Eva-Hip, Evaluation of Rehabilitation After Hip-fracture
This study is currently recruiting participants.
Verified September 2011 by Norwegian University of Science and Technology
Sponsor:
Norwegian University of Science and Technology
Collaborators:
Trondheim kommune, enhet for fysioterapi
Norsk kvinners sanitetsforening
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01379456
First received: June 15, 2011
Last updated: September 6, 2011
Last verified: September 2011
| Tracking Information | |||||||||
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| First Received Date ICMJE | June 15, 2011 | ||||||||
| Last Updated Date | September 6, 2011 | ||||||||
| Start Date ICMJE | February 2011 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
change in gait speed [ Time Frame: 4,6 and 12 months postfracture ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01379456 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
change in activity level [ Time Frame: 4,6 and 12 month postfracture ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Eva-Hip, Evaluation of Rehabilitation After Hip-fracture | ||||||||
| Official Title ICMJE | The Effect on Gait and Activity Level of a Physiotherapy Intervention Aimed at Improving Mediolateral Stability 4 Months After a Hip Fracture | ||||||||
| Brief Summary | To evaluate the effect on gait and activity of a home based physiotherapy intervention 4-6 months after the fracture. The investigators hypothesis is that exercises performed after the initial rehabilitation, which focuses on specific components of gait control will improve gait and increase level of activity. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Hip Fracture | ||||||||
| Intervention ICMJE | Procedure: physiotherapy
exercises, 20 sessions over 10 weeks |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 100 | ||||||||
| Estimated Completion Date | December 2014 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 70 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Norway | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01379456 | ||||||||
| Other Study ID Numbers ICMJE | REK 2010/3265-3 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Norwegian University of Science and Technology | ||||||||
| Study Sponsor ICMJE | Norwegian University of Science and Technology | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Norwegian University of Science and Technology | ||||||||
| Verification Date | September 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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