Effects of Ecologically Valid VR Task-Oriented Exercises on Post-Stroke Motor and Cognitive Function

NCT07682194 | Completed

• 6 other identifiers: P0524032022PID2022-141498OA-I00RTC2019-006933-7INREIA/2024/73CIDEXG/2022/1560/2023
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Why is this study being done? After a stroke, many people have problems with movement, such as walking, balance, and using their arms and hands. They may also experience difficulties with thinking skills, including attention, memory, and problem-solving. These movement and thinking abilities work closely together during everyday activities, such as preparing a meal, shopping, or moving safely through the home. Traditional rehabilitation often treats movement and thinking problems separately. However, difficulties with attention, planning, and decision-making can affect a person's ability to move safely and learn new motor skills. Because of this, rehabilitation approaches that train both movement and thinking skills at the same time may provide greater benefits. Virtual reality (VR) technology can create realistic, interactive environments that allow people to practice everyday activities in a safe setting. However, there is limited research on VR programs that simultaneously challenge both movement and thinking skills, and little is known about whether any benefits last over time. What is the purpose of this study? The purpose of this study is to compare a virtual reality-based rehabilitation program that combines movement and cognitive training in realistic everyday environments with conventional occupational therapy. The study will evaluate whether the VR program leads to greater improvements in motor function and cognitive function after stroke and whether these improvements are maintained over the long term.

Conditions

Stroke

Keywords

virtual reality; ecollogical validity; dual-task; balance; cognition; stroke; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in Berg Balance Scale

  Change in the balance of the Berg Balance Scale from baseline to the end of the intervention and from the end of the intervention to follow-up. The Berg Balance Scale is a clinical tool that assesses a person's static and dynamic balance to determine their risk of falling. It is primarily used for older adults and patients with neurological or motor disorders. Score range 0-54

  From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention

Secondary Outcomes (7)

• Change in Functional Reaches Test

  From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention

• Change in Four Square Step Test

  From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention

• Change in the 10-meters walk Test

  From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention

• Change in the Activities-Specific Balance Confidence Scale

  From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention

• Change in the Conner's Continuous Performance Test III

  From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention

Study Arms (2)

Control

ACTIVE COMPARATOR

Conventional occupational therapy

Other: Conventional occupational therapy

Experimental

EXPERIMENTAL

Combined virtual reality-based exercises and conventional occupational therapy

Other: Conventional occupational therapy; Other: Virtual reality-based exercises in ecologically valid environments

Interventions

Conventional occupational therapy OTHER

Each session consists of three components. The first component includes preparatory activities designed to improve function of the affected upper limb. The second component focuses on fine motor skill training through exercises targeting reaching, grasping, object manipulation, and movements across the body's midline. The third component addresses individual motor and cognitive impairments through the practice of Basic Activities of Daily Living and Instrumental Activities of Daily Living, as well as structured problem-solving tasks related to everyday situations.

Control; Experimental

Virtual reality-based exercises in ecologically valid environments OTHER

The intervention consists of interactive video games to train activities of daily living in a customizable digital version of the participant's own kitchen. During training, participants control a sex-matched avatar that reflects their real-time movements. They interact with common kitchen objects while practicing tasks that target both motor abilities, such as balance, posture, and hand-eye coordination, and cognitive abilities, such as attention, memory, planning, and problem-solving. The system can use photographs of the participant's home kitchen to create a familiar and realistic virtual environment. This approach is intended to support the transfer of skills practiced during therapy to the participant's everyday activities at home.

Experimental

Eligibility Criteria

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

You may qualify if:

• Diagnosis of stroke confirmed by computed tomography or magnetic resonance imaging
• Chronicity \> six months
• Ausence of severe cognitive deficits (Mini-Mental State Examination \> 23)
• Ability to stand safely and without assistance
• No or minimal muscle tone (Modified Ashworth Scale \< 3).

You may not qualify if:

• Severe visual or hearing deficits
• Unilateral spatial neglect
• Ataxia
• Orthopedic abnormalities
• Lower limb pain syndrome or peripheral nerve injury affecting the lower limbs.

Sponsors & Collaborators

• Hospitales Nisa: lead
• Universitat Politècnica de València: collaborator

Study Sites (1)

IRENEA. Instituto de Rehabilitación Neurológica

Valencia, Spain

Location

Related Links

• Related Info

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Roberto Llorens, PhD

  Universitat Politecnica de Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: July 2, 2026
• Study Start: February 16, 2023
• Primary Completion: October 9, 2025
• Study Completion: October 9, 2025
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)