Virtual Reality Versus Restriction-induction of Movement on Hemiparesis in Cerebrovascular Event

Sponsor

Coordinación de Investigación en Salud, Mexico (Other)

Overall Status

Recruiting

CT.gov ID

NCT05875116

Collaborator

(none)

119

Enrollment

Location

Arms

62.1

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this clinical trial is to measure the effect of Rehabilitation with Virtual Reality or Restriction and Induction of Movement on hemiparesis in patients with a Cerebral Vascular Event.

The question to be answered is: What is the effect of different therapeutic modalities supported by Virtual Reality or Restriction and Induction of Movement 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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Sequelae	Behavioral: Virtual reality Behavioral: Modified Movement Induction Restraint Therapy Behavioral: Usual Physical and Occupational Therapy	N/A

Detailed Description

Patients with a diagnosis of cerebrovascular event (CVE) will be recruited upon arrival at the Medical Unit in the first-time appointment area; the delivery diagnosis will be verified and an appointment will be made to the consulting room 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. Whether they accept or not, the patient will receive the consultation that is normally provided to this type of patient and the information will be recorded in the clinical record. If you do not accept, after the consultation, the appropriate management for your condition will be prescribed and a subsequent appointment will be made with the corresponding doctor to continue your control.

If you agree to participate, a clinical summary will be prepared, which includes demographic data, whether you are a worker or not, 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 performed the assignment to the therapeutic modality using a table of random numbers to: Group 1. Therapy supported by virtual reality; Group 2. Therapy supported by restriction and induction of movement; 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. . At the same times, the Boston Aphasia Intensity scale and the Intrinsic Motivation Inventory will be used by a neuropsychologist blinded to treatment.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

119 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Clinical Trial Randomized Single BlindClinical Trial Randomized Single Blind

Masking:

Single (Outcomes Assessor)

Masking Description:

The evaluators were blinded to the therapy group to which the patient belonged. The patient, family member or person in charge was instructed not to comment on their management or activities they carried out, only to carry out the activities indicated by the evaluator during the review.

Primary Purpose:

Treatment

Official Title:

Effect of Different Therapeutic Modalities With Virtual Reality or Movement Restriction-induction Compared With Usual Physical and Occupational Therapy on Motor Recovery of Paretic Limbs in Patients With Cerebrovascular Event

Actual Study Start Date :

Mar 14, 2018

Actual Primary Completion Date :

May 16, 2023

Anticipated Study Completion Date :

May 16, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group I: virtual reality activities The patient will carry out the corresponding activities of the software indicated in the virtual reality equipment.	Behavioral: 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.
Experimental: Group II: Modified Movement Induction Restraint Therapy The patient will have the "healthy" upper limb fixed with a sling and bra and will perform physical and occupational therapy activities with the paretic upper limb.	Behavioral: Modified Movement Induction Restraint 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, you will perform activities of daily living with the "free" paretic arm and the "fixed" healthy arm, for 5 hours a day.
Active Comparator: Group III: Usual Physical and Occupational Therapy The patient will carry out the physical and occupational therapy activities that are usually provided in the Medical Unit.	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.

Arm

Intervention/Treatment

Experimental: Group I: virtual reality activities

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

Behavioral: 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.

Experimental: Group II: Modified Movement Induction Restraint Therapy

The patient will have the "healthy" upper limb fixed with a sling and bra and will perform physical and occupational therapy activities with the paretic upper limb.

Behavioral: Modified Movement Induction Restraint 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, you will perform activities of daily living with the "free" paretic arm and the "fixed" healthy arm, for 5 hours a day.

Active Comparator: Group III: Usual Physical and Occupational Therapy

The patient will carry out the physical and occupational therapy activities that are usually provided in the Medical Unit.

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.

Outcome Measures

Primary Outcome Measures

Functionality and disability. Changes in hemiparesis secondary to CVE after neurorehabilitation in the 3 different groups. [Six weeks (total treatment time): the scale will be applied before treatment, at 6 sessions (3 weeks) and at the end of session 12 (6 weeks).]
The motor functionality of the paretic hemibody secondary to CVE will be evaluated in each of the 3 groups, with 3 scales, the first: Fugl-Meyer scale: the assessment can show a minimum value of 0 and a maximum value of 226 points. A higher score represents better functionality of the hemibody (less disability).
Functionality and independence. Changes in hemiparesis secondary to CVE after neurorehabilitation in the 3 different groups. [Six weeks (total treatment time): the scale will be applied after the Fugl Meyer scale, at the same times,before treatment, at 6 sessions (3 weeks) and at the end of session 12 (6 weeks).]
The motor functionality of the paretic hemibody secondary to CVE will be evaluated in each of the 3 groups, with 3 scales, the second: Motor index scale: the assessment can show a minimum value of 0 and a maximum value of 100 points. A higher qualification represents a better ability to carry out activities of daily human life (greater independence).
Functionality of fine clamp of hand. Changes in hemiparesis secondary to CVE after neurorehabilitation in the 3 different groups. [Six weeks (total treatment time): the fine clamp test will be applied after motor index, before treatment, at 6 sessions (3 weeks) and at the end of session 12 (6 weeks).]
The motor functionality of the paretic hemibody secondary to CVE will be evaluated in each of the 3 groups, specifically assessing the plegia hand, with the following scale: Fine clamp test: the result has a minimum value of 0 and a maximum value of 9 points. A higher score represents a better performance of the clamp between the index finger and thumb of the paralyzed hand.

Secondary Outcome Measures

Language quality. Changes in aphasia secondary to CVE, in the 3 different groups. [In the six weeks of treatment, the scales will be applied before therapy, at 6 sessions (3 weeks) and at the end of session 12 (6 weeks).]
The quality of language will be evaluated with the Boston Aphasia Intensity scale in the patients of the three treatment groups. In the Boston Aphasia Intensity scale the result has a minimum value of 0 and a maximum value of 5 points. A higher score represents a better language quality.
Evaluation of perceived satisfaction by patient with the treatment, in the 3 different groups. [Six weeks (total treatment time): the Intrinsic Motivation inventory will be applied, at the same times that other scales: before therapy, at 6 sessions (3 weeks) and at the end of session 12 (6 weeks).]
The satisfaction reported by the patient with the treatment received will be evaluated, with the Intrinsic Motivation inventory. In the Intrinsic Motivation inventory the result has a minimum value of 22 and a maximum value of 154 points. A higher score represents a best level of satisfaction

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.