Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-24 @ 2:56 PM
NCT ID:
NCT02380859
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of idiopathic Parkinson's Disease
* Referral for gait training
* Aged 40 -85
* If the subject is taking CNS-acting medications (benzodiazepines, hypnotics, antidepressants), regimen must be stable for 30 days prior to baseline visit
* Subjects with Stage 11.5 - Stage IV (Hoehn and Yahr scale) where stage II.5 is bilateral involvement with axial involvements, but without balance difficulty, to Stage IV where one has severe disability but is still able to walk or stand unassisted
* Subjects with any of the following abnormal scores (greater than 0) in the MDS-UPDRS Part III; a) Part III.10 Gait; b) Part III.11 Freezing of gait c) Part III.12 Postural Stability; subjects with Timed up and go test \>12 seconds
* Right handed participants are preferred due to the cortical lateralization of functions related to sensorimotor adaptation and postural control.
* However, we will recruit left-handed participants if there are insufficient right-handed volunteers.
Exclusion Criteria:
* Subjects with a known psychiatric comorbidity that in the investigator's opinion would compromise participation in the study; subjects with a neurologic diagnosis, other than Parkinson's disease that can cause imbalance and gait impairment (e.g., multiple sclerosis, stroke, subdural hematoma, peripheral neuropathy)
* Injury or impairment to the right arm (other than that which is due to Parkinson's disease) that would affect pointing movements; subjects with normal score on UPDRS part III
* Classified as legally blind or lacking sufficient visual acuity to view the target and pointing hand during prism adaptation
* Lacking sufficient understanding of verbal and written information in English to complete any of the consent screening forms.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
85 Years
Study:
NCT02380859
Study Brief:
Protocol Section:
NCT02380859