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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02878304
Acronym
ProHand
Enrollment
100
Registered
2016-08-25
Start date
2013-03-31
Completion date
2017-12-31
Last updated
2016-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemiparesis, Stroke

Keywords

Prognosis, Hand function, Rehabilitation, Spasticity, MRI

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.

Interventions

None listed

Sponsors

Danderyd Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Change in Fugl-Meyer Assessment for Upper ExtremityFrom 4 weeks to 3 and six months

Other

MeasureTime frameDescription
Change in NeuroFlexor(C) measuresFrom 4 weeks to 3 and 6 monthsQuantitative measures of the neural and biomechanical components of the force resisting passive movement of ther wrist
Change in modulation of gripforce: Visuomotor grip force tracking taskFrom 4 weeks to 3 and 6 months
Change in Action Research Arm Test, ARATFrom 4 weeks to 3 and 6 months
Structural and functional connectivity measures; functional Magnetic Resonance ImagingFrom 4 weeks to 6 months
Change in grip forceFrom 4 weeks to 3 and 6 monthsDynamometry
Change in Assisting Hand Assessment, AHAFrom 4 weeks to 3 and 6 monthsMeasures of the spontaneous use of the more affected hand in specific bimanual activities
Change in Box and Block Task, BBTFrom 4 weeks to 3 and 6 months
Change in Strength-Dexterity testFrom 4 weeks to 3 and 6 monthsDexterous ability/quantification of precision in finger movements

Countries

Sweden

Contacts

Primary ContactJeanette AM Plantin, PhD student
jeanette.plantin@ki.se0046709169232
Backup ContactPåvel G Lindberg, Ass. Prof.
pavel.lindberg@ki.se0033140789244

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026