SALGOT; Stroke Arm Longitudinal Study at the University of GOThenburg

Stroke Clinical Trial

— SALGOT  

Official title:

Stroke Arm Longitudinal Study at the University of Gothenburg;SALGOT

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01115348
• Other study ID #: SALGOT
• Status: Active, not recruiting
• Phase: N/A
• First received: May 3, 2010
• Last updated: February 1, 2017
• Start date: March 2009
• Est. completion date: December 2017

Study information

• Verified date: February 2017
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 2017
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Motor Activity
• Stroke

Locations

Country	Name	City	State
Sweden	Stroke Unit, Sahlgrenska University Hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Upper extremity function		12 months