Background:
People with cerebral palsy, spina bifida, muscular dystrophy, or spinal cord injury often have muscle weakness and problems controlling how their legs move. This can affect how they walk. The NIH has designed a robotic device (exoskeleton) that can be worn on the legs while walking. The wearable robot offers a new form of gait training.
Objective:
To learn whether a robotic device worn on the legs can improve walking ability in those with a gait disorder.
Eligibility:
People aged 3 to 17 years with a gait disorder involving the knee joint.
Design:
Participants will be screened. They will have a physical exam. Their walking ability will be tested.
Participants will have markers taped on their body; they will walk while cameras record their movements. They will undergo other tests of their motor function and muscle strength.
The study will be split into three 12-week phases. During 1 phase, participants will continue with their standard therapy.
During another phase, participants will work with the exoskeleton in a lab setting. Their legs will be scanned to create an exoskeleton with a customized fit. The exoskeleton operates in different modes: in exercise mode, it applies force that makes it difficult to take steps; in assistance mode, it applies force meant to aid walking; in combination mode, it alternates between these two approaches.
During the third phase, participants may take the exoskeleton home. They will walk in the device at least 1 hour per day, 5 days per week, for 12 weeks.
Participants walking ability will be retested after each phase....
Provision of signed and dated separate informed consent and assent forms for screening purposes. Upon inclusion in the protocol, provision of signed and dated informed consent and assent forms to begin participation in the study will be necessary.
Stated willingness to comply with all study procedures and availability for the duration of the study, or alternatively, ability to do so based on parent report and physician observation during history and physical examination.
Age 3 to 17 years old.
Have a gait pathology involving the knee joint, from a diagnosis of cerebral palsy, muscular dystrophy, spina bifida, or incomplete spinal cord injury.
Any neurological, musculoskeletal or cardiorespiratory injury, health condition, or diagnosis other than cerebral palsy, muscular dystrophy, spina bifida, or incomplete spinal cord injury that would affect the ability to walk as directed with the robotic exoskeleton.
A history of uncontrolled seizure in the past year.
Pregnancy. A urine test will be performed for all participants who are able to become pregnant at the initial screening visit and in the case of a positive test, the participant will be excluded from participation. Further monitoring will rely on self-reporting of interruption in menstruation that would require re-testing for pregnancy at the next visit.
Any acute cardiopulmonary condition which limits exercise to less than 60 minutes per session or less than 5 days per week.
Crossover
EA-KAFO
DeviceThis study tests a single device that contains multiple potential configurations as outlined in Table 1 of the protocol. Each participant be evaluated in multiple configurations, minimally including the baseline configuration and the motor assist condition at the knee.
To evaluate the effectiveness of a longitudinal exoskeleton training program in the community, as opposed to a standard regimen of therapy of the same magnitude, at improving knee extension deficiency in children with CP, SB, iSCI or MD.
The primary endpoint will be knee extension range of motion. This will be assessed using knee angle at two positions in the gait cycle: knee angle at initial contact and peak knee angle during stance
To evaluate improvement in overground walking of children with CP, SB, iSCI or MD as a function of average gait speed while walking with the robotic exoskeleton
This outcome will be measured using peak and mean activation of knee extensor and knee flexor muscles during walking.
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