 Jul 2026.

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Clinical Trial NCT07629791 | AzTrials