Upper-limb Functional Recovery With Virtual Reality System (BTs-Nirvana) Associated With Conventional Therapy in Hospitalized Subacute Stroke Patients

Not Applicable

Completed

• Conditions: Subacute Stroke

• Registration Number: NCT06720194
• Lead Sponsor: Lorena Aguilar Cano

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-17
• Primary Completion: 2023-04-03
• Study Completion: 2023-04-03
• Study First Submitted: 2024-11-27
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-02
• Last Update Submitted: 2024-12-02
• Study First Posted: 2024-12-06
• Last Update Posted: 2024-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Upper limb motor function as assessed by Fugl-Meyer Upper-Limb scale (FM-UL)	at baseline, 4 weeks, 3 months and a year after treatment	The maximum value of the motor function in the FM-UL scale is 66 points. A higher score corresponds to a better state of operation of the patient.

Secondary Outcome Measures

Name	Time	Method
Daily-life activities as assessed as Barthel Index (BI)	at baseline, 4 weeks, 3 months and a year after treatment	BI evaluates 10 daily-life activities: eating, wash, dress, groom, defecate, urinate, go to the toilet, move, chair-bed, ambulation, going up and down stairs. The total score ranges from 0 to 100. The global results are grouped into four categories of dependency: total, severe, moderate or mild. Lower score means subject has more dependence ant higher score means more independence.
Trunk control as assessed as Control Trunk Test (TCT)	at baseline, 4 weeks, 3 months and a year after treatment	TCT is a simple test that explores four movements. Each of the sections are scored as follows: 0 points if the patient is unable to perform the movement without assistance, 12 points if able to perform the movement abnormally and 25 points if the patient is able to complete the movement normally. The total score is the sum of the results of the four tests and its value can range from 0 to 100.
Daily-life activities as assessed as Self-Assessment of Role Performance and Activities of Daily Living (SARA-TM)	at baseline, 4 weeks, 3 months and a year after treatment	SARA-TM is a questionnaire that users fill out with the orientation of the therapists. It is based on their perceptions of various daily-life activities. We have asked about items related to self-care, food, maintenance of postures, movement, manipulation and pain. Each one of the domains consists of different items that correspond to different activities. Each item is scored from 0 to 4 depending on the degree of difficulty in performing the activities. Lower values represent better function

Trial Locations

Locations (1)

Hospital Universitario Regional de Malaga; 🇪🇸 Málaga, Spain