Nctid:
NCT00001252
Payload:
{"FullStudy"=>{"Rank"=>474082, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 06, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000009069", "ConditionMeshTerm"=>"Movement Disorders"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000002493", "ConditionAncestorTerm"=>"Central Nervous System Diseases"}, {"ConditionAncestorId"=>"D000009422", "ConditionAncestorTerm"=>"Nervous System Diseases"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M11719", "ConditionBrowseLeafName"=>"Movement Disorders", "ConditionBrowseLeafAsFound"=>"Movement Disorders", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M11774", "ConditionBrowseLeafName"=>"Muscle Rigidity", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M5432", "ConditionBrowseLeafName"=>"Central Nervous System Diseases", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Nervous System Diseases", "ConditionBrowseBranchAbbrev"=>"BC10"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Musculoskeletal Diseases", "ConditionBrowseBranchAbbrev"=>"BC05"}, {"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"StudyType"=>"Observational", "DesignInfo"=>{"DesignTimePerspectiveList"=>{"DesignTimePerspective"=>["Other"]}, "DesignObservationalModelList"=>{"DesignObservationalModel"=>["Case-Control"]}}, "EnrollmentInfo"=>{"EnrollmentType"=>"Anticipated", "EnrollmentCount"=>"7500"}}, "StatusModule"=>{"OverallStatus"=>"Recruiting", "StartDateStruct"=>{"StartDate"=>"March 13, 1995", "StartDateType"=>"Actual"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"June 6, 2023", "LastUpdateSubmitDate"=>"November 17, 2023", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"November 3, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"November 18, 2023", "LastUpdatePostDateType"=>"Actual"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 4, 1999", "StudyFirstPostDateType"=>"Estimate"}}, "OutcomesModule"=>{"PrimaryOutcomeList"=>{"PrimaryOutcome"=>[{"PrimaryOutcomeMeasure"=>"Gait Kinematics", "PrimaryOutcomeTimeFrame"=>"end of testing", "PrimaryOutcomeDescription"=>"Strength and spasticity testing both include torque or force measurements as the primary outcomes. Balance testing typically yields the amount, velocity and direction of sway in response to different conditions or perturbations."}]}}, "OversightModule"=>{"IsFDARegulatedDrug"=>"No", "IsFDARegulatedDevice"=>"No"}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Biomechanics", "Kinesiology", "Walking", "Natural History"]}, "ConditionList"=>{"Condition"=>["Movement Disorder"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"5336886", "ReferenceType"=>"background", "ReferenceCitation"=>"Murray MP. Gait as a total pattern of movement. Am J Phys Med. 1967 Feb;46(1):290-333. No abstract available."}, {"ReferencePMID"=>"9247066", "ReferenceType"=>"background", "ReferenceCitation"=>"Benvenuti F, Stanhope SJ, Thomas SL, Panzer VP, Hallett M. Flexibility of anticipatory postural adjustments revealed by self-paced and reaction-time arm movements. Brain Res. 1997 Jun 27;761(1):59-70. doi: 10.1016/s0006-8993(97)00260-6."}, {"ReferencePMID"=>"8257307", "ReferenceType"=>"background", "ReferenceCitation"=>"Hallett M, Lebiedowska MK, Thomas SL, Stanhope SJ, Denckla MB, Rumsey J. Locomotion of autistic adults. Arch Neurol. 1993 Dec;50(12):1304-8. doi: 10.1001/archneur.1993.00540120019007."}]}, "SeeAlsoLinkList"=>{"SeeAlsoLink"=>[{"SeeAlsoLinkURL"=>"https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_1990-CC-0168.html", "SeeAlsoLinkLabel"=>"NIH Clinical Center Detailed Web Page"}]}}, "DescriptionModule"=>{"BriefSummary"=>"This study will collect information on the different ways people control limb and body movements. This information will be used to develop a database on normal movements and adaptive movements of people who have diseases that affect the way they move. The database will serve as a tool to improve diagnosis and treatment of patients with movement-related problems.\n\nVolunteers of all ages who have normal movement patterns or who have developed different ways to perform movement tasks may be eligible for this study. A physician or physical therapist will screen candidates to determine their strength, flexibility and range of motion of joints.\n\nParticipants will be asked to perform movements such as walking, walking up or down stairs, standing quietly or reaching for an object or using treadmill. For the test, the arms and legs are wrapped with a soft, rubber-like material to which small plastic reflective balls are attached. A piece of firm material called a shell may be attached to the rubber sleeves or other areas of the body. Then the volunteer performs the specified task several times while special cameras record the movement. These cameras will record the positions of the reflective balls during movement and may show the person s face or body. Electrical activity in the muscles also may be measured, using small metal electrodes attached to the surface of the skin with an adhesive bandage.", "DetailedDescription"=>"The purpose of this study is to develop a database of normative and adaptive control strategies for human motion. Volunteers will serve as subjects after they complete a neuromusculoskeletal screening exam. Subjects will be asked to perform one or more tasks related to the execution of activities of daily living such as: walking on the ground, walking on a treadmill, quiet and perturbed standing, stair ascent and descent, turning and jumping, cycling, elliptical training, and isolated upper and lower extremity limb movements or trunk movements. The subjects movement patterns will be recorded using a three-dimensional motion tracking system. Motion data will be analyzed using a rigid body six degree-of-freedom approach when applicable. Temporal/spatial, kinematic, kinetic, and surface electromyographic variables will be collected and calculated. When only temporal-spatial parameters are of interest, an instrumented portable walkway system may be used.\n\nMany factors affect the ability to move. The ones we are mainly interested in investigating include muscle weakness, spasticity, and dynamic balance. To quantify strength or spasticity, a force transducer is needed such as a Biodex isokinetic dynamometer which is a standard rehabilitation assessment and training device, or a more simple handheld dynamometer can be used that the person presses against as force is recorded. For the spasticity tests, a person or a machine such as the Biodex moves a joint through an arc of motion (e.g. elbow, knee, or ankle) at a range of speeds from 5-240 degrees per second while resistance to motion is being recorded or graded subjectively. EMG and joint position may be collected simultaneously during the passive movements. The dynamic balance tests will be performed on a force plate or using a clinical balance testing device, the Equitest, by Neurcom. To determine if electrical stimulation (ES) improves limb movement, walking, and balance, a FDA-cleared device (LG-8TM FDA 510K 4 Channel TENS/EMS Unit, LGmedsupply.com) may be used in patients who have some gait dysfunction in their lower extremities. Only persons with central nervous system injuries who have an abnormal gait pattern will be given the opportunity to use this device. The device delivers individually programmed ES to aid in muscle function of the hip, knee or ankle.\n\nPatient groups will be identified clinically or statistically. Group means and standard deviations will then be computed. It is hoped the database developed may serve as a tool by which individual patient data may be compared in order to facilitate the diagnosis and optimize the treatment and clinical outcome of patients with movement related problems.\n\nAn over ground harness system may be used for some of the over ground or instrumented gait and balance assessments if there is concern that the patient is too weak or unbalanced and therefore may trip or fall during the activity, or to help facilitate more normal patterns by decreasing the load borne by the trunk and/or legs."}, "EligibilityModule"=>{"Gender"=>"All", "MinimumAge"=>"1 month", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "SamplingMethod"=>"Probability Sample", "StudyPopulation"=>"Normal/healthy volunteers and volunteers with impairments of the neuromusculoskeletal system. Subjects will be evenly distributed between males and females", "HealthyVolunteers"=>"Accepts Healthy Volunteers", "EligibilityCriteria"=>"Any volunteer of any age from birth to old age who is deemed medically fit to participate and is willing to provide their informed consent will be included in the study."}, "IdentificationModule"=>{"NCTId"=>"NCT00001252", "BriefTitle"=>"Human Movement Database", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"A Rigid Body Database on Human Movement", "OrgStudyIdInfo"=>{"OrgStudyId"=>"900168"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"90-CC-0168"}]}}, "ArmsInterventionsModule"=>{"ArmGroupList"=>{"ArmGroup"=>[{"ArmGroupLabel"=>"healthy volunteer", "ArmGroupDescription"=>"Normal/healthy volunteers"}, {"ArmGroupLabel"=>"Impaired volunteer", "ArmGroupDescription"=>"volunteers with impairments of the neuromusculoskeletal system."}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"20892", "LocationCity"=>"Bethesda", "LocationState"=>"Maryland", "LocationStatus"=>"Recruiting", "LocationCountry"=>"United States", "LocationFacility"=>"National Institutes of Health Clinical Center", "LocationContactList"=>{"LocationContact"=>[{"LocationContactName"=>"For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)", "LocationContactRole"=>"Contact", "LocationContactEMail"=>"ccopr@nih.gov", "LocationContactPhone"=>"800-411-1222", "LocationContactPhoneExt"=>"TTY dial 711"}]}}]}, "CentralContactList"=>{"CentralContact"=>[{"CentralContactName"=>"Mayra J Medrano", "CentralContactRole"=>"Contact", "CentralContactEMail"=>"mayra.medrano@nih.gov", "CentralContactPhone"=>"(301) 451-7529"}, {"CentralContactName"=>"Diane L Damiano, Ph.D.", "CentralContactRole"=>"Contact", "CentralContactEMail"=>"damianod@cc.nih.gov", "CentralContactPhone"=>"(301) 451-7544"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Diane L Damiano, Ph.D.", "OverallOfficialRole"=>"Principal Investigator", "OverallOfficialAffiliation"=>"National Institutes of Health Clinical Center (CC)"}]}}, "IPDSharingStatementModule"=>{"IPDSharing"=>"Undecided", "IPDSharingDescription"=>".Protocol is silent on IPD sharing."}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institutes of Health Clinical Center (CC)", "LeadSponsorClass"=>"NIH"}, "ResponsibleParty"=>{"ResponsiblePartyType"=>"Sponsor"}}}}}}
