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 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT02887703
Eligibility Criteria:
Inclusion Criteria:
* Report to be in good general health
* Are able to read and comprehend English
* Have been diagnosed with either an inherited or sporadic degenerative cerebellar or sensory ataxia
* Are able to stand for at least 30 seconds with no support
* Must be willing and able to comply with study schedule
* Must have wireless internet (WiFi) enabled in their home
* Must be able to perform the home based exercises safely (as assessed by clinical research staff)
Exclusion Criteria:
* Are pregnant or believe subject might be pregnant
* Have been diagnosed with arthritis or other musculoskeletal disorder affecting joints, muscles, ligaments and/or nerves that affects the way subject moves
* Have a history of fainting
* Have a severe vision or hearing impairment that is not corrected by glasses or hearing aids
* Have sustained a fall in the last six months that resulted in hospitalization or serious injury
* Have corrected vision worse than 20/70 (considered threshold for moderate visual impairment)
* Are unable to feel the vibrotactile feedback on their torso through the standard t-shirt provided by the study team
* Have ankle dorsi-flexor/plantar-flexor weakness as demonstrated \< 4/5 on manual muscle test
* Have limited ankle range of motion demonstrated by inability to dorsiflex to neutral with the knee extended
* Report lower extremity fracture/sprain in the past six months or more than one lower extremity total joint replacement
* Are medically unstable (e.g. chest pain upon exertion, dyspnea, infection)
* Have a history of any other neurological disease besides ataxia that might affect balance (e.g. cerebral vascular accident, Parkinson's disease, MS, ataxia)
* Have a body mass index (BMI) over 30 kg/m2, computed from subject height and weight
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02887703
Study Brief:
Protocol Section:
NCT02887703