Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
106 participants
OBSERVATIONAL
2017-01-31
2018-09-30
Brief Summary
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Detailed Description
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The validation involves two stages:
The first stage, carried out in the clinical setting, provides the use of Actigraphs (Actigraph GXT3+ and in a subgroup also FitBit) during the administration of clinical tests which are usually performed for the evaluation of the manual dominance in individuals with hemiplegia but also suitable for those with typical development.
This first phase will allow to compare the quantitative measures acquired by the actigraphs (e.g. the mean activity of each hand and the asymmetry index i.e. difference between the mean activities of the two arms) with those from clinical standardized measures.
The second phase, carried out in a non-clinical setting, provides the use of Actigraphs (Actigraph GXT3+ and in a subgroup also FitBit) in a subgroup of subject involved in the first phase for a week in order to measure the asymmetry index during the activities of daily living.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Experimental group
Children, Adolescents and Young with hemiplegia
Actigraph
Actigraphs worn on wrists
Control group
Children, Adolescents and Young with typical development
Actigraph
Actigraphs worn on wrists
Interventions
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Actigraph
Actigraphs worn on wrists
Eligibility Criteria
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Inclusion Criteria
* Hemiplegia (experimental group) or Voluntary adhesion (control group)
Exclusion Criteria
* sensory deficits
3 Years
25 Years
ALL
Yes
Sponsors
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Scuola Superiore Sant'Anna di Pisa
OTHER
The University of Queensland
OTHER
Ministry of Health, Italy
OTHER_GOV
IRCCS Fondazione Stella Maris
OTHER
Responsible Party
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Principal Investigators
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Giuseppina Sgandurra, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
IRCCS Fondazione Stella Maris
Locations
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IRCCS Stella Maris Foundation
Calambrone, Pisa, Italy
Countries
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References
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Martin JL, Hakim AD. Wrist actigraphy. Chest. 2011 Jun;139(6):1514-1527. doi: 10.1378/chest.10-1872.
Nagels G, Marion P, Pickut BA, Timmermans L, De Deyn PP. Actigraphic evaluation of handedness. Electroencephalogr Clin Neurophysiol. 1996 Jun;101(3):226-32. doi: 10.1016/0924-980x(96)95566-6.
Beani E, de 'Cavalieri MF, Filogna S, Barzacchi V, Cianchetti M, Maselli M, Martini G, Menici V, Prencipe G, Sicola E, Cioni G, Sgandurra G. Wearable sensors for measuring spontaneous upper limb use in children with unilateral cerebral palsy and typical development. J Neuroeng Rehabil. 2025 Apr 3;22(1):71. doi: 10.1186/s12984-025-01601-3.
Beani E, Maselli M, Sicola E, Perazza S, Cecchi F, Dario P, Braito I, Boyd R, Cioni G, Sgandurra G. Actigraph assessment for measuring upper limb activity in unilateral cerebral palsy. J Neuroeng Rehabil. 2019 Feb 22;16(1):30. doi: 10.1186/s12984-019-0499-7.
Other Identifiers
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GR-2011-02350053
Identifier Type: -
Identifier Source: org_study_id
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