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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-12-31

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.

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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.

Conditions

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Hemiplegia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Transcranial low level laser therapy

Transcranial laser therapy is applied by automatic scanning over both hemispheres and the patients undergoing also a standard rehabilitation program based on therapeutic exercises.

Group Type EXPERIMENTAL

low level laser therapy procedure

Intervention Type PROCEDURE

Transcranial low level laser therapy by automatic scanning noncontact over both cerebral hemispheres.

Control

The patients undergoing only a standard rehabilitation program based on therapeutic exercises.

Group Type ACTIVE_COMPARATOR

low level laser therapy procedure

Intervention Type PROCEDURE

Transcranial low level laser therapy by automatic scanning noncontact over both cerebral hemispheres.

Interventions

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low level laser therapy procedure

Transcranial low level laser therapy by automatic scanning noncontact over both cerebral hemispheres.

Intervention Type PROCEDURE

Other Intervention Names

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COMBY 3 Terza Serie C-LASER; ASA.

Eligibility Criteria

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Inclusion Criteria

1. Patients with hemiplegia secondary to cerebral stroke ischemic.
2. Requirement of shaving the scalp area.
3. Initiation of the TLT procedure begins between 70 and 100 days after stroke onset.
4. Informed written consent before enrolling in the study.