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Efficacy of Modified FUT Protocols in Relation to CR Protocol

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Tubular mesh.
Classical kinesiotherapy.
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Hemiparesis, Upper limb

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Good cognition,
  2. Absence of joint blocks,
  3. Good range of motion in upper limb with at least 20º of active extension of the wrist and 10º in the metacarpal phalangeal,
  4. Joint and walking capacity without assistance.

Exclusion Criteria:

  1. Heart arrhythmia,
  2. Hypertension,
  3. Severe cardiovascular and respiratory problems,
  4. Inability to attend the sessions.

Sites / Locations

  • Tamyris Padovani dos Santos

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Forced Use Therapy

Classical Kinesiotherapy

Arm Description

Constriction (through the tubular mesh) of non paretic upper limb for a period of 12 and 24 hours, 5 days per week for 4 weeks.

Rehabilitation of classical kinesiotherapy,at least 2 times a week for 4 weeks.

Outcomes

Primary Outcome Measures

Evaluation of RMS activity through surface electromyography.
Evaluations shall be performed weekly during the treatment period and 1 monthly assessment for 3 months after the protocol without therapeutic intervention.

Secondary Outcome Measures

Evaluate the strength handgrip (Kgf) of hemiparetic patients submitted to FUT post stroke.
Evaluations shall be performed weekly during the treatment period and 1 monthly assessment for 3 months after the protocol without therapeutic intervention.

Full Information

First Posted
April 9, 2015
Last Updated
August 28, 2019
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02441374
Brief Title
Efficacy of Modified FUT Protocols in Relation to CR Protocol
Official Title
Efficacy of Modified FUT Protocols With 12 and 24 Hours of Upper Limb Immobilization in Relation to CR Arm Protocol.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
January 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
There are some treatments after Stroke. Among these, use forced therapy (FUT), which is based on overcoming learned disuse by reintroduction of the paretic upper limb in the performance of daily activities. There are different protocols FUT to the daily time constraint, the number of days and even the type of constriction. Researchers have developed a protocol using four weeks constriction, daily constriction 24 hours and with the free end of the weekends. Because it is a restrictive therapy, which requires the use of one of the arms and on the other hand, this mode of treatment is open to criticism, however, despite the efficacy of the protocol, patients do not have good adhesion to the protocol for the constriction severe over time. The objective of this work is to verify the safety of the developed protocol and analyze the feasibility of reducing the daily time of constriction 12 hours, with a new protocol movement constriction, easier to perform and more patient acceptance. Participate in this study 82 individuals hemiparetic post Stroke, which will be recruited to Neurovascular Diseases Clinic and will be registered at the Rehabilitation Center of Integrated State Hospital. Participants will be randomly divided into three groups: the FUT24 (non-paretic upper limb constriction 24 hours a day, five days a week for 4 weeks), the FUT 12 (non-paretic upper limb constriction for 12 hours a day, five days a week for 4 weeks) and CK (Classic Kinesiotherapy, at least 2 times a week for 4 weeks). Will be held weekly and after the end of the monthly monitoring reviews protocols. For the rating scales are use: National Institute of Health Stroke Scale, the Ashworth Scale, the Wolf Motor Function Test, the Motor Activity Log, Fugl-Meyer Assesment, dynamometry handgrip and surface electromyography (flexor and extensor muscles wrist). The researchers hope that this protocol does not bring damage to the upper limb in constriction and it is established a new protocol FUT easier to perform and more acceptable to patients, allowing the use of this technique by health professionals.
Detailed Description
The constriction of the non-paretic upper limb will be conducted through a tubular mesh with UL positioned in adduction and shoulder internal rotation and elbow flexion greater than 90º in FUT 24 and FUT 12 groups. Daily, the mesh is withdrawn by the investigators made hygienic, and the new constraint is accomplished using a new tubular mesh.The Classic Kinesiotherapy Group,which will receive as a treatment only kinesiotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Hemiparesis, Upper limb

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Forced Use Therapy
Arm Type
Experimental
Arm Description
Constriction (through the tubular mesh) of non paretic upper limb for a period of 12 and 24 hours, 5 days per week for 4 weeks.
Arm Title
Classical Kinesiotherapy
Arm Type
Active Comparator
Arm Description
Rehabilitation of classical kinesiotherapy,at least 2 times a week for 4 weeks.
Intervention Type
Device
Intervention Name(s)
Tubular mesh.
Intervention Description
Rehabilitation in upper limb during and after applying of FUT (through the tubular mesh) post stroke.
Intervention Type
Other
Intervention Name(s)
Classical kinesiotherapy.
Intervention Description
Applying classical kinesiotherapy in upper limb post stroke.
Primary Outcome Measure Information:
Title
Evaluation of RMS activity through surface electromyography.
Description
Evaluations shall be performed weekly during the treatment period and 1 monthly assessment for 3 months after the protocol without therapeutic intervention.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Evaluate the strength handgrip (Kgf) of hemiparetic patients submitted to FUT post stroke.
Description
Evaluations shall be performed weekly during the treatment period and 1 monthly assessment for 3 months after the protocol without therapeutic intervention.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Good cognition, Absence of joint blocks, Good range of motion in upper limb with at least 20º of active extension of the wrist and 10º in the metacarpal phalangeal, Joint and walking capacity without assistance. Exclusion Criteria: Heart arrhythmia, Hypertension, Severe cardiovascular and respiratory problems, Inability to attend the sessions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamyris Padovani dos Santos
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tamyris Padovani dos Santos
City
Ribeirão Preto
State/Province
SP
ZIP/Postal Code
14026514
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
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Efficacy of Modified FUT Protocols in Relation to CR Protocol

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