Pisa Syndrome Clinical Trial
Official title:
Randomized Double-blind Study on the Effect of Orthoptic Rehabilitation in Pisa Syndrome Associated With Parkinson's Disease
Non-pharmacological interventional pilot study on the effect of prismatic glasses for the
improvement of Pisa syndrome in Parkinson's disease.
The study involves 40 patients, of whom 20 receive active treatment and 20 slow placebo. At
the end of the study, all patients receive corrective lenses in compassionate use if the
study yields positive results.
In previous cases of patients with Parkinson's disease and Pisa Syndrome, the investigators
found a slight improvement in the dystonia of the trunk after the application of prismatic
lenses.
The current study provides the involvement of 40 patients with Parkinson's disease, of which
twenty treated with permanent prismatic optical correction, and twenty treated with neutral
optical correction or with the only optical correction of the refractive basic defects
(placebo).
The protocol provides the collection of these data:
- Personal data (date of birth, sex, marital status, profession)
- General history (weight, height, non-neurological and neurological concomitant
pathologies, medical conditions that may be associated or predisposing patients to PS,
non-antiparkinsonian therapy in progress)
- Specific history for PD (year from the first diagnosis of PD, year of appearance of the
first motor symptoms of PD, type and distribution of motor symptoms at the onset)
- Pharmacological history of PD (year of initiation of the first treatment for PD, which
drugs (s), antiparkinsonian therapy in progress)
- Neurological Evaluation in ON: UPDRS I, II, III and IV (III: also items-20-26 right and
left side), Hoehn-Yahr stage;
- Specific history for PS;
- Detection of some information about the patients' perception of having the torso tilted
sideways, direction of inclination, how long it is present, how long it is manifested,
conditions in which this inclination is present (standing, sitting, etc.) )
- Presence of low back pain and pain intensity measured with the Visual Analogue Scale
(VAS).
Clinical and kinematic evaluation of PS:
- The amount of dystonia measured in degrees with the patient positioned against the wall
against a dedicated protractor. This measurement is photographed.
- Static and dynamic kinematic evaluation (gait analysis) according to the following
protocol: 30 seconds stationary in orthostatic position, shoulders to the cameras, about
5 steps forward, stationary in orthostatic position while fixing visual stimulation
points placed on the wall, 30 second stationary in an orthostatic position after having
covered a section of the corridor in front of the kinematic evaluation room.
Orthoptic evaluation:
complete orthoptic evaluation and prescription of personalized prismatic lenses, randomizing
the patient on active or slow-moving placebo lenses with respect to the other experimenters
and the patient.
Flowchart of visits:
Screening: the neurologist selects the patient according to the eligibility criteria
indicated above and verifies the patient's willingness to participate.
Randomization: the patient undergoes clinical and kinematics evaluation of the PS, orthoptic
examination and randomization on active lenses and placebo.
Study times:
T0: randomization and prescription of lenses T1: check after 1 month from the use of lenses
Patients are recruited at the Parkinson's Center of the IRCCS Neuromed.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04620863 -
TRANSCRANIAL DIRECT CURRENT STIMULATION (t-DCS) AS ADD-ON TO NEUROREHABILITATION OF PISA SYNDROME IN PARKINSON DISEASE
|
N/A |