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IRCT20221014056170N1 IRCT 2023-01-09 Iran University of Medical Sciences The effect of circadian rhythms modulation for gait initiation in people with Parkinson’s disease CPD The effect of circadian rhythms modulation on anticipatory postural adjustments for gait initiation in people with Parkinson’s disease 2023-01-21 anticipated 16 Complete https://irct.ir/trial/66304 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, 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, 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 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. N/A Parkinson disease. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Laila Alibiglou
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, IRAN
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 8612 6135 laila.alibiglou@gmail.com Iran University of Medical Sciences scientific Laila Alibiglou
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, IRAN
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 8612 6135 laila.alibiglou@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) 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. 40 years 75 years Both 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) G20 Parkinson's disease Rehabilitation Placebo 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. 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. 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. 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. 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. 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. Iran University of Medical Sciences Approved 2022-12-14 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemat highway Tehran Tehran Iran (Islamic Republic of)