Biomarkers for Prediction of Hand Function After Stroke - The ProHand Study (ProHand)

Recovery of Hand Function After Stroke- a Longitudinal Study Using Novel Methods to Quantify Hand Function and Connectivity in Brain Networks

The overall aim is to identify key determinants for recovery of hand function after stroke by applying newly developed hand function measures together with MRI measurements of the lesioned cerebral structures.

Study Overview

• Status: Unknown
• Conditions: Stroke; Hemiparesis

Detailed Description

Almost half of surviving stroke patients are left with impaired function of the hand but individual profiles of weakness, spasticity, sensory and bimanual function vary widely. Improved prediction of recovery after stroke has broad implications for clinical decisions on the type, duration and goals of rehabilitation.

100 consecutive patients with 1st ever stroke and upper limb hemi-paresis will be subject to imaging, at 4 weeks and 6 months, and behavioral assessments at 4 weeks, 3 months and 6 months after stroke. The imaging protocol includes anatomical sequences for lesion mapping, diffusion tensor imaging and resting-state functional MRI for structural and functional connectivity analyses, respectively. Clinical hand function measures will be combined with novel validated methods to quantify spasticity,grip force control, sensory and bimanual function.

ProHand will provide insights into neural mechanisms related to recovery of hand function after stroke and enable enhanced prediction and development of targeted treatment trials.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Jeanette AM Plantin, PhD student; Phone Number: 0046709169232; Email: jeanette.plantin@ki.se
• Study Contact Backup: Name: Påvel G Lindberg, Ass. Prof.; Phone Number: 0033140789244; Email: pavel.lindberg@ki.se

Study Locations

• Sweden
  • Danderyd
    • Stockholm, Danderyd, Sweden, 18288
      • Recruiting
      • Danderyd University Hospital
      • Contact: Jeanette Plantin, PhD stud.; Phone Number: 00467969495796; Email: jeanette.plantin@ki.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients are recruited at entry to a specialized sub-acute rehabilitation unit after first time stroke

Description

Inclusion Criteria:

• first ever stroke and clinically diagnosed arm paresis

Exclusion Criteria:

• incapability to give informed concent and/or understand and comply with instructions, other disorders that may affect hand function (e.g. other neurological conditions, arthritis), cerebellar lesions.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Fugl-Meyer Assessment for Upper Extremity	From 4 weeks to 3 and six months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Structural and functional connectivity measures; functional Magnetic Resonance Imaging		From 4 weeks to 6 months
Change in NeuroFlexor(C) measures	Quantitative measures of the neural and biomechanical components of the force resisting passive movement of ther wrist	From 4 weeks to 3 and 6 months
Change in modulation of gripforce: Visuomotor grip force tracking task		From 4 weeks to 3 and 6 months
Change in Action Research Arm Test, ARAT		From 4 weeks to 3 and 6 months
Change in Strength-Dexterity test	Dexterous ability/quantification of precision in finger movements	From 4 weeks to 3 and 6 months
Change in grip force	Dynamometry	From 4 weeks to 3 and 6 months
Change in Assisting Hand Assessment, AHA	Measures of the spontaneous use of the more affected hand in specific bimanual activities	From 4 weeks to 3 and 6 months
Change in Box and Block Task, BBT		From 4 weeks to 3 and 6 months

Collaborators and Investigators

• Sponsor: Danderyd Hospital
• Investigators: Study Director: Jörgen Borg, Professor, Department of Rehabilitation Medicine, Danderyd University Hospital, Karolinska Institutet

Publications and helpful links

General Publications

• Plantin J, Verneau M, Godbolt AK, Pennati GV, Laurencikas E, Johansson B, Krumlinde-Sundholm L, Baron JC, Borg J, Lindberg PG. Recovery and Prediction of Bimanual Hand Use After Stroke. Neurology. 2021 Aug 17;97(7):e706-e719. doi: 10.1212/WNL.0000000000012366. Epub 2021 Jun 14. Erratum In: Neurology. 2022 Feb 22;98(8):341.
• Hybbinette H, Östberg P, Schalling E. Intra- and Interjudge Reliability of the Apraxia of Speech Rating Scale in Early Stroke Patients. J Commun Disord. 2021 Jan-Feb;89:106076. doi: 10.1016/j.jcomdis.2020.106076. Epub 2021 Jan 6.
• Pennati GV, Plantin J, Carment L, Roca P, Baron JC, Pavlova E, Borg J, Lindberg PG. Recovery and Prediction of Dynamic Precision Grip Force Control After Stroke. Stroke. 2020 Mar;51(3):944-951. doi: 10.1161/STROKEAHA.119.026205. Epub 2020 Jan 7.

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: August 22, 2016
• First Submitted That Met QC Criteria: August 22, 2016
• First Posted (Estimate): August 25, 2016

Study Record Updates

• Last Update Posted (Estimate): August 25, 2016
• Last Update Submitted That Met QC Criteria: August 22, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: MRI; Rehabilitation; Prognosis; Spasticity; Hand function
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Stroke; Paresis
• Other Study ID Numbers: PROHAND_001