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Studying the effect of virtual reality and transcranial electrical stimulation in stroke patients

Comparing the effect of virtual reality with transcranial direct current during walking on the outcomes of fear of falling, balance, and function in patients with stroke

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20251005067515N1
Enrollment
32
Registered
2025-10-23
Start date
2025-11-22
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

stroke. Cerebrovascular disease, unspecified

Interventions

Intervention 1: Intervention group:transcranial direct current. In addition to conventional physiotherapy (20 minutes of electrotherapy with FES current and 20 minutes of conventional exercise therapy
one 10-minute period where the stride length on the VR monitor is adjusted by two green lines according to the patients ability at the beginning of that session. The patient must place the sole of the

Sponsors

University of social welfare and rehabilitation sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 70 Years

Inclusion criteria

Inclusion criteria: Stroke diagnosis by a specialist. Patients with ischemic stroke, with hemiplegia in the subacute and chronic phases who refer to Rafidah Rehabilitation Clinic. Age 40 to 70 years Patients must be able to understand and speak Persian. Do not receive other rehabilitation interventions such as occupational therapy at the same time as physiotherapy sessions. Patients must be able to understand and follow the therapist's instructions (having sufficient cognitive ability to understand and perform the exercises; assessed by MMSE test (MMSE =21). ability to stand and walk at least 10 meters with or without assistive devices). Spasticity severity of the ankle dorsiflexor group on the injured side is 2 or less, according to the Modified Ashworth Scale (MAS) HADS score <16 to enable cooperation and prevent cases of severe depression (mild and moderate depression will be allowed).

Exclusion criteria

Exclusion criteria: Neurological diseases (e.g. Parkinson's, MS) or significant neurological disorders that affect the patient's balance or gait will not be included in the study. Patients with significant musculoskeletal (or current fracture in the limbs) or vascular disorders will not be included in the study. Patients with acute medical conditions at the time of testing and data collection will not be included in the study. Patients with hearing impairments that would prevent them from communicating with the therapist will not be included in the study. Patients with severe cognitive impairments (such as dementia) or behavioral disorders that would prevent them from safely participating in the assessment process will not be included in the study Patients at high risk of cardiac complications during activity, taking medications that may negatively affect cognitive function, or having speech disorders such as aphasia that prevent the individual from communicating verbally will not be included in the study. Patients who are unwilling to participate in the evaluation process will not be included in the study. Patients who have visual impairment (hemianopia) or vestibular impairment will not be included in the study.

Design outcomes

Primary

MeasureTime frame
Falls Efficacy Scale-International questionnaire. Timepoint: Before the intervention begins and after the intervention ends. Method of measurement: It consists of 16 items, each rated from 1 (not at all worried) to 4 (very worried), with a minimum score of 16 and a maximum score of 64. A higher score indicates a higher fear of falling in individuals.

Secondary

MeasureTime frame
Mini-Balance Evaluation Systems Test. Timepoint: Before and after the study. Method of measurement: It consists of 14 items in the areas of anticipated movements, postural responses, sensory orientation while standing on a flat or inclined surface, and dynamic stability during walking. Each item is rated on a 2-point ordinal scale from 0 to 2. A score of 0 indicates that an individual is unable to perform the task in question, and a score of 2 indicates normal performance. The maximum score for this test is 28.;Biodex Balance System. Timepoint: Before and after the study. Method of measurement: Three 20-second trials are performed with 30-second rest intervals, with eyes open. The average of the three repetitions will be used for the final analysis. If the patient is able, levels 7, 6, and 5 will be performed in the same order.;10-Meter Walk test. Timepoint: Before and after the study. Method of measurement: A specific, smooth, obstacle-free 10-meter path measures the time taken to cover a distance of 2 to 8 meters (precisely, when the toes pass the mentioned landmarks), and thus, walking speed can be calculated.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAkram Divandari

University of social welfare and rehabilitation sciences

akramdivandari2016@gmail.com+98 21 3382 2252

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026