grant

Leg Stretching Using a Controllable Wearable Exoskeleton on Demand for People with Spasticity

Organization SYRACUSE VA MEDICAL CENTERLocation SYRACUSE, UNITED STATESPosted 1 Jan 2024Deadline 31 Dec 2026
VANIHUS FederalResearch GrantFY2025Aching musclesActivities of Daily LivingActivities of everyday lifeAddressAdverse effectsAlgorithmsAnkleApoplexyArticular Range of MotionAssistive TechnologyBed SoresBedsBedsoreBotoxBrain TraumaBrain Vascular AccidentBurden on their caregiversCOVID-19CV-19Care GiversCaregiver BurdenCaregiversCerebral StrokeCerebrovascular ApoplexyCerebrovascular StrokeChronicClient satisfactionClinicClinicalContractureCoronavirus Infectious Disease 2019CustomDataDermal injuryDevelopmentDevicesDiseaseDisorderDorsal PositionDoseDrowsinessDrugsDyskinesia SyndromesEffectivenessEquilibriumExerciseExtremitiesFamilyFamily NursingFamily memberFamily-Centered NursingFeasibility StudiesFeedbackFutureGoalsHealthHip JointHomeHospitalsHumanHyperkinesiaHyperkinesisHyperkinetic MovementsIndividualInjuryJoint Range of MotionJointsKneeKnee jointLegLimb structureLimbsLong-Term EffectsManipulation TherapyManipulative TherapiesManualsMeasuresMedicationModalityModern ManMotor CellMotor NeuronsMovement Disorder SyndromesMovement DisordersMuscleMuscle Cell ContractionMuscle ContractionMuscle SpasmMuscle TissueMuscle TonusMuscle WeaknessMuscle discomfortMuscle painMuscle pain/fibrositisMuscle sorenesssMuscular ContractionMuscular SpasmMuscular WeaknessMyalgiaMyalgicMyodyniaMyoneuralgiaMyosalgiaNon-TrunkNursesOralPainPainfulParticipantPatient SatisfactionPatientsPerformancePersonsPharmaceutical PreparationsPlayPositionPositioning AttributePosturePredispositionPressure SorePressure UlcerQOLQOL improvementQuality of lifeQuestionnairesRegio tarsalisResearchRoleSafetySedation procedureSelf-Help DevicesSkeletal MuscleSkin injurySleepSomnolenceSpasmSpinal Cord TraumaSpinal TraumaSpinal cord injuredSpinal cord injuryStretchingStrokeSupinationSupine PositionSusceptibilitySystemTechniquesTechnologyTestingTimeTraumatic Brain InjuryTraumatic MyelopathyVeteransVisitVoluntary MuscleWalkingassisted deviceassistive devicebalancebalance functionbarriers to implementationbrain attackburden in caregiversburden of their caregiversburden on caregiverscerebral vascular accidentcerebrovascular accidentclinical carecoronavirus disease 2019coronavirus disease-19coronavirus infectious disease-19customscutaneous injurydaily living functiondaily living functionalitydecubitus ulcerdesigndesigningdevelopmentaldrug/agentepidermal injuryexoskeletalexoskeletonexperiencefallsfootfunctional abilityfunctional capacityfunctional electrical stimulationfunctional electrostimulationhomesimplementation barriersimplementation challengesimprovedimprovements in QOLimprovements in quality of lifeinjuriesinjuries to skinjoint stiffnesslight weightlightweightmanual therapymotoneuronmotor neuron injurymotorneuron injurymuscle tonemuscularneurosurgerynovelnursepain reductionportabilitypressure injuryquality of life improvementrange of motionreduce painrehab strategyrehabilitation strategysatisfactionsedationside effectsleepinesssocial rolespasticitystrokedstrokessurgery risksurgical risktooltraumatic brain damagevibrationvolunteerwearablewearable devicewearable electronicswearable systemwearable technologywearable toolwearables
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Full Description

Spasticity is a debilitating condition in people with upper motor neuron disorders that interferes
with an individual’s activities of daily living and sleep. Spasticity can lead to loss of body control

and balance resulting in falls, pressure injury of the skin, contractures, and pain. Spasticity hinders

the ability to functionally use voluntary muscle contraction; thus, limiting body transfers,

ambulation, and exercise. Despite the negative impact of spasticity in people with spinal cord

injury (SCI), the available tools to manage spasticity and overcome functional deficits are limited.

Oral medications are typically prescribed at the start of treatment due to its ease of administration;

however, they may induce significant side effects including drowsiness and muscle weakness,

and their effectiveness is sensitive to dosing fluctuations. Neurosurgery can treat severe

spasticity, but it carries surgical risks, and the long-term benefits vary across individuals.

Manual therapy and leg stretching are primary treatments for a large subset of people with

spasticity, which is usually performed by caregivers and nurses with relatively low adverse effects.

Manual stretching can provide relief from muscle spasms, decrease joint stiffness, normalize

muscle tone, reduce pain, and improve range of motion. However, providing on-demand, reliable

manual limb stretching is caregiver intensive and imposes a heavy burden on nurses in hospitals

and caregivers at veterans’ homes. COVID-19 has exacerbated difficulties in receiving manual

stretching to manage spasticity by limiting physical assistance in veterans with SCI due to family

visit restrictions and staffing shortages. Moreover, existing devices used to mitigate spasticity

such as passive stretchers, casts and night splinters do not fully conform to the user's body and

are typically bulky and lack versatility to customize the forces applied to the user. People wearing

them may feel discomfort, weakness, or pain, and even experience pressure sores.

Our long-term research goal is to develop novel, non-invasive rehabilitation strategies

addressing the debilitating effects of spasticity, which can play an integral role in improving quality

of life and independence in persons with upper motor neuron injury. This feasibility study will

establish preliminary evidence for the development of a novel wearable, portable leg exoskeleton

capable of providing leg stretching - similar to the manual stretching provided by caregivers. The

objectives in this project are to 1) integrate a wearable exoskeleton and its closed-loop control

algorithm to provide strategic joint forces to assist dynamic leg stretching; and 2) evaluate the

stretching approach in 10 veterans with spasticity to establish safety, acceptability, ease of use,

and user satisfaction. Our central hypothesis is that the intelligent velocity control of the wearable

device can apply safe forces about the hip and knee joints to yield safe, automated stretching as

needed in veterans with spasticity. The control algorithm enables leg stretching while veterans lie

on a bed (supine position with their knee extended) and sit down (with their knee flexed) with

customized stretching rates to account for differences in range of motion across participants.

Questionnaires are used to collect veteran’s and clinician’s feedback on the device performance.

This study contributes to advancing non-invasive, non-pharmacological tools to manage

spasticity by establishing the feasibility of the wearable stretching device in veterans with SCI.

The project can lead to a customized, on-demand tool for the clinic and home, which can alleviate

the burden on caregivers, aid quantifying the long-term effects of stretching using clinical and

functional measures, and facilitate the integration of the device with other treatment modalities.

Grant Number: 5I21RX004652-02
NIH Institute/Center: VA

Principal Investigator: Steven Brose

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