Clinical trial NCT05875116: Virtual Reality Versus Constraint-induced Movement on Hemiparesis in Cerebrovascular Event
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke Sequelae
Keywords: Constraint-induced movement therapy
Hemiparesis
Neurorehabilitation
Satisfaction
Stroke
Virtual Reality
Lead sponsor: Coordinación de Investigación en Salud, Mexico
Sponsor class: OTHER_GOV
First posted: 2023-05-25
Enrollment: 119
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinical Trial Randomized Single Blind
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Functionality and disability of the paretic hemibody due to evento vascular cerebral (CVE) to the 3 weeks of treatment.
timeFrame: Fugl-Meyer scale will be administered at week 3 of follow-up (just after completing 6 rehabilitation sessions).
measure: Functionality and disability of the paretic hemibody due to cerebro vascular event (CVE) to the 6 weeks of treatment.
timeFrame: The Fugl-Meyer scale will be administered at week 6 of follow-up (just after completing the 12 rehabilitation sessions).
measure: Independency of patient with hemiparesis secondary to cerebro vascular event (CVE) to the 3 weeks of treatment.
timeFrame: Motor Index scale will be administered at week 3 of follow-up (just after completing 6 therapy sessions).
measure: Independency of patient with hemiparesis secondary to cerebro vascular event (CVE) to the 6 weeks of treatment.
timeFrame: The Motor Index scale will be administered at week 6 of follow-up (just after completing the 12 therapy sessions).
measure: Realization of the fine clamp of the plegia hand due to cerebro vascular event (CVE) to the 3 weeks of treatment.
timeFrame: Fine clamp test will be administered at week 3 of follow-up (just after completing 6 therapy sessions).
measure: Realization of fine clamp of the plegia hand due to cerebro vascular event (CVE) to the 6 weeks of treatment.
timeFrame: Fine clamp test will be administered at week 6 of follow-up (just after completing 12 therapy sessions).
Secondary outcomes:
measure: Level of aphasy to the 3 weeks of treatment.
timeFrame: Boston Aphasia Intensity scale will be administered at week 3 of follow-up (just after completing 6 rehabilitation sessions).
measure: Level of aphasy to the 6 weeks of treatment.
timeFrame: Boston Aphasia Intensity scale will be administered at week 6 of follow-up (just after completing 12rehabilitation sessions).
measure: Level of patient satisfaction with treatment to the 3 weeks of treatment.
timeFrame: Intrinsic Motivation inventory will be administered at week 3 of follow-up (just after completing 6 rehabilitation sessions).
measure: Level of patient satisfaction with treatment to the 6 weeks of treatment.
timeFrame: Intrinsic Motivation inventory will be administered at week 6 of follow-up (just after completing 12 rehabilitation sessions).
Other outcomes:
Locations:
city: Ciudad de México
country: Mexico
facility: Instituto Mexicano del Seguro Social
Study officials:
affiliation: Instituto Mexicano del Seguro Social
name: María del Carmen Rojas-Sosa, Doctorado
role: PRINCIPAL_INVESTIGATOR
References: