Virtual Reality Versus Constraint-induced Movement on Hemiparesis in Cerebrovascular Event

Stroke Sequelae Clinical Trial

Official title: Effect of Different Therapeutic Modalities With Virtual Reality or Modified Constraint-induced Movement Therapy Compared With Usual Physical and Occupational Therapy on Motor Recovery of Paretic Limbs in Patients With Cerebrovascular Event

Status Recruiting

Clinical Trial Summary

The objective of this clinical trial is to measure the effect of Rehabilitation with Virtual Reality or Modified Constraint-Induced Movement Therapy on hemiparesis in patients with Cerebral Vascular Event.

The question to be answered is: What is the effect of different therapeutic modalities supported by Virtual Reality or Modified Constraint-Induced Movement Therapy compared with usual Physical and Occupational Therapy on motor recovery of paretic limbs in patients with Cerebrovascular Event?

The patients will carry out activities of:

• Virtual reality or

• Movement Restriction-Induction Therapy.

The investigators will compare the changes in the functionality of the paretic hemibody with a group undergoing regular physical and occupational therapy, as well as language and treatment-related satisfaction.

Clinical Trial Description

Patients with diagnosis of cerebrovascular event (CVE) will be recruited upon arrival at the Medical Unit in the first appointment area; The diagnosis will be verified and an appointment will be made to the office of one of the researchers -rehabilitation specialist- (evaluator 1). During the appointment the purpose of the study will be explained and doubts will be clarified. All participants, whether accept or not, will receive the consultation that is normally provided to these patients and the information will be recorded in the medical record. If the subject does not accept, after the consultation, the appropriate management for the condition will be prescribed and a subsequent appointment will be made with another corresponding doctor to continue with the control.

If the subject agrees to participate, a clinical summary will be prepared, which will include demographic data, employment situation, the need for temporary disability for work and clinical data for the research file. The signature of the informed consent letter will also be requested. This physician 1 will assign the therapeutic modality using a table of random numbers to: Group 1. Therapy supported by virtual reality; Group 2. Modified Constraint-Induced Movement Therapy; o Group 3. Usual physical and occupational therapy. The activities corresponding to each group will be carried out during 2 sessions a week, of 1 hour each session, for 6 weeks.

An appointment will be made to be assessed by the second rehabilitation specialist (evaluator 2), who will remain blind to the treatment, and will measure the functionality of the thoracic and pelvic limbs with the different scales (Fugl-Meyer, Motor Index and Fine Clamp Test), including muscle tone, trophism, arcs of mobility, functionality of the limbs, as well as of the hand, coordination, balance and sensory aspects. These scales will be applied before (initial assessment -A.I.-), during (intermediate assessment -Int.A.- week 3, session 6) and after (final assessment -F.A. - week 6, session 12) of the different rehabilitation programs. During the same times, the Boston Aphasia Intensity scale and the Intrinsic Motivation Inventory will be applied by a neuropsychologist blinded to the treatment, for the evaluation of language and satisfaction, respectively. ;

Related Conditions & MeSH terms

• Paresis
• Stroke Sequelae

• NCT number: NCT05875116
• Study type: Interventional
• Source: Coordinación de Investigación en Salud, Mexico
• Contact: Juan Garduño-Espinosa, Doctorado
• Phone: 55 5228 9917
• Email: juan.gardunoe@gmail.com
• Status: Recruiting
• Phase: N/A
• Start date: August 17, 2018
• Completion date: August 28, 2023