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

L

Lorena Aguilar Cano

Status

Completed

Conditions

Subacute Stroke

Treatments

Device: Virtual therapy
Other: Usual treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT06720194
RVACV2020

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

18 participants in 2 patient groups

Experimental group
Experimental group
Description:
This arm receives the virtual therapy plus the usual treatment
Treatment:
Device: Virtual therapy
Control Group
Other group
Description:
This arm receives the usual treatment at the same dose and time than experimental group
Treatment:
Other: Usual treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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