Transcranial Laser Therapy in the Rehabilitation of Hemiplegic Patients From Ischemic Stroke

Study Overview
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Brief Summary
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The aim of this study is to determine the efficacy of transcranial laser therapy applied in automatic noncontact scanning mode for improving functional disability in patients with hemiplegia from ischemic stroke undergoing a rehabilitation program.

Detailed Description
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Transcranial laser therapy is applied with an InGa(Al)As diode laser.The laser in automatic scanning is applied over both cerebral hemisphere during 15 sessions. Patients simultaneously performed a program of therapeutic exercises 3 days a week. Outcome measures were the Fugl-Meyer Upper Extremity scale, which assessed upper limb motor function, and the Barthel index, which assessed general functional disability.

Official Title
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Efficacy of Transcranial Laser Therapy for Improving Upper Extremity Functional Recovery in Hemiplegic Patients From Ischemic Stroke

Conditions
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Hemiplegia

Intervention / Treatment
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* Procedure: low level laser therapy procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with hemiplegia secondary to cerebral stroke ischemic. Requirement of shaving the scalp area. Initiation of the TLT procedure begins between 70 and 100 days after stroke onset. Informed written consent before enrolling in the study. Exclusion Criteria: Hemiplegia secondary to hemorrhagic stroke. Metallic brain implants. Neurodegenerative disorders. Bilateral motor problems.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcranial low level laser therapy<br>Transcranial laser therapy is applied by automatic scanning over both hemispheres and the patients undergoing also a standard rehabilitation program based on therapeutic exercises. | Procedure: low level laser therapy procedure<br>* Transcranial low level laser therapy by automatic scanning noncontact over both cerebral hemispheres.<br>* Other names: COMBY 3 Terza Serie C-LASER; ASA.;|
| Active Comparator: Control<br>The patients undergoing only a standard rehabilitation program based on therapeutic exercises. | Procedure: low level laser therapy procedure<br>* Transcranial low level laser therapy by automatic scanning noncontact over both cerebral hemispheres.<br>* Other names: COMBY 3 Terza Serie C-LASER; ASA.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Scale | The upper extremity Fugl-Meyer subscale (0-66) considers flexor and extensor synegies as well as reflex activity and coordination and is specific for grading motor impairments. | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barthel index | Barthel index (0-100) is composed of 10 items and assesses activities related to clothing,nourishment,personal hygiene and transference. | 10 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcranial Laser Therapy, Hemiplegia, Rehabilitation, Physiotherapy, Ischemic stroke