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

NCT06720194 | Completed

• 1 other identifier: RVACV2020
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Subacute Stroke

Keywords

stroke rehabilitation; upper limb recovery; physical therapy; virtual reality therapy; daily-life activities; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Upper limb motor function as assessed by Fugl-Meyer Upper-Limb scale (FM-UL)

  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.

  at baseline, 4 weeks, 3 months and a year after treatment

Secondary Outcomes (3)

• Daily-life activities as assessed as Barthel Index (BI)

  at baseline, 4 weeks, 3 months and a year after treatment

• Trunk control as assessed as Control Trunk Test (TCT)

  at baseline, 4 weeks, 3 months and a year after treatment

• 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

Study Arms (2)

Experimental group

EXPERIMENTAL

This arm receives the virtual therapy plus the usual treatment

Device: Virtual therapy

Control Group

OTHER

This arm receives the usual treatment at the same dose and time than experimental group

Other: Usual treatment

Interventions

Virtual therapy DEVICE

Virtual therapy has been applied for four weeks, three times a week. We administered a total of twelve sessions with a duration of 30 minutes each. Prior to virtual therapy experimental group have received kinesitherapy for 15 minutes to improve and prevent muscle spasticity and joint contractures. Therapists recorded the order of the session and they have providen the same external aid to all patients. Two days a week the experimental group have received the conventional treatment for 45 minutes (kinesitherapy, strengthening exercises muscle, trunk control, transfers, standing and walking). In addition to physiotherapy treatment, participants have done occupational therapy 5 days a week (training to perform ADLs, tracking techniques and search, manipulation, reach and grasping of different utensils, etc.), for 30 minutes each session.

Experimental group

Usual treatment OTHER

Patients assigned to the control group have received the conventional treatment five days a week. They have done physiotherapy session and occupational therapy for 45 and 30 minutes a day each one.

Control Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lorena Aguilar Cano: lead
• Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud: collaborator

Study Sites (1)

Hospital Universitario Regional de Malaga

Málaga, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 6, 2024
• Study Start: November 17, 2020
• Primary Completion: April 3, 2023
• Study Completion: April 3, 2023
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)