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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01935687 |
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Date of registration:
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04/03/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Clinical Evaluation of Instrumented Wheel as Biomedical Device Quantifying the Displacement Efficiency
FRM |
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Scientific title:
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Clinical Evaluation of Instrumented Wheel of Wheelchair as Biomedical Device Quantifying the Displacement Efficiency |
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Date of first enrolment:
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December 2012 |
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Target sample size:
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62 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01935687 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Djamel Bensmail, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE, 92380 Garches, France |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age : 18-70 years.
- Spinal cord injured patient.
- User of manual wheelchair for daily locomotion (having at least 30/100 at displacement
items of WST questionnaire) .
- Affiliation to a social security scheme or entitled.
- Informed consent dated and signed by subject or subject's legally acceptable
representative (and investigator).
Exclusion Criteria:
- Cognitive troubles.
- Progressive diseases: Tumoral, infectious, inflammatory and associated pathologies:
brain injury, amputation.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Spinal Cord Injury
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Intervention(s)
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Device: Using of ergometer roller
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Device: Using of instrumented wheel
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Primary Outcome(s)
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Mechanical power calculated by instrumented wheel and ergometer roller.
[Time Frame: 20 min]
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Secondary Outcome(s)
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Efficient fraction of total power calculated using instrumented wheel
[Time Frame: 6 min]
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Efficient fraction of total power calculated using ergometer roller
[Time Frame: 15 min]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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