Effects of the association of an Intensive Physical and Behavioral Therapy and the Feedback of Movement Imagination on the functionality of the severely upper limb affected by Stroke: a clinical, controlled, randomized and blinded trial

Not Applicable

Recruiting

• Conditions: pper Extremity

• Registration Number: RBR-72vws64
• Lead Sponsor: niversidade Cidade de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-11-14
• Last Update Posted: 29 May 2023
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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