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

This study has been terminated.
(Based in the negative of patients to shave de hair.)
Sponsor:
Information provided by (Responsible Party):
RAMON MONTES MOLINA, Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier:
NCT01308216
First received: March 3, 2011
Last updated: April 2, 2012
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Hemiplegia
Procedure: low level laser therapy procedure
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Transcranial Laser Therapy for Improving Upper Extremity Functional Recovery in Hemiplegic Patients From Ischemic Stroke

Resource links provided by NLM:


Further study details as provided by Hospital Universitario Ramon y Cajal:

Primary Outcome Measures:
  • Fugl-Meyer Scale [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Barthel index [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
    Barthel index (0-100) is composed of 10 items and assesses activities related to clothing,nourishment,personal hygiene and transference.


Enrollment: 25
Study Start Date: November 2010
Study Completion Date: December 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: COMBY 3 Terza Serie C-LASER; ASA.

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.

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01308216

Locations
Spain
Hospital Ramon y Cajal
Madrid, Spain, 28034
Sponsors and Collaborators
Hospital Universitario Ramon y Cajal
Investigators
Principal Investigator: Ramón Montes-Molina, PT Hospital University Ramon y Cajal. IRYCIS.Madrid
  More Information

No publications provided

Responsible Party: RAMON MONTES MOLINA, Physical Therapy, Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier: NCT01308216     History of Changes
Other Study ID Numbers: RyC-10
Study First Received: March 3, 2011
Last Updated: April 2, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Hospital Universitario Ramon y Cajal:
Transcranial Laser Therapy
Hemiplegia
Rehabilitation
Physiotherapy
Ischemic stroke

Additional relevant MeSH terms:
Hemiplegia
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014