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NCT07754773
Motus Nova Foot Device for Patients With Hemiplegia
Conditions: Hemiplegia, Cerebral Palsy, Hemiplegic Cerebral Palsy
Sex: All
Ages: 12 Years – 20 Years
Healthy volunteers: No
Phase: NA
Enrollment: 5
Sponsor: MultiCare Health System Research Institute
Location: Mary Bridge Children's Therapy Research & Movement Lab Puyallup Washington
Summary
Individuals with hemiplegia commonly demonstrate gait deviations such as difficulties with heel strike at initial contact, foot drop in swing, asymmetrical limb loading, muscle activation, and balance impairments. This study evaluates whether a therapeutic device (Motus Nova Foot; FDA approved) used in the home setting can increase heel strike, decrease limp, improve foot clearance in swing phase, improve quality of active muscle contraction of the affected limb, and improve balance. The Motus Nova Foot moves the ankle/foot and uses guided computer/video activities to encourage active participation while automatically recording device use and duration.
Eligibility Criteria
Inclusion Criteria:
* Age 12-20 years.
* Diagnosis consistent with hemiplegia and gait/balance impairments involving ankle/foot control (e.g., reduced heel strike).
* Able to ambulate and safely participate in laboratory walking and balance testing.
* Able to follow instructions and use the Motus Nova Foot system at home with family support as needed.
* Willingness to refrain from standard clinic-based PT during the study period.
Exclusion Criteria:
* Skin integrity issues or hypersensitivity preventing safe use of straps/pads.
* Medical/orthopedic conditions making walking or balance testing unsafe (e.g., unstable seizures, recent surgery, acute injury).
* Inability to safely use the device as determined during fitting/training.
* Planned participation in standard clinic-based PT during the study period.
* Electrical stimulation device to lower extremity within 6 months of study start, or planned use of electrical stimulation to lower extremity during study period.
* Heart conditions that prevent physical activity.
* Pregnancy.
Source: ClinicalTrials.gov (NCT07754773). StuddyBuddy aggregates publicly available trial information.