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 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT01796860
Eligibility Criteria:
Inclusion Criteria:
* Individuals with a primary diagnosis of multiple sclerosis
* Individuals \>21 and \<60 years old
* Individuals who are able to maintain a walking velocity of 60 cm/sec for at least 2 minutes independently or with the use of a single tip assistive device.
* Current or past history of single or bilateral AFO use, including neuroprostheses
* Evidence of weakness in plantarflexors
Exclusion Criteria:
* The presence of co-morbidities (neuromuscular or musculoskeletal) that would negatively impact gait training
* Individuals with BMI with \>/= 35kg/m2
* Individuals with range of motion deficit in the ankle limiting passive range of motion to neutral dorsiflexion
* Individuals that will begin the use of Ampyra during the course of the study
* Individuals for whom the cost of an orthosis would represent a financial burden
* Individuals who are receiving concurrent physical therapy services elsewhere,
* Multiple Sclerosis Neuropsychological Questionnaire (MSNQ) of \>22
* Individuals for whom bilateral AFOs are indicated, but have different design
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
60 Years
Study:
NCT01796860
Study Brief:
Protocol Section:
NCT01796860