- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03811613
Photobiomodulation and Parkinson
Photobiomodulation in Parkinson´s Disease: A Randomized Controlled Trial.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Asturias
-
Oviedo, Asturias, Spain, 33005
- University School of Sports Medicine, University of Oviedo, Spain.
-
-
Castilla y León
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León, Castilla y León, Spain, 24071
- Department of Physical Education and Sport, University of León
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Having been diagnosed with idiopathic PD.
- Stage 1-2 on the Hoehn and Yahr Scale.
- Having no neurological condition other than PD.
- Being able to stand for 2 minutes and walk 10 meters without assistance.
- Having no severe dyskinesias or "ON-OFF" phases.
Exclusion Criteria:
- Do not follow inclusion criteria.
Study Plan
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: Photobiomodulation group
17 Parkinson´s disease patients were randomly assigned to the photobiomodulation group (experimental group). Intervention: Photobiomodulation was administered using red light-emitting diodes (LEDs) with a 670-nm wavelength in six 1-minute blocks alternating the LEDs between the right and left temples, with a 30-second rest between blocks. |
Photobiomodulation was administered using red light-emitting diodes (LEDs) with a 670-nm wavelength (which has proven to penetrate the skull)
Other Names:
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|
Sham Comparator: Sham group
18 Parkinson´s disease patients were randomly assigned to the sham group. Intervention: Procedures for the sham group were identical as the photobiomodulation one, except that patients received photobiomodulation during only 5 seconds followed by 55 seconds with no treatment (equalling 1/12th of the energy used for the intervention group). |
Photobiomodulation was administered using red light-emitting diodes (LEDs) with a 670-nm wavelength (which has proven to penetrate the skull)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The motor portion of the MDS-UPDRS.
Time Frame: 9 weeks
|
The motor portion (part III) Movement Disorders Society-Unified PD Rating Scale.
It assesses the motor signs of Parkinson´s disease (minimum and maximum score is 0 and 76 points respectively -the higher score, the higher movement disorder and vice versa-).
|
9 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Motor function
Time Frame: 9 weeks
|
The Spanish-validated version of the Short Parkinson's Evaluation Scale (SPES)/Scales for Outcomes in PD (SCOPA).
It measures the Parkinson´s disease patients motor function (minimum and maximum score is 0 and 63 points respectively -the higher score, the worse motor function and vice versa-).
|
9 weeks
|
|
Static posturography
Time Frame: 9 weeks
|
The centre of pressure (CoP) parameters (these CoP parameters; Length in mm, Area in mm2 and Speed in m/s are combined to report the static posturography).
|
9 weeks
|
|
Walking speed
Time Frame: 9 weeks
|
Ten-meter walk test
|
9 weeks
|
|
TUG
Time Frame: 9 weeks
|
Timed up and go test
|
9 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Luis Santos, PhD, Department of Physical Education and Sport (University of León, Spain)
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- #08/18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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