Efficacy of Modified FUT Protocols in Relation to CR Protocol

NCT02441374 | Completed

• 1 other identifier: TPSantos
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke; Hemiparesis; Upper limb

Outcome Measures

Primary Outcomes (1)

• 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.

  4 months

Secondary Outcomes (1)

• Evaluate the strength handgrip (Kgf) of hemiparetic patients submitted to FUT post stroke.

  4 months

Study Arms (2)

Forced Use Therapy

EXPERIMENTAL

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.

Device: Tubular mesh.

Classical Kinesiotherapy

ACTIVE COMPARATOR

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

Other: Classical kinesiotherapy.

Interventions

Tubular mesh. DEVICE

Rehabilitation in upper limb during and after applying of FUT (through the tubular mesh) post stroke.

Forced Use Therapy

Classical kinesiotherapy. OTHER

Applying classical kinesiotherapy in upper limb post stroke.

Classical Kinesiotherapy

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Heart arrhythmia,
• Hypertension,
• Severe cardiovascular and respiratory problems,
• Inability to attend the sessions.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Tamyris Padovani dos Santos

Ribeirão Preto, São Paulo, 14026514, Brazil

Location

Related Publications (20)

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MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

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

Study Officials

• Tamyris Padovani dos Santos

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: João Eduardo de Araujo

Study Record Dates

• First Submitted: April 9, 2015
• First Posted: May 12, 2015
• Study Start: August 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: January 1, 2019
• Last Updated: August 30, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)