Clinical Trials Directory

Trials / Completed

CompletedNCT03054441

Actigraphs for Detection of Asymmetries

Detection of Asymmetries in Upper Limb Use Through Actigraphs

Status
Completed
Phase
Study type
Observational
Enrollment
106 (actual)
Sponsor
IRCCS Fondazione Stella Maris · Academic / Other
Sex
All
Age
3 Years – 25 Years
Healthy volunteers
Accepted

Summary

In hemiplegia quantitatively measurement of the asymmetry in the use of upper limbs could overcome the limitation of many outcome measures in which scores are dependent on the experience and training of the therapist. The main aim of this study was to determine the validity of Actigraph GXT3+ to measure asymmetry in the use of the two upper limbs during the Assisting Hand Assessment (AHA) in children, adolescents and young with hemiplegia aged 5-19 years, compared to age-matched typically developing subjects (TD).

Detailed description

This study aims to validate the use of Actigraphs as an evaluation tool of the upper limb asymmetry in children / adolescents and young adults with typical development or hemiplegia. 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

Interventions

TypeNameDescription
OTHERActigraphActigraphs worn on wrists

Timeline

Start date
2017-01-01
Primary completion
2018-07-01
Completion
2018-09-01
First posted
2017-02-15
Last updated
2018-09-14

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT03054441. Inclusion in this directory is not an endorsement.