Motus Nova Foot Device for Patients With Hemiplegia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-20
SponsorMultiCare Health System Research Institute
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Motus Nova Foot
DeviceMotus Nova Foot device used in home therapy to improve gait for individuals with hemiplegia.
Treatment groups
5 Participants
are divided into 1 treatment groupGroup A: Impact of Motus Nova Foot on Gait and Balance for Individuals with HemiplegiaExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Heel strike
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).
Time frame
4 months2
Ankle dorsiflexion
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).
Time frame
4 months3
Gait symmetry
Gait symmetry / Limp - average angle in degrees of asymmetry or "limp" during walking on 10 meter pathway. Collected with 3D motion capture (analyzing kinematics).
Time frame
4 months4
sEMG activation
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.
Time frame
4 monthsSecondary outcomes
1
Change across time points
Describe change trajectories across baseline, midpoint, and final timepoints. Data collected via 3D motion capture, electromyography, force plates will be compared.
Time frame
4 months2
Carryover/retention
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.
Time frame
4 months3
Device adherence
Describe adherence using device-recorded usage data (mins/day) and explore association with outcomes.
Time frame
4 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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