Determine the impact of circadian rhythms modulation by timed exposure to bright light (TEBL) on improving anticipatory postural adjustment (APA) during self-initiated gait in medicated PD patients.
Determine the impact of circadian rhythms modulation by timed exposure to bright light (TEBL) on anticipatory postural adjustment (APA) responses to auditory and visual cues during gait initiation in medicated PD patients.
Design
To carry out this project, the participant will be randomly and double blinded placed in one of the study groups (A or B).
Settings and conduct
the volunteer is invited to participate in the test session at Javad Mofafgian Smart Neurorehabilitation Technologies Research Center.
Blinding in this study is done in such a way that the patient receives glasses (intervention or comparison group) in coded packages. Coding is done by one of the colleagues of the project and the doctor, evaluator and patient are blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria for patients with Parkinson's disease in this study, idiopathic Parkinson's disease diagnosed by a neurologist, stage 2 or 3 disease according to the Hoehn and Yahr scale, and walking ability. Walking independently without the need for mobility aids (such as canes and walkers) for 30 minutes.
Intervention groups
People in both control and intervention experimental groups will wear glasses for two weeks. Participants receiving the placebo glasses will be asked to wear the red light glasses every night (two hours before bedtime) for one hour.
The effect of circadian rhythms modulation on anticipatory postural adjustments for gait initiation in people with Parkinson’s disease
Public title
The effect of circadian rhythms modulation for gait initiation in people with Parkinson’s disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 40 and 75 years.
Idiopathic Parkinson's disease diagnosed by a neurologist.
Being in stages 2 and 3 of the disease based on the Hoehn and Yahr scale.
The ability to walk independently without the need for mobility aids (such as canes and walkers) for 30 minutes.
Exclusion criteria:
Presence of accompanying neurological disorders or history of other neurological disorders or major psychiatric illness.
The presence of cognitive disorders affecting the study.
Drug and alcohol addiction.
The presence of vision and hearing problems, which affect the patient's ability to perform the test correctly.
The presence of sensory problems in the legs or musculoskeletal disorders in the lower limbs.
Suffering from chronic back pain and the presence of a prosthesis in the lower limb that limits the range of movements.
Having severe tremors, a score greater than 2 on any of the items 3.15a to 3.17e on the clinical test (MDS-UPDRS).
History of episodes of freezing of gait or dyskinesia
History of implant surgery (Deep brain stimulation or DBS)
Age
From 40 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data and Safety Monitoring Board
Sample size
Target sample size:
16
Randomization (investigator's opinion)
Randomized
Randomization description
The use of lottery in this study is chosen for random sampling. The researcher will give each member of the community a special code. Therefore, there will be a numbered paper at the disposal of the researcher as many people as there are in the community. Then he pours them into a bag or container and stirs them. Then he takes out the beads one by one, notes their number and they are placed in the intervention and control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients (intervention or comparison group) in code packages
are received. Coding by one of the project collaborators
It takes place and the doctor, evaluator and patient are blinded.
Placebo
Used
Assignment
Crossover
Other design features
In the cross-over design, each candidate receives all the interventions of the study in consecutive periods, and each participant is his OR her own witness (control). Which participant will receive one of the interventions in the first or second phase is randomly determined based on the random placement of the participant in group A or group B. Thus, each patient should participate in the tests for four sessions.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2022-12-14, 1401/09/23
Ethics committee reference number
IR.IUMS.REC.1401.715
Health conditions studied
1
Description of health condition studied
Parkinson disease
ICD-10 code
G20
ICD-10 code description
Parkinson's disease
Primary outcomes
1
Description
Circadian rhythms function
Timepoint
Measurements will be taken before using the glasses and 14 days after using the glasses.
Method of measurement
Examining the daily sleep pattern
2
Description
Anticipatory postural adjustment
Timepoint
Measurements will be taken before using the glasses and 14 days after using the glasses.
Method of measurement
Gait analysis and Electromyography indicators
3
Description
Gait initiation
Timepoint
Measurements will be taken before using the glasses and 14 days after using the glasses.
Method of measurement
Gait analysis and Electromyography indicators
4
Description
Severity of Parkinson's disease
Timepoint
Measurements will be taken before using the glasses and 14 days after using the glasses.
Method of measurement
Unified Parkinson’s Disease Rating Scale or UPDRS
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: They will wear glasses for two weeks. At the time of receiving the intervention (TEBL), the participants will be asked to wear glasses that shine active bright light through a light source consisting of 2 blue-green light emitting diodes (Re-Timer, 500 nm peak wavelength) to each eye. with irradiance of each diode set at the high setting: 506 Lux lm/m² and 230 μW/cm²) every night, two hours before going to sleep for one hour. At the time of receiving the placebo treatment (control), the subjects will wear glasses with the same appearance, except that a modified light source with 2 dim red light-emitting diodes (Re-timer with 2 dim red light-emitting diodes, 625 nm peak wavelength with irradiance of each diode set at the low setting: 135 Lux lm/m², 143 μW/cm²) will shine the light to the eyes.
Category
Rehabilitation
2
Description
Control group: Participants receiving the placebo glasses will be asked to wear the red light glasses every night (two hours before bedtime) for one hour.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
مرکز دکتر موفقیان
Full name of responsible person
Javad Movafaghiyan
Street address
No 11, Khark St. Enghelab street.
City
Tehran
Province
Tehran
Postal code
9214450525
Phone
+98 21 6670 4122
Email
htdm.uswr@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohsen Shati
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2503
Email
info@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Laila Alibiglou
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8612 6135
Fax
Email
laila.alibiglou@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Laila Alibiglou
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8612 6135
Fax
Email
laila.alibiglou@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Laila Alibiglou
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8612 6135
Fax
Email
laila.alibiglou@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available