Study Stopped
Based in the negative of patients to shave de hair.
Transcranial Laser Therapy in the Rehabilitation of Hemiplegic Patients From Ischemic Stroke
REHELA
Efficacy of Transcranial Laser Therapy for Improving Upper Extremity Functional Recovery in Hemiplegic Patients From Ischemic Stroke
1 other identifier
interventional
25
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Nov 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 3, 2011
CompletedFirst Posted
Study publicly available on registry
March 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedApril 3, 2012
November 1, 2011
10 months
March 3, 2011
April 2, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Barthel index
10 minutes
Study Arms (2)
Transcranial low level laser therapy
EXPERIMENTALTranscranial laser therapy is applied by automatic scanning over both hemispheres and the patients undergoing also a standard rehabilitation program based on therapeutic exercises.
Control
ACTIVE COMPARATORThe patients undergoing only a standard rehabilitation program based on therapeutic exercises.
Interventions
Transcranial low level laser therapy by automatic scanning noncontact over both cerebral hemispheres.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Hemiplegia secondary to hemorrhagic stroke.
- Metallic brain implants.
- Neurodegenerative disorders.
- Bilateral motor problems.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Ramon y Cajal
Madrid, Madrid, 28034, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ramón Montes-Molina, PT
Hospital University Ramon y Cajal. IRYCIS.Madrid
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physical Therapy
Study Record Dates
First Submitted
March 3, 2011
First Posted
March 4, 2011
Study Start
November 1, 2010
Primary Completion
September 1, 2011
Study Completion
December 1, 2011
Last Updated
April 3, 2012
Record last verified: 2011-11