grant
A phase I/II trial evaluating long-term use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to improve gait in children with movement disorders
Organization CLINICAL CENTERLocation UNITED STATES
NIHUS FederalResearch GrantFY20250-11 years old21+ years oldAdultAdult HumanArticular Range of MotionBiomechanicsCategoriesCerebral PalsyChildChild YouthChildhoodChildren (0-21)ClassificationClinicClinicalCommunitiesComputersCross-Over StudiesCross-Over TrialsCrossing OverCrossover StudiesCrossover TrialsDNA crossoverDevicesDiagnosisDisability AssessmentDisability DeterminationDisability EvaluationDiseaseDisorderDyskinesia SyndromesEducation for InterventionEducational InterventionEffectivenessEffectiveness of InterventionsElectronicsEnrollmentEquipment and supply inventoriesExtensorExtremitiesFlexorFreedomGaitGait speedGenetic Crossing OverGoalsHomeHourInstruction InterventionInterventionInventoryIsometric ExerciseIsometricsJoint Range of MotionKneeKnee jointLengthLibertyLimb structureLimbsMeasuresMedical RehabilitationMonitorMotorMovement Disorder SyndromesMovement DisordersMuscleMuscle SpasticityMuscle TissueMuscle-Setting ExerciseMuscular DystrophiesMyodystrophicaMyodystrophyNational Institutes of HealthNeuro rehabilitationNeuromuscular DiseasesNeurorehabilitationNon-TrunkOrthosisOrthotic DevicesOut-patientsOutcome AssessmentOutpatientsParticipantPatientsPhasePhase 1/2 trialPhase I/II TrialPhysiatricsPhysiatryPhysical MedicinePostureProceduresProtocolProtocols documentationRandomizedRehabilitationRehabilitation MedicineRehabilitation therapyResearch DesignRoboticsSafetySchistorrhachisSiteSpina BifidaSpinal Cord TraumaSpinal DysraphiaSpinal DysraphismSpinal TraumaSpinal cord injuredSpinal cord injuryStatic ExerciseStructureStudy TypeSystemSystematicsTarget PopulationsTechnologyTestingTimeTorqueTrainingTraining InterventionTraumatic MyelopathyUnited States National Institutes of HealthVisitWalkingWithdrawaladulthoodassess effectivenessbiomechanicalcleft spineclinical centercrossover recombinationcrouch gaitdesigndesigningdetermine effectivenessdosageeffectiveness assessmenteffectiveness evaluationelectronicelectronic deviceenrollevaluate effectivenessexamine effectivenessexoskeletalexoskeletonfunctional improvementgait recoverygait rehabgait rehabilitationgait retraininggait traininggenomic crossoverhomeshydrocele spinalisimprove functionimprovedimproved functional outcomesinstructional interventioninter-homolog crossoverkidslab experiencelab traininglaboratory experiencelaboratory trainingmeiotic crossovermuscle dystrophymuscle strengthmuscle strengtheningmuscularmyoneural disorderneurological rehabneurological rehabilitationneuromuscular activityneuromuscular degenerative disorderneuromuscular disorderneurorehabneurorehabilitativenon-sister chromatid exchangenonsister chromatid exchangenovelorthoticspatient populationpediatricpost interventionprimary end pointprimary endpointrachischisis posteriorrandomisationrandomizationrandomly assignedrange of motionrecruitrectus femorisrehab therapyrehabilitativerehabilitative therapyrobot exoskeletonrobotic exoskeletonsafety and feasibilitysensorstrength trainingstudy designvastus lateraliswearable roboticsyoungster
Description preview
This is a single site outpatient study at the National Institutes of Health Clinical Center, Rehabilitation Medicine Department, Neurorehabilitation and Biomechanics Section. This is a study of a novel device. It is a pivotal study, analogous to phase 1, designed to assess both safety and effectiveness of the intervention.
This is a study of…
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