Motus Nova Foot Device for Patients With Hemiplegia

NCT07754773 | Not Yet Recruiting FDA Device

• 1 other identifier: #2026/01/3
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiplegia; Cerebral Palsy; Hemiplegic Cerebral Palsy

Keywords

Motus Nova Foot; Gait Analysis; Cerebral Palsy; Hemiplegia

Outcome Measures

Primary Outcomes (5)

• 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).

  4 months

• 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).

  4 months

• 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).

  4 months

• 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.

  4 months

• Balance performance

  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.

  4 months

Secondary Outcomes (3)

• Change across time points

  4 months

• Carryover/retention

  4 months

• Device adherence

  4 months

Study Arms (1)

Impact of Motus Nova Foot on Gait and Balance for Individuals with Hemiplegia

EXPERIMENTAL

Participants will complete a home-based intervention using the Motus Nova Foot device for approximately 8-10 weeks. The device provides robot-assisted ankle/foot movement and interactive computer-guided therapeutic activities designed to improve ankle range of motion, strength, motor control, and gait mechanics. Participants are instructed to use the device 20-40 minutes per day, 4-5 days per week. Activities include 3-5 guided tasks targeting dorsiflexion, plantarflexion, and functional ankle control, with the device automatically recording usage and duration. Families receive an initial in-lab device fitting and training session, and research staff provide weekly check-ins (virtual or in-person) for troubleshooting and adherence support. After the intervention phase, participants complete an 8-10-week no-treatment carryover period with no device use to assess retention of gains.

Device: Motus Nova Foot

Interventions

Motus Nova Foot DEVICE

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

Impact of Motus Nova Foot on Gait and Balance for Individuals with Hemiplegia

Eligibility Criteria

• Age: 12 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MultiCare Health System Research Institute: lead

Study Sites (1)

Mary Bridge Children's Therapy Research & Movement Lab

Puyallup, Washington, 98372, United States

Location

MeSH Terms

Conditions

Hemiplegia; Cerebral Palsy

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases

Study Officials

• Brenna Brandsma, PT, DPT, PCS

  MultiCare, Mary Bridge Children's Therapy Research & Movement Lab

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brenna Brandsma, PT, DPT, PCS

CONTACT

12536975268; babrandsma@multicare.org

Sean Brown, PhD

CONTACT

253-697-5402; sean.brown@multicare.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)