StrokeSALGOTNCT01115348
SALGOT; Stroke Arm Longitudinal Study at the University of GOThenburg
An observational study of Stroke and Motor Activity, run by Göteborg University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Motor Activity
- How many people
- 120 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2009to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The group consists of consecutively included persons from stroke units (Sahlgrenska University Hospital)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stroke Arm Longitudinal Study at the University of Gothenburg;SALGOT
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.
Read the 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
- Conditions
- Stroke, Motor Activity
- Medical subject headings
- Stroke, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper extremity function
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startMar 2009
- Primary completionDec 2011
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katharina Stibrant Sunnerhagen, MD, PhD, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115348
- Sponsor's protocol ID
- SALGOT
- Acronym
- SALGOT
- Status last verified
- Feb 2017
- First submitted
- 3 May 2010
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Thrane G, Sunnerhagen KS, Murphy MA. Upper limb kinematics during the first year after stroke: the stroke arm longitudinal study at the University of Gothenburg (SALGOT). J Neuroeng Rehabil. 2020 Jun 15;17(1):76. doi: 10.1186/s12984-020-00705-2.
PubMed 32539738Ghaziani E, Couppe C, Siersma V, Christensen H, Magnusson SP, Sunnerhagen KS, Persson HC, Alt Murphy M. Easily Conducted Tests During the First Week Post-stroke Can Aid the Prediction of Arm Functioning at 6 Months. Front Neurol. 2020 Jan 9;10:1371. doi: 10.3389/fneur.2019.01371. eCollection 2019.
PubMed 31993016Hussain N, Sunnerhagen KS, Alt Murphy M. End-point kinematics using virtual reality explaining upper limb impairment and activity capacity in stroke. J Neuroeng Rehabil. 2019 Jul 1;16(1):82. doi: 10.1186/s12984-019-0551-7.
PubMed 31262320Thrane G, Alt Murphy M, Sunnerhagen KS. Recovery of kinematic arm function in well-performing people with subacute stroke: a longitudinal cohort study. J Neuroeng Rehabil. 2018 Jul 18;15(1):67. doi: 10.1186/s12984-018-0409-4.
PubMed 30021596Hussain N, Alt Murphy M, Sunnerhagen KS. Upper Limb Kinematics in Stroke and Healthy Controls Using Target-to-Target Task in Virtual Reality. Front Neurol. 2018 May 9;9:300. doi: 10.3389/fneur.2018.00300. eCollection 2018.
PubMed 29867717Olsson OA, Persson HC, Alt Murphy M, Sunnerhagen KS. Early prediction of physical activity level 1 year after stroke: a longitudinal cohort study. BMJ Open. 2017 Aug 4;7(8):e016369. doi: 10.1136/bmjopen-2017-016369.
PubMed 28780554Persson HC, Danielsson A, Sunnerhagen KS. A cross sectional study of upper extremity strength ten days after a stroke; relationship between patient-reported and objective measures. BMC Neurol. 2015 Oct 1;15:178. doi: 10.1186/s12883-015-0436-8.
PubMed 26427533Persson HC, Alt Murphy M, Danielsson A, Lundgren-Nilsson A, Sunnerhagen KS. A cohort study investigating a simple, early assessment to predict upper extremity function after stroke - a part of the SALGOT study. BMC Neurol. 2015 Jun 18;15:92. doi: 10.1186/s12883-015-0349-6.
PubMed 26084397Alt 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. doi: 10.1186/1471-2377-11-56.
PubMed 21612620
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke Arm Longitudinal Study at the University of Gothenburg;SALGOT
- ClinicalTrials.gov ID
- NCT01115348
- Acronym / sponsor ID
- SALGOT / SALGOT
- Conditions
- Stroke, Motor Activity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2017 (estimated)
- First posted
- 4 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The group consists of consecutively included persons from stroke units (Sahlgrenska University Hospital)
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Upper extremity function
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2017.
- Derived from this study: PubMed 32539738Thrane G, Sunnerhagen KS, Murphy MA. Upper limb kinematics during the first year after stroke: the stroke arm longitudinal study at the University of Gothenburg (SALGOT). J Neuroeng Rehabil. 2020 Jun 15;17(1):76. doi: 10.1186/s12984-020-00705-2.
- Derived from this study: PubMed 31993016Ghaziani E, Couppe C, Siersma V, Christensen H, Magnusson SP, Sunnerhagen KS, Persson HC, Alt Murphy M. Easily Conducted Tests During the First Week Post-stroke Can Aid the Prediction of Arm Functioning at 6 Months. Front Neurol. 2020 Jan 9;10:1371. doi: 10.3389/fneur.2019.01371. eCollection 2019.
- Derived from this study: PubMed 31262320Hussain N, Sunnerhagen KS, Alt Murphy M. End-point kinematics using virtual reality explaining upper limb impairment and activity capacity in stroke. J Neuroeng Rehabil. 2019 Jul 1;16(1):82. doi: 10.1186/s12984-019-0551-7.
- Derived from this study: PubMed 30021596Thrane G, Alt Murphy M, Sunnerhagen KS. Recovery of kinematic arm function in well-performing people with subacute stroke: a longitudinal cohort study. J Neuroeng Rehabil. 2018 Jul 18;15(1):67. doi: 10.1186/s12984-018-0409-4.
- Derived from this study: PubMed 29867717Hussain N, Alt Murphy M, Sunnerhagen KS. Upper Limb Kinematics in Stroke and Healthy Controls Using Target-to-Target Task in Virtual Reality. Front Neurol. 2018 May 9;9:300. doi: 10.3389/fneur.2018.00300. eCollection 2018.
- Derived from this study: PubMed 28780554Olsson OA, Persson HC, Alt Murphy M, Sunnerhagen KS. Early prediction of physical activity level 1 year after stroke: a longitudinal cohort study. BMJ Open. 2017 Aug 4;7(8):e016369. doi: 10.1136/bmjopen-2017-016369.
- Derived from this study: PubMed 26427533Persson HC, Danielsson A, Sunnerhagen KS. A cross sectional study of upper extremity strength ten days after a stroke; relationship between patient-reported and objective measures. BMC Neurol. 2015 Oct 1;15:178. doi: 10.1186/s12883-015-0436-8.
- Derived from this study: PubMed 26084397Persson HC, Alt Murphy M, Danielsson A, Lundgren-Nilsson A, Sunnerhagen KS. A cohort study investigating a simple, early assessment to predict upper extremity function after stroke - a part of the SALGOT study. BMC Neurol. 2015 Jun 18;15:92. doi: 10.1186/s12883-015-0349-6.
- Derived from this study: PubMed 21612620Alt 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. doi: 10.1186/1471-2377-11-56.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katharina Stibrant Sunnerhagen, MD, PhD principal investigator
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Motor Activity, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper extremity function (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01115348, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2017.