SALGOT; Stroke Arm Longitudinal Study at the University of GOThenburg - Full Text View

Sponsor:	Göteborg University
Information provided by:	Göteborg University
ClinicalTrials.gov Identifier:	NCT01115348

Purpose

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.

Condition
To Assess Recovery by Traditional Measures and New IT Technology as Well as Subjective Assessment of the Arm-hand Function Over the First Year After Stroke.

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective

Further study details as provided by Göteborg University:

Estimated Enrollment:	120
Study Start Date:	March 2009
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

The group consists of consecutively included persons from stroke units (Sahlgrenska University Hospital)

Criteria

Inclusion Criteria:

first occurrence of a stroke will be included and followed longitudinally for one year after the stroke.
Reduced UE function on the M-MAS UAS-95 on day 2 after stroke > 18 years of age

Exclusion Criteria:

Other disease/injury that affect upper extremity function
Life expectancy less than 12 months (study time)
Not able to communicate in Swedish
Not living in the catchment area of the hospital

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01115348

Locations

Sweden
Stroke Unit, Sahlgrenska University Hospital	Recruiting
Gothenburg, Sweden
Contact: Margit AtlMurphy, PT margit.alt-murphy@vgregion.se
Contact: Hanna Svensson, PT
Principal Investigator: Katharina Stibrant Sunnerhagen, Professor

Sponsors and Collaborators

Göteborg University

More Information

No publications provided by Göteborg University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Professor Katharina Stibrant Sunnerhagen, Universtiy of Gothenburg, Institute of Neuroscience and Physiology, Section for Clinical Neuroscience and Rehabiliation
ClinicalTrials.gov Identifier:	NCT01115348 History of Changes
Other Study ID Numbers:	SALGOT
Study First Received:	May 3, 2010
Last Updated:	May 3, 2010
Health Authority:	Centrala etikprövningsnämnden, webmaster@epn.se ':' SWEDEN':'

Additional relevant MeSH terms:

Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases

Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 24, 2012