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

• Conditions: Stroke; Hemiparesis

• Registration Number: NCT02878304
• Lead Sponsor: Danderyd Hospital

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.

Study Timeline

• Study Start: 2013-03
• Status Verified: 2016-08
• Study First Submitted: 2016-08-22
• Study First Submitted QC: 2016-08-22
• Last Update Submitted: 2016-08-22
• Study First Posted: 2016-08-25
• Last Update Posted: 2016-08-25
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Fugl-Meyer Assessment for Upper Extremity	From 4 weeks to 3 and six months

Trial Locations

Locations (1)

Danderyd University Hospital; 🇸🇪 Stockholm, Danderyd, Sweden