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Actigraphs for Detection of Asymmetries

I

IRCCS Fondazione Stella Maris

Status

Completed

Conditions

Hemiplegia
Hemiplegic Cerebral Palsy

Treatments

Other: Actigraph

Study type

Observational

Funder types

Other

Identifiers

NCT03054441
GR-2011-02350053

Details and patient eligibility

About

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).

Full 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.

Enrollment

106 patients

Sex

All

Ages

3 to 25 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • movement disorders
  • sensory deficits

Trial design

106 participants in 2 patient groups

Experimental group
Description:
Children, Adolescents and Young with hemiplegia
Treatment:
Other: Actigraph
Control group
Description:
Children, Adolescents and Young with typical development
Treatment:
Other: Actigraph

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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