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NCT Number: NCT07754773

Motus Nova Foot Device for Patients With Hemiplegia

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.

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Key information

Conditions

Hemiplegia Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Hemiplegic Cerebral Palsy Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Motus Nova Foot

Device

Motus Nova Foot device used in home therapy to improve gait for individuals with hemiplegia.

Primary outcomes

  1. Heel strike

    Time frame: 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).

  2. Ankle dorsiflexion

    Time frame: 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).

  3. Gait symmetry

    Time frame: 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).

  4. sEMG activation

    Time frame: 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.

  5. Balance performance

    Time frame: 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 outcomes

  1. Change across time points

    Time frame: 4 months

    Describe change trajectories across baseline, midpoint, and final timepoints. Data collected via 3D motion capture, electromyography, force plates will be compared.

  2. Carryover/retention

    Time frame: 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.

  3. Device adherence

    Time frame: 4 months

    Describe adherence using device-recorded usage data (mins/day) and explore association with outcomes.

Study contacts

Contact information is provided by the study sponsor or research team.

Brenna Brandsma, PT, DPT, PCS

CONTACT

[email protected]

12536975268

Sean Brown, PhD

CONTACT

[email protected]

253-697-5402

Sponsors and collaborators

Lead sponsor

MultiCare Health System Research Institute

Other

Registry information

Official study title

Evaluating Gait After Use of The Motus Nova Foot Device for Patients With Hemiplegia

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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