Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05875116
Status:
RECRUITING
Last Update Posted:
2023-08-30
First Post:
2023-05-03
Brief Title:
Virtual Reality Versus Constraint-induced Movement on Hemiparesis in Cerebrovascular Event
Sponsor:
Coordinación de Investigación en Salud Mexico
Organization:
Coordinación de Investigación en Salud Mexico
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 -AI- during intermediate assessment -IntA- week 3 session 6 and after final assessment -FA - 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
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 -AI- during intermediate assessment -IntA- week 3 session 6 and after final assessment -FA - 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None