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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-70
SponsorCoordinación de Investigación en Salud, Mexico

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Virtual reality

    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.

  • Modified constraint-induced movement therapy

    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.

  • Usual Physical and Occupational Therapy

    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.

Treatment groups

119 Participants
are divided into 3 treatment groups
Group A: Group I: virtual reality activitiesExperimental treatment 1 intervention
Group B: Group II: Modified Constraint-Induced Movement TherapyExperimental treatment 1 intervention
Group C: Group III: Usual Physical and Occupational TherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Functionality and disability of the paretic hemibody due to evento vascular cerebral (CVE) to the 3 weeks of treatment.

The motor functionality and disability of the paretic hemibody will be evaluated with Fugl-Meyer scale, it comprises 5 dominions y 113 total items that are scored on a 3 point ordinal scale (0= cannot perform, 1=perform partially, 2= perform fully). The individual scores are summed and the assessment can show a minimum value of 0 and a maximum value of 226 points, including 66 points for the upper extremity and 34 points for the lower extremity. A higher score represents better functionality of the hemibody (less disability).

Time frame
Fugl-Meyer scale will be administered at week 3 of follow-up (just after completing 6 rehabilitation sessions).
2

Functionality and disability of the paretic hemibody due to cerebro vascular event (CVE) to the 6 weeks of treatment.

The change in motor functionality and disability of the paretic hemibody will be evaluated with Fugl-Meyer scale, with 5 dominions y 113 total items that are scored on a 3 point ordinal scale (0= cannot perform, 1=perform partially, 2= perform fully). The individual scores are summed and the assessment can show a minimum value of 0 and a maximum value of 226 points, including 66 points for the upper extremity and 34 points for the lower extremity. Changes to higher score represents better functionality of the hemibody (less disability).

Time frame
The Fugl-Meyer scale will be administered at week 6 of follow-up (just after completing the 12 rehabilitation sessions).
3

Independency of patient with hemiparesis secondary to cerebro vascular event (CVE) to the 3 weeks of treatment.

The motor functionality and independency of patient with paretic hemibody will be evaluated with motor index scale, it comprises 3 dominions and 5 items (two for upper limb, one to hand -grip-, and two to lower limb). In each domain can be obtained a minimum value of 0 and a maximum value of 33 points, and 1 point is added to the sum of all of them for the total qualification. A higher qualification represents a better ability to carry out activities of daily human life (greater independency).

Time frame
Motor Index scale will be administered at week 3 of follow-up (just after completing 6 therapy sessions).
4

Independency of patient with hemiparesis secondary to cerebro vascular event (CVE) to the 6 weeks of treatment.

The motor functionality and independency of patient with paretic hemibody will be evaluated with motor index scale, it comprises 3 dominions and 5 items (two for upper limb, one to hand -grip-, and two to lower limb). In each domain can be obtained a minimum value of 0 and a maximum value of 33 points, and 1 point is added to the sum of all of them for the total qualification. Changes to higher qualification represents a better ability to carry out activities of daily human life (greater independency).

Time frame
The Motor Index scale will be administered at week 6 of follow-up (just after completing the 12 therapy sessions).

Secondary outcomes

1

Level of aphasy to the 3 weeks of treatment.

The quality of language will be evaluated with the Boston Aphasia Intensity scale in patients after cerebro vascular event (CVE). 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 (less aphasy).

Time frame
Boston Aphasia Intensity scale will be administered at week 3 of follow-up (just after completing 6 rehabilitation sessions).
2

Level of aphasy to the 6 weeks of treatment.

The quality of language will be evaluated with the Boston Aphasia Intensity scale in patients after cerebro vascular event (CVE). 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 (less aphasy).

Time frame
Boston Aphasia Intensity scale will be administered at week 6 of follow-up (just after completing 12rehabilitation sessions).
3

Level of patient satisfaction with treatment to the 3 weeks of treatment.

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. Score: from 1 (no satisfaction) to 7 (maximum satisfaction). A higher score represents a best level of satisfaction

Time frame
Intrinsic Motivation inventory will be administered at week 3 of follow-up (just after completing 6 rehabilitation sessions).
4

Level of patient satisfaction with treatment to the 6 weeks of treatment.

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. Score: from 1 (no satisfaction) to 7 (maximum satisfaction). A higher score represents a best level of satisfaction

Time frame
Intrinsic Motivation inventory will be administered at week 6 of follow-up (just after completing 12 rehabilitation sessions).

Other outcomes

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