ClinicalTrials.gg
Not yet recruitingNCT07754773Updated Aug 10, 2026

Motus Nova Foot Device for Patients With Hemiplegia

An interventional study of Motus Nova Foot in Hemiplegia, Cerebral Palsy and Hemiplegic Cerebral Palsy, sponsored by MultiCare Health System Research Institute. Not yet recruiting at 1 site in United States. Open to participants aged 12 Years to 20 Years. Per ClinicalTrials.gov, last updated 2026-08-10.

Sponsored by MultiCare Health System Research Institute · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
12 Years to 20 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hemiplegia
  • Cerebral Palsy
  • Hemiplegic Cerebral Palsy

Keywords

  • Motus Nova Foot
  • Gait Analysis
  • Cerebral Palsy
  • Hemiplegia
03

In context

Hemiplegia

446 studies on the registry are indexed under Hemiplegia; 90 are open to participants now.

This study's planned enrollment of 5 is below the median of 34 across 370 interventional studies indexed under Hemiplegia.

Browse Hemiplegia studies →

Lead sponsor

MultiCare Health System Research Institute is the lead sponsor of 14 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 20 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Skin integrity issues or 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (estimated)

Study arms

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

    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

  • DeviceMotus Nova Foot

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

06

What researchers measure

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 months

  2. 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 months

  3. 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 months

  4. 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 months

  5. 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.

    Time frame: 4 months

Secondary 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 months

  2. 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 months

  3. Device adherence

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

    Time frame: 4 months

07

Study locations

1 site
  • Mary Bridge Children's Therapy Research & Movement Lab
    Puyallup, Washington 98372, United States
08

References and documents

Individual participant data

Plan to share: No — This is a small pilot study

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Dec 2027, 15 months later.

Of 223 non-industry interventional studies with no phase under Hemiplegia, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 27. This study's planned 15 months is above that.

Counting every sponsor, half of 228 studies reached it within 12 months; a quarter within 5 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 5, 2026
First posted
Aug 10, 2026
StartEst.
Sep 2026
Primary completionEst.
Dec 2027
CompletionEst.
Dec 2027
Last update
Aug 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07754773
Lead sponsor
MultiCare Health System Research Institute
Responsible party
Brenna Brandsma (Physical Therapist, MultiCare Health System Research Institute) — Principal investigator
First posted
Aug 10, 2026
Start date
Sep 2026 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Aug 10, 2026

Study contacts

Brenna Brandsma, PT, DPT, PCS
Contact
babrandsma@multicare.org
12536975268
Sean Brown, PhD
Contact
sean.brown@multicare.org
253-697-5402
Brenna Brandsma, PT, DPT, PCS
principal investigator · MultiCare, Mary Bridge Children's Therapy Research & Movement Lab

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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