Clinical trial NCT06720194: Upper-limb Functional Recovery With Virtual Reality System (BTs-Nirvana) Associated With Conventional Therapy in Hospitalized Subacute Stroke Patients
Official title: Upper-limb Functional Recovery With Virtual Reality System (BTs-Nirvana) Associated With Conventional Therapy in Hospitalized Subacute Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subacute Stroke
Keywords: stroke rehabilitation
upper limb recovery
physical therapy
virtual reality therapy
daily-life activities
randomized controlled trial
Lead sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Sponsor class: OTHER
Collaborators: name: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
First posted: 2024-12-06
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this pilot study is to evaluate if a semi-inmersive virtual reality device works in the recovery of the function of the upper limb affected in hospitalized patients who have suffered a stroke.

Reseachers will compare the virtual reality device plus the usual treatment to usual treatment to see if virtual reality device works to recovery upper limb function.

Participants will be able to receive conventional treatment or virtual therapy plus conventional treatment 5 days a week for 4 weeks.

When they are discharged, they will come to the hospital 2 times to be reviewed, 3 months and 1 year after receiving treatment.


Eligibility criteria: Inclusion Criteria:

* Ischemic or hemorrhagic stroke confirmed by neuroimaging.
* No previous stroke.
* Subacute phase (between 1 and 6 months after the stroke).
* Ability to sit with or without support.
* Maximum 4 on the Muscle Strength Scale (MRC) for shoulder flexion and flexion-extension of the elbow of the upper limb on the affected side.
* Ability to understand and accept study procedures and to sign an informed consent having been previously informed.

Exclusion Criteria:

* Previous history of brain injury, stroke and neurological or neuropsychiatric diseases.
* Cognitive alterations, dementia, aphasia or other alteration that causes inability to understand the meaning of the study.
* Clinical inestability
* Loss of visual capacity that difficults recognizing figures on the screen.
* Orthopedic conditions involving upper limbs.
* Refusal to participate in the study.

Primary outcomes:
measure: Upper limb motor function as assessed by Fugl-Meyer Upper-Limb scale (FM-UL)
timeFrame: at baseline, 4 weeks, 3 months and a year after treatment
Secondary outcomes:
measure: Daily-life activities as assessed as Barthel Index (BI)
timeFrame: at baseline, 4 weeks, 3 months and a year after treatment
measure: Trunk control as assessed as Control Trunk Test (TCT)
timeFrame: at baseline, 4 weeks, 3 months and a year after treatment
measure: Daily-life activities as assessed as Self-Assessment of Role Performance and Activities of Daily Living (SARA-TM)
timeFrame: at baseline, 4 weeks, 3 months and a year after treatment
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Hospital Universitario Regional de Malaga
Study officials:
References: