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 @ 3:36 PM
Ignite Modification Date:
2025-12-24 @ 3:36 PM
NCT ID:
NCT06385392
Eligibility Criteria:
Inclusion Criteria:
* Ability to provide and provision of signed and dated informed consent form.
* Age 45 or older
* Diagnosis of idiopathic PD, as determined by a movement disorders neurologist in accordance with the PD Society Brain Bank diagnostic criteria.
* Evidence of presence of freezing gait as a symptom. Determined from combination of clinical examination (observation of freezing) and New Freezing of Gait Questionnaire (NFOG).
* Able to complete a 2-minute walk test at the pre-treatment visit.
* Currently on a stable prescription medication regimen for PD and willing to adhere to the regimen during the study.
* Ability to don and doff the insole and haptic module independently or have daily assistance during the study intervention.
Exclusion Criteria:
* Non-English speaking
* History of musculoskeletal disorders that significantly affect movement of lower limbs as determined at the time of enrollment.
* Other significant neurological disorders that may affect participation or performance in the study.
* Neuropathy at the ankle assessed at the pre-treatment visit using the haptic module.
* Hallucinations
* Non-ambulatory
* Legally Blind
* Symptomatic hypotension
* Any condition which would limit sensation in the legs or requires use of wraps, bandages or other items which may limit sensation in the legs (e.g., lymphedema) that would interfere with the performance of the haptic device, in the opinion of the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
80 Years
Study:
NCT06385392
Study Brief:
Protocol Section:
NCT06385392