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

Coordinación de Investigación en Salud, Mexico

Status: Enrolling

Conditions: Stroke Sequelae

Treatments: Behavioral: Usual Physical and Occupational Therapy; Behavioral: Virtual reality; Behavioral: Modified constraint-induced movement therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05875116

R 2016 3702 44

Details and patient eligibility

About

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.

Full 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.

Enrollment: 119 estimated patients

Sex: All

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients between 35 and 70 years of age and with a clinically and tomographically proven diagnosis of a cerebral vascular event in the territory of the middle cerebral artery.
• Patients with hemiparesis secondary to the cerebrovascular event
• Patients with a maximum Ashworth of 2 and Brunnstrom of minimum 4
• Patients with or without aphasia
• Patients with evolution between 1 to 3 months from hospital discharge of the cerebrovascular event
• Patients with cerebrovascular event of any sex
• Patients with vascular event without cognitive deficit
• Patients who agree to participate by signing an informed consent, by them or their family member or person in charge.

Exclusion criteria

• Patients who develop dementia or neurological-psychomotor complications during the study.
• Patients who present a new cerebrovascular event during the investigation
• Patients who do not complete at least 90% of the program
• Patients in whom a lack of family support or secondary gain is detected.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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119 participants in 3 patient groups

Group I: virtual reality activities

Experimental group

Description:

The patient will practice the corresponding activities of the software indicated in the virtual reality equipment.

Treatment:

Behavioral: Virtual reality

Group II: Modified Constraint-Induced Movement Therapy

Experimental group

Description:

Patients will have the "healthy" upper limb fixed to the thorax with a sling and a horizontal shoulder immobilizer; The participants will practice physical and occupational therapy activities with the paretic upper limb.

Treatment:

Behavioral: Modified constraint-induced movement therapy

Group III: Usual Physical and Occupational Therapy

Active Comparator group

Description:

The participants will practice physical and occupational therapy activities that are usually provided in the Medical Unit, without any restrictions on the upper extremities.

Treatment:

Behavioral: Usual Physical and Occupational Therapy