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

NCT ID: NCT05875116

Last Updated: 2024-08-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-17
• Study Completion Date: 2024-08-21

Brief 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.

Detailed 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.

Conditions

Stroke Sequelae

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group I: virtual reality activities

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

Group Type: EXPERIMENTAL

Virtual reality

Intervention Type: BEHAVIORAL

The activities will be carried out with the Virtual Reality team, for 1 hour, twice a week, for 12 sessions (6 weeks). It will be indicated to repeat the activities at home, on similar equipment and with the same or similar software, at least 1 hour a day, at least 3 days a week.

Group II: Modified Constraint-Induced Movement Therapy

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.

Group Type: EXPERIMENTAL

Modified constraint-induced movement therapy

Intervention Type: BEHAVIORAL

Physical and occupational therapy activities will be carried out with the paretic upper limb, while the patient has the healthy upper limb "attached to the chest", for 1 hour, twice a week, for 12 sessions (6 weeks). It will be indicated to repeat the activities at home, 1 hour a day, at least 3 days a week. In addition, the participant will perform activities of daily living with the "free" paretic arm and the "fixed" healthy arm, for 5 hours a day.

Group III: Usual Physical and Occupational Therapy

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

Group Type: ACTIVE_COMPARATOR

Usual Physical and Occupational Therapy

Intervention Type: BEHAVIORAL

The physical and occupational therapy activities that are usually practiced in the Medical Unit will be carried out for 1 hour, twice a week, for 12 sessions (6 weeks). It will be indicated to repeat the activities at home, for 1 hour a day, at least 3 days a week.

Interventions

Virtual reality

The activities will be carried out with the Virtual Reality team, for 1 hour, twice a week, for 12 sessions (6 weeks). It will be indicated to repeat the activities at home, on similar equipment and with the same or similar software, at least 1 hour a day, at least 3 days a week.

Intervention Type: BEHAVIORAL

Modified constraint-induced movement therapy

Physical and occupational therapy activities will be carried out with the paretic upper limb, while the patient has the healthy upper limb "attached to the chest", for 1 hour, twice a week, for 12 sessions (6 weeks). It will be indicated to repeat the activities at home, 1 hour a day, at least 3 days a week. In addition, the participant will perform activities of daily living with the "free" paretic arm and the "fixed" healthy arm, for 5 hours a day.

Intervention Type: BEHAVIORAL

Usual Physical and Occupational Therapy

The physical and occupational therapy activities that are usually practiced in the Medical Unit will be carried out for 1 hour, twice a week, for 12 sessions (6 weeks). It will be indicated to repeat the activities at home, for 1 hour a day, at least 3 days a week.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Coordinación de Investigación en Salud, Mexico

OTHER_GOV

Sponsor Role: lead

Responsible Party

María del Carmen Rojas-Sosa

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

María del Carmen Rojas-Sosa, Doctorado

Role: PRINCIPAL_INVESTIGATOR

Instituto Mexicano del Seguro Social

Locations

Instituto Mexicano del Seguro Social

Mexico City, , Mexico

Site Status: RECRUITING

Countries

Mexico

Central Contacts

Juan Garduño-Espinosa, Doctorado

Role: CONTACT

juan.gardunoe@gmail.com

55 5228 9917 ext. 4314

María del Carmen Rojas-Sosa, Doctorado

Role: CONTACT

mc_rojass@yahoo.com.mx

5521090980

Facility Contacts

Jaime Alfredo Castellanos Romero

Role: primary

jaime.castellanos@imss.gob.mx

55 5684 1274

María del Carmen Mora Rojas

Role: backup

carmen.morar@imss.gob.mx

55 5684 1274

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

R 2016 3702 44

Identifier Type: -

Identifier Source: org_study_id