Clinical trial: Gait Adaptations to Passive Dynamic Ankle-Foot Orthosis Use (NCT00115401)

Eligibility criteria:
-  ELIGIBILITY CRITERIA:

        This study will include healthy males and females who are over four years of age. The study
        will involve healthy volunteers having normal lower extremity strength profiles and healthy
        volunteers with impaired ankle joint plantarflexion strength. For this project, the term
        healthy is defined as a lack of systemic disease that alters ability of subjects to
        participate in activities of their choice. In addition, healthy means no current pathology
        where there is any possibility of damage to muscle, ligament, or cartilage in the lower
        extremity. An attempt will be made to obtain an equal distribution between males and
        females. In addition, participation of minorities will be strongly encouraged through the
        use of existing outreach programs.

        INCLUSION CRITERIA:

        Subjects must be capable of repeatedly walking 15m independently and unsupervised. They
        must be co-operative and able to follow commands and have adequate natural step and stride
        lengths to step on three force plates in series. Subjects must have a combined lower limb
        size (shank and foot) that results in a PD-AFO size within the prototyping capacity (50 cm)
        of the selective laser sintering machine. To participate in the impaired study, subjects
        must have a manual muscle strength score for plantarflexion strength that is less than or
        equal to three out of a five point scale.

        EXCLUSION CRITERIA:

        Subjects with an unsafe or highly variable gait pattern upon visual observation will be
        excluded. Subjects who are unable to repeatedly walk through the data collection volume
        without the use of assistive devices will be excluded. In addition, subjects with pain
        related to walking or impaired skin sensation (touch and pressure) will be excluded.
        Subjects with lower extremity muscle spasticity of 3 or greater on the Ashworth Scale will
        be excluded. Subjects with a history of injury, surgery, or disease affecting the function
        of the lower extremity will be excluded from the normal study. Subjects will be excluded
        from participation in the normal study if muscle strength and joint range of motion
        measures are outside normal limits.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 5 Years old.


Patient description (medical language): An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD.

Patient description (patient's own words): I brought my  8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy.

Does the patient match the trial criteria? Entailment