HemiplegiaNCT07754773
Motus Nova Foot Device for Patients With Hemiplegia
A study testing Motus Nova Foot in people with Hemiplegia and Cerebral Palsy, run by MultiCare Health System Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 20 years
- Conditions the study is for
- Hemiplegia, Cerebral Palsy, Hemiplegic Cerebral Palsy
- What is being tested?
- Motus Nova Foot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mary Bridge Children's Therapy Research & Movement Lab
Puyallup, Washington, 98372
Brenna Brandsma, PT, DPT, PCS, 253-697-5268, babrandsma@multicare.org
Sean Brown, PhD, 253-697-5402, sean.brown@multicare.org
About this study
Official title: Evaluating Gait After Use of The 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.
- Conditions
- Hemiplegia, Cerebral Palsy, Hemiplegic Cerebral Palsy
- Being tested
- Motus Nova Foot
- Keywords
- Motus Nova Foot, Gait Analysis, Cerebral Palsy, Hemiplegia
- Medical subject headings
- Hemiplegia, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motus Nova FootDevice
Motus Nova Foot device used in home therapy to improve gait for individuals with hemiplegia.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Motus Nova Foot |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 4 months
Secondary outcomes (3)
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.
Measured: 4 months
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.
Measured: 4 months
Device adherence
Describe adherence using device-recorded usage data (mins/day) and explore association with outcomes.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MultiCare Health System Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brenna Brandsma, MultiCare Health System Research Institute
- Investigators
- Brenna Brandsma, PT, DPT, PCS, Principal investigator, MultiCare, Mary Bridge Children's Therapy Research & Movement Lab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754773
- Sponsor's protocol ID
- #2026/01/3
- Status last verified
- Aug 2026
- First submitted
- 5 Mar 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This is a small pilot study
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Gait After Use of The Motus Nova Foot Device for Patients With Hemiplegia
- ClinicalTrials.gov ID
- NCT07754773
- Acronym / sponsor ID
- #2026/01/3
- Conditions
- Hemiplegia, Cerebral Palsy, Hemiplegic Cerebral Palsy
- Keywords
- Motus Nova Foot, Gait Analysis, Cerebral Palsy, Hemiplegia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- MultiCare Health System Research InstituteUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Impact of Motus Nova Foot on Gait and Balance for Individuals with Hemiplegia | Experimental | Device: Motus Nova FootParticipants 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. |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motus Nova FootMotus Nova Foot device used in home therapy to improve gait for individuals with hemiplegia. | Device | Impact of Motus Nova Foot on Gait and Balance for Individuals with Hemiplegia |
Primary outcome
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).
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).
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).
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.
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.
3 secondary outcomes
Change across time points
Time frame: 4 months
Carryover/retention
Time frame: 4 months
Device adherence
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No. This is a small pilot study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brenna Brandsma, PT, DPT, PCS principal investigator
MultiCare, Mary Bridge Children's Therapy Research & Movement Lab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motus Nova Foot in people with Hemiplegia and Cerebral Palsy, run by MultiCare Health System Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brenna Brandsma, PT, DPT, PCS (12536975268, babrandsma@multicare.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heel strike (time frame: 4 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.