- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00011609
Clinical Evaluation of a Wheelchair Mounted Robotic Arm
The primary purpose of this project, is to evaluate the effect of a wheelchair mounted robotic arm (WMRA) to improve the functional independence of veterans with SCI.
The study will determine if the ability to perform marker tasks within the following four categories is improved after the 4 week training period using the robotic arm:
1. activities of daily living, 2. vocational tasks, 3. advanced tasks, and subject-specific tasks.
Studieoversigt
Detaljeret beskrivelse
The primary purpose of this project, is to evaluate the effect of a wheelchair mounted robotic arm (WMRA) to improve the functional independence of veterans with SCI.
The study will determine if the ability to perform marker tasks within the following four categories is improved after the 4 week training period using the robotic arm:
1. activities of daily living, 2. vocational tasks, 3. advanced tasks, and subject-specific tasks.
The secondary purposes of this project are the following: 1.Does quality of life (life satisfaction and health status) improve after a 4 week period of using the WMRA? 2. What are the perceived advantages of the WMRA to the veteran with SCI? Additionally, the study will evaluate the following: 1) ease of installation and usefulness of instructional manuals; 2) training requirements (time, tasks); 3) safety features; 4) reliability of the device; 5) home, community, and vocational applications; 6) user acceptability; 7) maintenance/ service; 8) portability; and possible modifications.
Undersøgelsestype
Tilmelding
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Texas
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Houston, Texas, Forenede Stater
- VAMC, Houston
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Samarbejdspartnere og efterforskere
Efterforskere
- John Fryer, Ph.D. Asst. Director, Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
- Nancy Rocheleau, Program Analyst, Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- B2311T
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