Home foot device to help walking in young people with hemiplegia

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for young people aged 12-20 years with hemiplegia (weakness on one side of the body) who have walking or balance problems involving ankle and foot control. They use the Motus Nova Foot device at home.

Age

12 to 20 years

Sex

All sexes

Disease stage

Hemiplegia with walking or balance problems involving ankle/foot control, for example reduced heel strike. Must be able to walk and safely take part in walking and balance tests.

Earlier treatment

No electrical stimulation device on the leg within 6 months of study start. Must agree to stop standard clinic-based physical therapy (PT) during the study.

Main reasons for not taking part

• Skin problems or sensitivity that prevent safe use of straps or pads
• Medical or bone/joint conditions that make walking or balance testing unsafe, such as unstable seizures, recent surgery or acute injury
• Heart conditions that prevent physical activity
• Planned clinic-based PT or electrical stimulation to the leg during the study
• Pregnancy

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 12 and 20 years old?YesNo

What the trial wants to find out

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.

The group in the trial

• Impact of Motus Nova Foot on Gait and Balance for Individuals with HemiplegiaTreatment being tested

  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.

  Treatment: Motus Nova Foot