Efficacy of Modified FUT Protocols in Relation to CR Protocol

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: Classical kinesiotherapy.; Device: Tubular mesh.

• Registration Number: NCT02441374
• Lead Sponsor: University of Sao Paulo

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.

Study Timeline

• Study First Submitted: 2015-04-09
• Study First Submitted QC: 2015-05-07
• Study First Posted: 2015-05-12
• Study Start: 2016-08
• Primary Completion: 2017-05
• Study Completion: 2019-01
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-28
• Last Update Posted: 2019-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Classical Kinesiotherapy	Classical kinesiotherapy.	Rehabilitation of classical kinesiotherapy,at least 2 times a week for 4 weeks.
Forced Use Therapy	Tubular mesh.	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.

Primary Outcome Measures

Name	Time	Method
Evaluation of RMS activity through surface electromyography.	4 months	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

Name	Time	Method
Evaluate the strength handgrip (Kgf) of hemiparetic patients submitted to FUT post stroke.	4 months	Evaluations shall be performed weekly during the treatment period and 1 monthly assessment for 3 months after the protocol without therapeutic intervention.

Trial Locations

Locations (1)

Tamyris Padovani dos Santos; 🇧🇷 Ribeirão Preto, SP, Brazil