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

April 2, 2012 updated by: RAMON MONTES MOLINA, Hospital Universitario Ramon y Cajal

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28034
        • Hospital Ramón y Cajal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Exclusion Criteria:

  1. Hemiplegia secondary to hemorrhagic stroke.
  2. Metallic brain implants.
  3. Neurodegenerative disorders.
  4. Bilateral motor problems.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: low level laser therapy procedure
Transcranial low level laser therapy by automatic scanning noncontact over both cerebral hemispheres.
Other Names:
  • COMBY 3 Terza Serie C-LASER; ASA.
Active Comparator: Control
The patients undergoing only a standard rehabilitation program based on therapeutic exercises.
Procedure: low level laser therapy procedure
Transcranial low level laser therapy by automatic scanning noncontact over both cerebral hemispheres.
Other Names:
  • COMBY 3 Terza Serie C-LASER; ASA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Scale
Time Frame: 20 minutes
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
Time Frame: 10 minutes
Barthel index (0-100) is composed of 10 items and assesses activities related to clothing,nourishment,personal hygiene and transference.
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Ramon y Cajal

Investigators

  • Principal Investigator: Ramón Montes-Molina, PT, Hospital University Ramon y Cajal. IRYCIS.Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

March 3, 2011

First Submitted That Met QC Criteria

March 3, 2011

First Posted (Estimate)

March 4, 2011

Study Record Updates

Last Update Posted (Estimate)

April 3, 2012

Last Update Submitted That Met QC Criteria

April 2, 2012

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RyC-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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