- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00001252
Databáze lidského pohybu
Databáze tuhého těla o lidském pohybu
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.
Volunteers from one month old to old age 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.
Participants 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.
Přehled studie
Postavení
Podmínky
Detailní popis
STUDY DESCRIPTION:
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, 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.
OBJECTIVES:
Primary objectives:
To develop a database of normative and adapted movement strategies for human movement. The variables calculated from the established database will be presented as mean time histories to serve as standards by which individual patient and group motion data may be compared.
ENDPOINTS:
Primary Endpoint:
The primary endpoint here is to accumulate a large database of participants with and without different neuromuscular disorders that includes multiple measures of physical function and performance, so we can begin to investigate the mechanisms underlying various disorders on either a group or individual basis.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Mayra J Medrano
- Telefonní číslo: (301) 451-7529
- E-mail: mayra.medrano@nih.gov
Studijní záloha kontaktů
- Jméno: Katharine E Alter, M.D.
- Telefonní číslo: (301) 496-4733
- E-mail: kalter@cc.nih.gov
Studijní místa
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Maryland
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Bethesda, Maryland, Spojené státy, 20892
- Nábor
- National Institutes of Health Clinical Center
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Kontakt:
- For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
- Telefonní číslo: TTY dial 711 800-411-1222
- E-mail: ccopr@nih.gov
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Normal/healthy volunteers and volunteers with impairments of the neuromusculoskeletal system. Subjects will be evenly distributed between males and females
Popis
- INCLUSION CRITERIA:
Individuals with neuromuscular disorders and Healthy Volunteers in order to be eligible to participate in this study, must meet all of the following criteria:
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Children; One month old to 17 years of age
--In the case of infants and very young children, they need to be able to imitate or perform an action on cue (e.g., reach out for a toy that is presented or take steps if placed on a treadmill) based on the parent report if the subject is a child and physician observation during history and physical examination.
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Adults; 18 years 99 years
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In good general health as evidenced by medical history or diagnosed with impairment of neuromusculoskeletal system
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Stated willingness to comply with all study procedures and availability for the duration of the study
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Provision of signed and dated informed consent form
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For those participants older than 5 years of age who have an abnormal gait pattern when walking as a result of a central nervous system injury, Dr. Alter will ask them or their guardian about their seizure history
EXCLUSION CRITERIA:
Individuals with neuromuscular disorders and Healthy Volunteers, who meets any of the following criteria will be excluded from participation in this study:
- Individuals with pacemakers
- Pregnancy
- Adults unable to provide informed consent
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: CASE_CONTROL
- Časové perspektivy: OTHER
Kohorty a intervence
Skupina / kohorta |
|---|
|
healthy volunteer
Normal/healthy volunteers |
|
Impaired volunteer
volunteers with impairments of the neuromusculoskeletal system. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Gait Kinematics
Časové okno: end of testing
|
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. |
end of testing
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Katharine E Alter, M.D., National Institutes of Health Clinical Center (CC)
Publikace a užitečné odkazy
Obecné publikace
- Murray MP. Gait as a total pattern of movement. Am J Phys Med. 1967 Feb;46(1):290-333. No abstract available.
- 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.
- 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.
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhadovaný)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 900168
- 90-CC-0168
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Protocol is silent on IPD sharing.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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