Clinical trial NCT03054441: Actigraphs for Detection of Asymmetries
Official title: Detection of Asymmetries in Upper Limb Use Through Actigraphs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemiplegia
Hemiplegic Cerebral Palsy
Keywords: Upper limb
Inertial sensors
Lead sponsor: IRCCS Fondazione Stella Maris
Sponsor class: OTHER
Collaborators: name: Scuola Superiore Sant'Anna di Pisa
name: The University of Queensland
name: Ministry of Health, Italy
First posted: 2017-02-15
Enrollment: 106
Sex: ALL
Minimum age (years): 3
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children, Adolescents and Adults with hemiplegia and age-matched controls with typical development

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Age between 3-25 years
* Hemiplegia (experimental group) or Voluntary adhesion (control group)

Exclusion Criteria:

* movement disorders
* sensory deficits

Primary outcomes:
measure: Correlation between Asymmetry Index (AI) and Assisting Hand Assessment (AHA) scores.
timeFrame: Baseline
Secondary outcomes:
measure: Correlation between AI during AHA and AI in 7 days
timeFrame: Baseline- 1 week
Other outcomes:
measure: Correlation between Box and Block test (BBT) and mean activity of dominant and non dominant hand
timeFrame: Baseline
measure: Correlation among Mean activity and asymmetry index during standardized clinical activities.
timeFrame: Baseline
Locations:
city: Calambrone
country: Italy
facility: IRCCS Stella Maris Foundation
state: Pisa
Study officials:
affiliation: IRCCS Fondazione Stella Maris
name: Giuseppina Sgandurra, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martin JL, Hakim AD. Wrist actigraphy. Chest. 2011 Jun;139(6):1514-1527. doi: 10.1378/chest.10-1872.
citation: 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.
citation: 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.