Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05875116

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Stroke Sequelae Behavior Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Neurologic Manifestations Paresis Pathological Conditions, Signs and Symptoms Personal Satisfaction Signs and Symptoms Stroke Vascular Diseases

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

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

    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).

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

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

    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).

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

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

    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).

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

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

    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).

  5. Realization of the fine clamp of the plegia hand due to cerebro vascular event (CVE) to the 3 weeks of treatment.

    Time frame: Fine clamp test will be administered at week 3 of follow-up (just after completing 6 therapy sessions).

    The realization of grip of the plegia hand will be evaluated with the fine clamp test, it comprises three action for cubes take of size different (score: 0- inability to take the cube, 1- Grab with your whole hand, 2- Radial clamp or 3 finger clamp and 3- Forefinger thumb clamp). The total qualification 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.

  6. Realization of fine clamp of the plegia hand due to cerebro vascular event (CVE) to the 6 weeks of treatment.

    Time frame: Fine clamp test will be administered at week 6 of follow-up (just after completing 12 therapy sessions).

    The realization of grip of the plegia hand will be evaluated with the fine clamp test, it comprises three action for cubes take of size different (score: 0- inability to take the cube, 1- Grab with your whole hand, 2- Radial clamp or 3 finger clamp, and 3- Forefinger thumb clamp). The total qualification 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 outcomes

  1. Level of aphasy to the 3 weeks of treatment.

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

    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).

  2. Level of aphasy to the 6 weeks of treatment.

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

    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).

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

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

    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

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

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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Juan Garduño-Espinosa, Doctorado

CONTACT

[email protected]

55 5228 9917 ext. 4314

María del Carmen Rojas-Sosa, Doctorado

CONTACT

[email protected]

5521090980

Sponsors and collaborators

Lead sponsor

Coordinación de Investigación en Salud, Mexico

Other Gov

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
May 25, 2023
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.