Status:

UNKNOWN

Combining biomArkers and Tele-health Solutions for Delivering at Home and in the Community Precision Medicine for the Upper Limb in cHildren With HEMIplegia Due to Stroke

Lead Sponsor:

IRCCS Fondazione Stella Maris

Collaborating Sponsors:

Karolinska Institutet

Karlsruhe Institute of Technology

Conditions:

Congenital Hemiplegia

Unilateral Cerebral Palsy

Eligibility:

All Genders

6-18 years

Brief Summary

Paediatric (including perinatal) stroke has an incidence of between 1.3 and 13.0 per 100.000 yearly in Europe. 1/3 of children with neonatal and 50% of post-natal stroke will develop a hemiplegia with...

Detailed Description

Etiological causes of stroke in children are manifold and comprise both genetic and epigenetic factors but there are no reliable predictors for prevention or treatment strategies. Phenotypic variation...

Eligibility Criteria

Inclusion

  • mild to moderately severe impairment of upper limb function with minimal ability to grasp and hold objects with affected hand (MACS level I-IV);
  • no obvious motor dyspraxia or communication deficits as assessed by ability to imitate action with the non-paretic upper limb;
  • sufficient cooperation, cognitive and communicative understanding to perform assessments and participate in the intervention;
  • adequate attention, engagement and visual abilities to perform

Exclusion

  • severe or very minor UpL disability (MACS V);
  • Botulinum toxin-A injections in upper limb within 6 months prior to study entry;
  • upper limb surgery in UpL within 6 months prior to study entry

Key Trial Info

Start Date :

September 1 2023

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

September 30 2024

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT06012617

Start Date

September 1 2023

End Date

September 30 2024

Last Update

August 25 2023

Active Locations (1)

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1

Prof. Tarek Omar

Alexandria, Egypt