Back to resultsTranscranial Laser Therapy in the Rehabilitation of Hemiplegic Patients From Ischemic Stroke (REHELA)
Primary Purpose
Hemiplegia
Status
Terminated
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
low level laser therapy procedure
Sponsored by
About this trial
This is an interventional treatment trial for Hemiplegia focused on measuring Transcranial Laser Therapy, Hemiplegia, Rehabilitation, Physiotherapy, Ischemic stroke
Eligibility Criteria
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.
Sites / Locations
- Hospital Ramon y Cajal
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Transcranial low level laser therapy
Control
Arm Description
Transcranial laser therapy is applied by automatic scanning over both hemispheres and the patients undergoing also a standard rehabilitation program based on therapeutic exercises.
The patients undergoing only a standard rehabilitation program based on therapeutic exercises.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Barthel index
Barthel index (0-100) is composed of 10 items and assesses activities related to clothing,nourishment,personal hygiene and transference.
Full Information
NCT ID
NCT01308216
First Posted
March 3, 2011
Last Updated
April 2, 2012
Sponsor
Hospital Universitario Ramon y Cajal
1. Study Identification
Unique Protocol Identification Number
NCT01308216
Brief Title
Transcranial Laser Therapy in the Rehabilitation of Hemiplegic Patients From Ischemic Stroke
Acronym
REHELA
Official Title
Efficacy of Transcranial Laser Therapy for Improving Upper Extremity Functional Recovery in Hemiplegic Patients From Ischemic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Terminated
Why Stopped
Based in the negative of patients to shave de hair.
Study Start Date
November 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Ramon y Cajal
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia
Keywords
Transcranial Laser Therapy, Hemiplegia, Rehabilitation, Physiotherapy, Ischemic stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transcranial low level laser therapy
Arm Type
Experimental
Arm Description
Transcranial laser therapy is applied by automatic scanning over both hemispheres and the patients undergoing also a standard rehabilitation program based on therapeutic exercises.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
The patients undergoing only a standard rehabilitation program based on therapeutic exercises.
Intervention Type
Procedure
Intervention Name(s)
low level laser therapy procedure
Other Intervention Name(s)
COMBY 3 Terza Serie C-LASER; ASA.
Intervention Description
Transcranial low level laser therapy by automatic scanning noncontact over both cerebral hemispheres.
Primary Outcome Measure Information:
Title
Fugl-Meyer Scale
Description
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.
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
Barthel index
Description
Barthel index (0-100) is composed of 10 items and assesses activities related to clothing,nourishment,personal hygiene and transference.
Time Frame
10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramón Montes-Molina, PT
Organizational Affiliation
Hospital University Ramon y Cajal. IRYCIS.Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Transcranial Laser Therapy in the Rehabilitation of Hemiplegic Patients From Ischemic Stroke
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