Cerebral Palsy, Hemiplegia, Hemiplegic Cerebral Palsy
Conditions
Keywords
Motus Nova Foot, Gait Analysis, Cerebral Palsy, Hemiplegia
Brief 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.
Interventions
DEVICEMotus Nova Foot
Motus Nova Foot device used in home therapy to improve gait for individuals with hemiplegia.
Sponsors
MultiCare Health System Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 20 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heel strike | 4 months | Heel strike: number of heel strikes on 10 meter walkway at initial contact during walking - whether the participant makes heel-first contact at the beginning of stance. Collected with 3D motion capture (analyzing kinematics). |
| Ankle dorsiflexion | 4 months | Ankle dorsiflexion during swing phase - average angle in degrees of dorsiflexion achieved while the foot is off the ground during gait on 10 meter walkway. Collected with 3D motion capture (analyzing kinematics). |
| Gait symmetry | 4 months | Gait symmetry / Limp - average angle in degrees of asymmetry or "limp" during walking on 10 meter pathway. Collected with 3D motion capture (analyzing kinematics). |
| sEMG activation | 4 months | Lower-extremity muscle activation patterns during gait (sEMG) on 10 m walkway - timing and amplitude characteristics of muscle activity will be measured in mV. Collected with kinesiologic surface electromyograph (sEMG) during 3D motion capture. |
| Balance performance | 4 months | Balance performance - double- and single-leg stance measures (eyes open/closed and weaker vs. stronger limb), measured in distance of center of pressure under foot (mm). Collected via embedded force plates. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change across time points | 4 months | Describe change trajectories across baseline, midpoint, and final timepoints. Data collected via 3D motion capture, electromyography, force plates will be compared. |
| Carryover/retention | 4 months | Explore carryover/retention of gains on primary outcome measures, after stopping device use. Data collected via 3D motion capture, electromyography, force plates will be compared. |
| Device adherence | 4 months | Describe adherence using device-recorded usage data (mins/day) and explore association with outcomes. |
Countries
United States
Contacts
CONTACTBrenna Brandsma, PT, DPT, PCS
CONTACTSean Brown, PhD
PRINCIPAL_INVESTIGATORBrenna Brandsma, PT, DPT, PCS
MultiCare, Mary Bridge Children's Therapy Research & Movement Lab
Outcome results
None listed