Upper-limb Functional Recovery With Virtual Reality System (BTs-Nirvana) Associated With Conventional Therapy in Hospitalized Subacute Stroke Patients
NCT ID: NCT06720194
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
18 participants
INTERVENTIONAL
2020-11-17
2023-04-03
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental group
This arm receives the virtual therapy plus the usual treatment
Virtual therapy
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.
Control Group
This arm receives the usual treatment at the same dose and time than experimental group
Usual treatment
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.
Interventions
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Virtual therapy
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.
Usual treatment
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
OTHER
Lorena Aguilar Cano
OTHER
Responsible Party
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Lorena Aguilar Cano
Principal Investigator
Locations
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Hospital Universitario Regional de Malaga
Málaga, , Spain
Countries
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Other Identifiers
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RVACV2020
Identifier Type: -
Identifier Source: org_study_id