Upper Extremity
Conditions
Interventions
This is a randomized controlled clinical trial with three arms (total sample= 54 individuals). Constraint-induced therapy experimental group: 18 individuals diagnosed with stroke and severe upper limb
Sponsors
Universidade Cidade de São Paulo
Associação de Assistência a Criança Deficiente
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Stroke more than six months before the beginning of the protocol; age between 18 and 80 years; hemiparesis as a sequela of stroke; score on the Fugl Meyer scale for the upper extremity =53 points (moderate and severe injuries), but present at least 30º of shoulder flexion and/or abduction and 10º of elbow extension (from 90º flexion), as well as, greater impairment in the hand most affected by the stroke, evidenced by the deficit in the active extension of the fingers of the hand most affected by the stroke (towel test: should not be able to pick up a face towel from a table and release it more than three times in a minute ); finger flexor tone of the most affected hand <3, assessed by the Modified Ashworth scale; ability to understand simple commands and instructions for assessments and intervention protocols; be available to attend assessments and therapy for 15 consecutive days and remain 3 hours/day in treatment
Exclusion criteria
Exclusion criteria: Inability to interrupt other physical therapies during intervention protocols; language alteration that makes the participant unable to understand, as well as respond appropriately to the proposed assessment scales, interaction with the brain-machine interface and the exercises selected for each protocol; surgery less than 6 months ago, chemical block in the upper limb most affected by stroke less than 3 months ago
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| With the primary outcome, it is intended to evaluate the improvement in the function and structure of the upper limb affected by stroke through the Fugl Meyer scale that has the domains of upper extremity (36 points), wrist (10 points), hand (14 points), coordination and movement speed (6 points), totaling 66 points with the inclusion of the reflex evaluation, and the minimum clinically significant change of this scale is 4.25-7.25 points, therefore it is expected that the experimental groups present a value minimum difference with the control group of 4.25 points | — |
Secondary
| Measure | Time frame |
|---|---|
| With the secundary outcome, it is intended to evaluate the improvement of activities performed with the upper limb affected by stroke through the Graded Wolf Motor Function Test, which has 10 activities in which the patient must perform as quickly as possible and with the best quality possible for up to 120 seconds, at the same time the evaluator is analyzing the quality of movement during the activities performed and scoring through the functional ability scale, which varies from 0 to 5 points, with 0 - when the individual refuses to perform the activity, 1 - when trying to perform but not completing the activity within the time, 2 - performing the activity with an inadequate movement pattern, primitive patterns, compensation in the requested movement or with the help of the least affected (poor) upper limb, 3 - performing the activity slower or with compensation to perform the requested movement, but in other body structures not directly involved in the requested activity (regular ), 4 - almost normal movement, only slower or with some imprecision (almost normal) and 5 - normal movement. It is expected that the experimental groups show a significant difference in relation to the control group (there are no clinical parameters such as minimal detectable change, nor clinically significant for this instrument) | — |
Countries
Brazil
Contacts
Public ContactGabriela Matuti
Associação de Assistência a Criança Deficiente
Outcome results
None listed