- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00785278
Adjusting Wheelchair Set-Up to Minimize Shoulder Joint Forces During Propulsion
Computationally Quantifying Wheelchair Set-Up to Minimize Peak Shoulder Joint Forces Throughout Manual Wheelchair Propulsion: A Pilot Study
Individuals who use a manual wheelchair depend upon their upper limbs to provide a means of locomotion during completion of their activities of daily living. As a result of greater than normal usage of the upper limbs, shoulder pain and pathology is common among manual wheelchair users. Accordingly, proper wheelchair set-up may be paramount to preventing injuries and maintaining comfort during locomotion.
The purpose of this research study is to create a subject-specific computer model of wheelchair propulsion to provide information on wheelchair set-up (in particular, axle placement). The primary objective of this study is to investigate the effect of wheelchair set-up on shoulder joint forces during wheelchair propulsion; the secondary objective is to develop a predictive model to identify differences in shoulder joint forces that result from altering the axle position and seating set-up in user's wheelchairs.
The hypothesis of the study is that outputs from a patient-specific model will reveal that the current axle position for each subject results in peak shoulder joint forces that are greater than those predicted from an altered axle position (determined by the model). The overall goal is to then adjust each manual wheelchair user's axle placement to one that minimizes the magnitude of shoulder joint forces throughout propulsion. It is intended that in doing so, the repetitive strain injuries associated with manual wheelchair propulsion may be reduced, prolonging a pain-free way of life for this population.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Studijní místa
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New Jersey
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West Orange, New Jersey, Spojené státy, 07052
- Nábor
- Kessler Medical Rehabilitation Research and Education Center
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Dílčí vyšetřovatel:
- Trevor A. Dyson-Hudson, M.D.
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Kontakt:
- Sarah R. Dubowsky, Ph.D.
- Telefonní číslo: 973-243-6838
- E-mail: sdubowsky@kmrrec.org
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Kontakt:
- Andrew M. Kwarciak, M.S.
- Telefonní číslo: 973-243-6903
- E-mail: akwarciak@kmrrec.org
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Vrchní vyšetřovatel:
- Sarah R. Dubowsky, Ph.D.
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Dílčí vyšetřovatel:
- Gail F. Forrest, Ph.D.
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Dílčí vyšetřovatel:
- Andrew M. Kwarciak, M.S.
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Dílčí vyšetřovatel:
- Mathew B. Yarossi, B.S.
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Dílčí vyšetřovatel:
- Arvind Ramanujam, M.S.
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Experienced Wheelchair Users:
Inclusion Criteria:
- Have a neurological impairment secondary to a spinal cord injury which occurred over 1 year prior to the start of the study;
- SCI at or below T1 (complete or incomplete);
- Use a manual wheelchair as a primary means of mobility (at least 40 hrs. per week but not necessarily always in motion);
- SCI after age 18
- Have 24 inch diameter wheels with quick-release axles.
Exclusion Criteria:
- History of fractures or dislocations in the arms including the shoulder, elbow, and wrist;
- Upper limb dysthetic pain as a result of a syrinx or reflex sympathetic dystrophy;
- Pregnant women;
- Shoulder pain that a MWU describes as limiting their ability to propel a manual wheelchair;
- History of neurologic disorder other than spinal cord injury (e.g. brain injury).
Inexperienced Manual Wheelchair Users:
Inclusion Criteria:
- Be between the ages of 18 and 65 years of age.
Exclusion Criteria:
- History of fractures or dislocations in the arms including the shoulder, elbow, and wrist;
- Have a musculoskeletal disorder;
- Pregnant women;
- Shoulder pain that limits their ability to propel a manual wheelchair.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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1
Able-bodied participants: Able-bodied individuals will be asked to propel a wheelchair at a self-selected speed for a period of time during which data will be collected on their propulsion biomechanics.
It is assumed, for the purpose of the study, that un-learned able-bodied individuals learning to propel a wheelchair reflect newly injured individuals who are just getting accustomed to a new chair.
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2
Participants with paraplegia: Individuals who are at least 1-year post injury and have used a manual wheelchair as their primary means of locomotion during this time, will be assumed to be, for the purpose of this study, experienced wheelchair users.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
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Peak shoulder joint forces
Časové okno: During the propulsive phase of the push stroke at the time of data collection
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During the propulsive phase of the push stroke at the time of data collection
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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
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Propulsion Speed
Časové okno: Measured during the data collection process
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Measured during the data collection process
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Horizontal and Vertical Axle Placement
Časové okno: Measured prior to data collection on each test day
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Measured prior to data collection on each test day
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Sarah R. Dubowsky, Ph.D., Kessler Medical Rehabilitation Research and Education Center
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
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
- R-619-08
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