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:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-25 @ 2:27 AM
NCT ID:
NCT00708734
Eligibility Criteria:
Inclusion Criteria:
* Age 50 and older.
* Corrected vision not worse than 20/50.
* Ability to ambulate household distances without an assistive device - minimum functional status for ambulation as primary mode of mobility.
* Presence of knee OA based on clinical and radiological criteria.
Exclusion Criteria:
* Cognitive impairment with Mini Mental State Exam (MMSE) score \<24; Scores at or below 24 indicate cognitive impairments, limiting ability to participate in the group and/or remember instructions.
* Metastatic cancer, since this limits ability to fully participate in the group and/or complete the intervention due to limited life expectancy and changing functional status.
* Central or peripheral neurological dysfunction e.g. diagnosis of hemiparesis, cerebellar dysfunction, Parkinson's disease , peripheral neuropathy with or without foot drop, as determined by medical record review and physical exam; Severe Peripheral Vascular Disease with claudication or Spinal Stenosis with pseudoclaudication/chronic low back pain; These impairments would further impair gait and balance, and would jeopardize safety during the intervention and/or confound the effect of the intervention.
* Lower extremity amputations, or foot deformities; Mobility limitations due to altered lower extremity skin integrity/ulcer, where weight-bearing would be contraindicated (foot ulcers), since this would affect gait and balance measures.
* Use of medications known to impair balance, e.g. antipsychotics, benzodiazepines, anti-epileptics, etc. which would affect gait and balance measures.
* Severe arthritis limiting basic activities of daily living (ADL) and were offered or are pending joint replacement, since it is unlikely that any non-pharmacological intervention would be effective.
* Total knee replacement on one or both sides, since gait and balance changes due to total knee replacement would confound the effect of interventions.
* Current involvement in physical therapy, since it would confound results.
* Medically unstable upon exam, i.e. poorly controlled blood pressure or blood sugar, unstable coronary artery disease, since group participation may compromise medical status.
* Morbid obesity (BMI\>40) due to potential changes in gait variables (speed, cadence, stride length).
* Weight over 300 pounds (due to limitations of Neurocom force plate).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT00708734
Study Brief:
Protocol Section:
NCT00708734