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

Stroke Clinical Trial

— ProHand  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02878304
• Other study ID #: PROHAND_001
• Status: Recruiting
• Phase: N/A
• First received: August 22, 2016
• Last updated: August 22, 2016
• Start date: March 2013
• Est. completion date: December 2017

Study information

• Verified date: August 2016
• Source: Danderyd Hospital
• Contact: Jeanette AM Plantin, PhD student
• Phone: 0046709169232
• Email: jeanette.plantin[@]ki.se
• Is FDA regulated: No
• Health authority: Sweden: Swedish Research CouncilSweden: The National Board of Health and Welfare
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hemiparesis
• Paresis
• Stroke

Locations

Country	Name	City	State
Sweden	Danderyd University Hospital	Stockholm	Danderyd

Sponsors (1)

Lead Sponsor	Collaborator
Danderyd Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Structural and functional connectivity measures; functional Magnetic Resonance Imaging		From 4 weeks to 6 months	No
Other	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	No
Other	Change in modulation of gripforce: Visuomotor grip force tracking task		From 4 weeks to 3 and 6 months	No
Other	Change in Action Research Arm Test, ARAT		From 4 weeks to 3 and 6 months	No
Other	Change in Strength-Dexterity test	Dexterous ability/quantification of precision in finger movements	From 4 weeks to 3 and 6 months	No
Other	Change in grip force	Dynamometry	From 4 weeks to 3 and 6 months	No
Other	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	No
Other	Change in Box and Block Task, BBT		From 4 weeks to 3 and 6 months	No
Primary	Change in Fugl-Meyer Assessment for Upper Extremity		From 4 weeks to 3 and six months	No