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Robotic Ankle Assist Device

Phase 1

Cerebral Palsy | Unknown | Neurology |National Healthcare Corp.|Last Updated: Apr 4, 2025

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment31

FDA Designations

No designations recorded

Clinical trial landscape

Robotic Ankle Assist Device · 1 trial · 1 indication

Phase 1 1
NCT04516343Development of a Robotic Ankle Assist DeviceCerebral Palsy
COMPLETED31 Analytics
PHASE1COMPLETED
Development of a Robotic Ankle Assist Device
Cerebral PalsyUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in Preferred Walking Speed
baseline and post intervention at 6 minutes

How fast someone prefers to walk

Secondary Endpoints

Change in COT
baseline and post intervention
Change in 6MWT
6 minutes pre/post
Change in Gait Kinetics
6 minutes pre/post
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Therapist supervised assistance trainingEXPERIMENTALAssistance training with the RAAD under therapist supervision.
Therapist supervised resistance trainingEXPERIMENTALResistance training with the RAAD under therapist supervision.

Interventions

NameTypeDescription
Robotic Ankle Assist Device (RAAD)DEVICEThe RAAD (Robotic Ankle Assist Device) is an intelligent, powered ankle device designed to increase independence, mobility, and deliver gait training to children with movement disorders, such as CP
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Eligibility Criteria

Age Range8 Years to 21 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: Diagnosis of cerebral palsy. Any sex, race, ethnicity or socioeconomic status. GMFCS level I, II, or II. Ability to walk for at least 6 minutes (assisted or unassisted). Age between 8-18 years. Height/weight/BMI between the 5th - 95th percentile of children with CP. Able to und...

Countries:United States
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Frequently asked questions about Robotic Ankle Assist Device

What is Robotic Ankle Assist Device used for in Cerebral Palsy?

Robotic Ankle Assist Device is an investigational device being developed for use in Cerebral Palsy. It is currently in Phase 1 clinical development. The device is intended to assist ankle function in patients with this condition, though specific efficacy outcomes have not been reported.

Who makes Robotic Ankle Assist Device?

Robotic Ankle Assist Device is being developed by National Healthcare Corp. (ticker: NHC). The company is conducting clinical research on this device for the treatment of Cerebral Palsy.

What phase is Robotic Ankle Assist Device in?

Robotic Ankle Assist Device is in Phase 1 clinical development. It is an investigational device and has not been approved by regulatory authorities. One Phase 1 trial has been completed.

What clinical trials is Robotic Ankle Assist Device in?

Robotic Ankle Assist Device has one completed clinical trial, NCT04516343, titled 'Development of a Robotic Ankle Assist Device'. This Phase 1 study enrolled 31 participants with Cerebral Palsy in the United States, with a minimum age of 8 years.

Is Robotic Ankle Assist Device the same as any other device?

No alternative names for Robotic Ankle Assist Device have been reported. It is identified by this name in clinical trial records and by its developer, National Healthcare Corp.