- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01361867
Robotic Assessment of Lower Extremity Motor Learning
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The study is divided into two phases.
In phase I of the study, we intend to assess the response of individuals to a variety of different mechanical perturbations generated by a robotic system for treadmill-based gait training (Lokomat by Hocoma AG). Such response is quantified as a displacement from the baseline (i.e. gait cycles with no mechanical perturbation) trajectory of motion of the foot during the swing phase of the gait cycle. This portion of the study is expected to allow us to identify mechanical perturbations that are suitable to study motor adaptation.
In phase II of the study, we plan to carry out experiments using the above-mentioned robotic system to assess the magnitude of the motor adaptation to the mechanical perturbations identified in phase I as suitable for the study. The magnitude of the motor adaptation is quantified as the percentage of the deviation from the baseline trajectory of motion of the foot that subjects compensate for when exposed to the perturbation during multiple consecutive gait cycles.
It is worth noticing that the robotic system utilized to generate the mechanical perturbations (i.e. Lokomat by Hocoma AG) is not programmed by the company to generate the mechanical perturbations evaluated in this project. Our research group wrote the programs to generate such perturbations. It is also worth emphasizing that the 510K FDA clearance does not cover the modifications implemented by our research group.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02129
- Spaulding Rehabilitation Hospital Boston
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Males and females, healthy adults age 18-55 years, with normal gait.
Exclusion Criteria:
- Lower extremity fractures
- Current or previous history of orthopedic injury that would prevent safe use of the robotic system
- Body/femoral length size beyond the limits of robotic system (femur length between 350-470mm)
- Body weight > 135kg (~298 lbs) maximum limit of the body weight support system
- Skin lesions on the lower extremities
- Cardiovascular or pulmonary contraindications
- Motor system or proprioceptive impairments
- Severe cognitive impairments that would prevent the use of the robotic system
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: Robot-induced perturbations
The subject walks on a treadmill with his/her legs strapped to a robotic system (Lokomat by Hocoma AG) that generates mechanical perturbations aimed to modify the subject's walking pattern.
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A robotic system is used to generate mechanical perturbations and study how subjects generate motor adaptations in response to the mechanical perturbations.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Step Length Adaptation
Tidsramme: within a trial of the experiment (i.e. a few minutes)
|
The percentage of the step length change caused by the mechanical perturbation that subjects compensate for
|
within a trial of the experiment (i.e. a few minutes)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Step Height Adaptation
Tidsramme: within a trial of the experiment (i.e. a few minutes)
|
The percentage of the step height change caused by the mechanical perturbation that subjects compensate for
|
within a trial of the experiment (i.e. a few minutes)
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2009-P-002030
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
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Kliniske forsøg med Robot-induced perturbations
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Vicki GrayAfsluttet
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Mayo ClinicAndersen FoundationAfsluttet
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VA Office of Research and DevelopmentAfsluttet
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Lynn Snyder-MacklerAfsluttet
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Foundation University IslamabadAfsluttetSlag | Erkendelse | Balance | FaldrisikoPakistan
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University of Illinois at ChicagoNational Institute on Aging (NIA); Roybal Predoctoral pilot grantRekrutteringMild kognitiv svækkelse | Alderdom; SvaghedForenede Stater
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University of Illinois at ChicagoNational Institute on Aging (NIA)Rekruttering
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Mahatma Gandhi Institute of Medical SciencesAfsluttet
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University of BirminghamAfsluttet
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US Department of Veterans AffairsAfsluttet