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

NCT ID: NCT02878304

Last Updated: 2016-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Stroke Hemiparesis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danderyd Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jörgen Borg, Professor

Role: STUDY_DIRECTOR

Department of Rehabilitation Medicine, Danderyd University Hospital, Karolinska Institutet

Locations

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Danderyd University Hospital

Stockholm, Danderyd, Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Jeanette AM Plantin, PhD student

Role: CONTACT

0046709169232

Påvel G Lindberg, Ass. Prof.

Role: CONTACT

0033140789244

Facility Contacts

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Jeanette Plantin, PhD stud.

Role: primary

00467969495796

References

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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.

Reference Type DERIVED
PMID: 34400568 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33493822 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31906829 (View on PubMed)

Other Identifiers

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PROHAND_001

Identifier Type: -

Identifier Source: org_study_id

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