- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07629791
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
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Abrish H Abbasi
- Telefonní číslo: 03155311799
- E-mail: abrish.habib@riphah.edu.pk
Studijní záloha kontaktů
- Jméno: Arshad Nawaz Malk, PhD Rehab
- Telefonní číslo: 03334503754
- E-mail: arshad.nawaz@riphah.edu.pk
Studijní místa
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Punjab Province
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Rawalpindi, Punjab Province, Pákistán, 44000
- Railway General Hospital
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Kontakt:
- Abrish Habib Abbasi, PhD* Rehab
- Telefonní číslo: 03155311799
- E-mail: abrish.habib@riphah.edu.pk
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Dílčí vyšetřovatel:
- Arshad Nawaz Malik, PhD Rehab
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Vrchní vyšetřovatel:
- Aaleen Fatima Fatima, MS-NMPT*
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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.
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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.
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Aktivní komparátor: 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.
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Berg Balance Scale (BBS)
Časové okno: Baseline-4 Weeks-8 Week-1 Month Follow Up
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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:
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Baseline-4 Weeks-8 Week-1 Month Follow Up
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Timed Up and Go Test (TUG)
Časové okno: Baseline-4 Weeks-8 Week-1 Month Follow Up
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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.
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Baseline-4 Weeks-8 Week-1 Month Follow Up
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Postural Assessment Scale for Stroke (PASS)
Časové okno: Baseline-4 Weeks-8 Week-1 Month Follow Up
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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.
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Baseline-4 Weeks-8 Week-1 Month Follow Up
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Functional Reach Test
Časové okno: Baseline-4 Weeks-8 Week-1 Month Follow Up
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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)
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Baseline-4 Weeks-8 Week-1 Month Follow Up
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Fugl-Meyer Assessment (FMA) (LE)
Časové okno: Baseline-4 Weeks-8 Week-1 Month Follow Up
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Evaluates lower extremity motor recovery post-stroke, including reflexes, voluntary movement, and coordination.
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Baseline-4 Weeks-8 Week-1 Month Follow Up
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Activities-specific Balance Confidence (ABC) Scale
Časové okno: Baseline-4 Weeks-8 Week-1 Month Follow Up
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Assesses confidence in performing ambulatory activities.
16-item self-report questionnaire.
Test-retest ICC = 0.91
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Baseline-4 Weeks-8 Week-1 Month Follow Up
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Aaleen Fatima, MS-NMPT*, Riphah International Unversity
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Cerebrovaskulární poruchy
- Onemocnění mozku
- Onemocnění centrálního nervového systému
- Nemoci nervového systému
- Cévní onemocnění
- Kardiovaskulární choroby
- Mrtvice
- Terapeutika
- Disciplíny a činnosti chování
- Elektrická stimulační terapie
- Kvisulská terapie
- Psychiatrické somatické terapie
- Electroshock
- Psychologické techniky
- Kyselina salicylhydroxamová
- Transkraniální stimulace přímého proudu
Další identifikační čísla studie
- 02264/ Aaleen Fatima
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