NCT01115348

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 3, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 2, 2017

Status Verified

February 1, 2017

Enrollment Period

2.8 years

First QC Date

May 3, 2010

Last Update Submit

February 1, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Upper extremity function

    12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stroke Unit, Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Related Publications (9)

  • 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.

  • Ghaziani 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.

  • Hussain 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.

  • Thrane 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.

  • Hussain 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.

  • Olsson 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.

  • Persson 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.

  • Persson 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.

  • 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. doi: 10.1186/1471-2377-11-56.

MeSH Terms

Conditions

StrokeMotor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Study Officials

  • Katharina Stibrant Sunnerhagen, MD, PhD

    Göteborg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2010

First Posted

May 4, 2010

Study Start

March 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2017

Last Updated

February 2, 2017

Record last verified: 2017-02

Locations