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

NCT05875116 | Recruiting DMC

• 1 other identifier: R 2016 3702 44
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke Sequelae

Keywords

Constraint-induced movement therapy; Hemiparesis; Neurorehabilitation; Satisfaction; Stroke; Virtual Reality

Outcome Measures

Primary Outcomes (6)

• 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).

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

• 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).

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

• 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).

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

• 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).

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

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

  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.

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

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

  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.

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

Secondary Outcomes (4)

• Level of aphasy to the 3 weeks of treatment.

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

• Level of aphasy to the 6 weeks of treatment.

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

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

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

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

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

Study Arms (3)

Group I: virtual reality activities

EXPERIMENTAL

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

Behavioral: Virtual reality

Group II: Modified Constraint-Induced Movement Therapy

EXPERIMENTAL

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.

Behavioral: Modified constraint-induced movement therapy

Group III: Usual Physical and Occupational Therapy

ACTIVE COMPARATOR

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

Behavioral: Usual Physical and Occupational Therapy

Interventions

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.

Group I: virtual reality activities

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.

Group II: Modified Constraint-Induced Movement Therapy

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.

Group III: Usual Physical and Occupational Therapy

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead

Study Sites (1)

Instituto Mexicano del Seguro Social

Mexico City, 06720, Mexico

RECRUITING

MeSH Terms

Conditions

Paresis; Personal Satisfaction; Stroke

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• María del Carmen Rojas-Sosa, Doctorado

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Garduño-Espinosa, Doctorado

CONTACT

55 5228 9917; juan.gardunoe@gmail.com

María del Carmen Rojas-Sosa, Doctorado

CONTACT

5521090980; mc_rojass@yahoo.com.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Clinical Trial Randomized Single Blind

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: May 25, 2023
• Study Start: August 17, 2018
• Primary Completion: August 21, 2024
• Study Completion: August 21, 2024
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)