SALGOT; Stroke Arm Longitudinal Study at the University of GOThenburg
| Tracking Information | |||||
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| First Received Date ICMJE | May 3, 2010 | ||||
| Last Updated Date | August 28, 2012 | ||||
| Start Date ICMJE | March 2009 | ||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01115348 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | SALGOT; Stroke Arm Longitudinal Study at the University of GOThenburg | ||||
| Official Title ICMJE | Stroke Arm Longitudinal Study at the University of Gothenburg;SALGOT | ||||
| Brief Summary | Stroke is the most common cause for motor disability in the grown-up population in the Western world. In Sweden > 80 % are above 65 years of age at onset (1).Areas in the brain, controlling the movement in the upper extremity (UE) are often damaged at a stroke, which leads to impaired function. This impairment of the UE often leads to limitations in activities of daily living and reductions in the level of social activities; therefore, interventions that will improve function are needed to reduce the consequences for the person living with stroke. The time course of recovery of the UE is not clear and therefore the optimal timing of the intervention for the person and its content (ways of intervention) uncertain. The investigators have developed objective assessments of motor performance with new technology (kinematic analysis and virtual reality with haptics). Since having an impaired UE often results in reduced capacity in daily living and social activities, this might lead to decreased participation. To complement the traditional focus on body function, there is a need for assessments of the person's activity level and participation, as well as self-perceived function. The results from this study will lay the ground for an intervention study focusing on improved function in the upper extremity. |
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| Detailed Description | Tools to objectively assess upper extremity function and activity Grippit: The handgrip force will be recorded, both the peak maximum grip force and the mean value of the ten-second sustained grip for the right hand Kinematics: An optoelectronic system is used for the three-dimensional motion analysis. This system includes an advanced optoelectronic camera system that produces clean and accurate 3D data. Ball shaped markers are positioned on the body, and reflect infrared light from camera flashes. Data analysis itself is performed with special software. The drinking task test is performed with the person sitting in a standardized manner ARAT (Action research Arm Test) is a performance test for UE function and dexterity. VR The user observes a 3D image displayed above the tabletop using stereographic shuttered glasses. The user is able to reach into a virtual space and interact with 3-dimensional objects, with a haptic device, which creates the illusion of manipulating virtual objects. Tool to assess self perceived function and activity ABILHAND is a questionnaire aiming to measure manual ability in chronic stroke. It is interview based and focused on perceived difficulty in everyday activities and contains unimanual and bimanual activities. Stroke Impact Scale (SIS) is a scale where the person replies on perceptions regarding life after the stroke.. Impact on participation and autonomy (IPA-E); is an instrument where the person estimates perceived handicap and autonomy for persons living in the community |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | The group consists of consecutively included persons from stroke units (Sahlgrenska University Hospital) |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Alt Murphy M, Persson HC, Danielsson A, Broeren J, Lundgren-Nilsson A, Sunnerhagen KS. SALGOT--Stroke Arm Longitudinal study at the University of Gothenburg, prospective cohort study protocol. BMC Neurol. 2011 May 25;11:56. | ||||
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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 | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 120 | ||||
| Estimated Completion Date | December 2014 | ||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Sweden | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01115348 | ||||
| Other Study ID Numbers ICMJE | SALGOT | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Katharina Stibrant Sunnerhagen, Göteborg University | ||||
| Study Sponsor ICMJE | Göteborg University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Göteborg University | ||||
| Verification Date | August 2012 | ||||
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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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