Clinical trial NCT02878304: Biomarkers for Prediction of Hand Function After Stroke - The ProHand Study
Official title: Recovery of Hand Function After Stroke- a Longitudinal Study Using Novel Methods to Quantify Hand Function and Connectivity in Brain Networks
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Hemiparesis
Keywords: Prognosis
Hand function
Rehabilitation
Spasticity
MRI
Lead sponsor: Danderyd Hospital
Sponsor class: OTHER
First posted: 2016-08-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients are recruited at entry to a specialized sub-acute rehabilitation unit after first time stroke

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Fugl-Meyer Assessment for Upper Extremity
timeFrame: From 4 weeks to 3 and six months
Secondary outcomes:
Other outcomes:
measure: Structural and functional connectivity measures; functional Magnetic Resonance Imaging
timeFrame: From 4 weeks to 6 months
measure: Change in NeuroFlexor(C) measures
timeFrame: From 4 weeks to 3 and 6 months
measure: Change in modulation of gripforce: Visuomotor grip force tracking task
timeFrame: From 4 weeks to 3 and 6 months
measure: Change in Action Research Arm Test, ARAT
timeFrame: From 4 weeks to 3 and 6 months
measure: Change in Strength-Dexterity test
timeFrame: From 4 weeks to 3 and 6 months
measure: Change in grip force
timeFrame: From 4 weeks to 3 and 6 months
measure: Change in Assisting Hand Assessment, AHA
timeFrame: From 4 weeks to 3 and 6 months
measure: Change in Box and Block Task, BBT
timeFrame: From 4 weeks to 3 and 6 months
Locations:
city: Stockholm
country: Sweden
facility: Danderyd University Hospital
state: Danderyd
Study officials:
affiliation: Department of Rehabilitation Medicine, Danderyd University Hospital, Karolinska Institutet
name: Jörgen Borg, Professor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Hybbinette H, Ostberg 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.
citation: 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.