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