Skip to content

Actigraphs for Detection of Asymmetries

Detection of Asymmetries in Upper Limb Use Through Actigraphs

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03054441
Enrollment
106
Registered
2017-02-15
Start date
2017-01-31
Completion date
2018-09-30
Last updated
2018-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemiplegia, Hemiplegic Cerebral Palsy

Keywords

Upper limb, Inertial sensors

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.

Interventions

Actigraphs worn on wrists

Sponsors

Scuola Superiore Sant'Anna di Pisa
CollaboratorOTHER
The University of Queensland
CollaboratorOTHER
Ministry of Health, Italy
CollaboratorOTHER_GOV
IRCCS Fondazione Stella Maris
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Years to 25 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* movement disorders * sensory deficits

Design outcomes

Primary

MeasureTime frameDescription
Correlation between Asymmetry Index (AI) and Assisting Hand Assessment (AHA) scores.BaselineThe asymmetry index (AI) is the difference between the mean activities of the dominant with those of the non dominant hand and it will be correlated with the scores of AHA. The AHA measures Upper Limb function during bimanual activities. The test evaluates spontaneous use of assisting hand during a semi-structured 10-15 minutes session with specific toys (Kids-AHA) or tasks (Ad-AHA) requiring bimanual handling.

Secondary

MeasureTime frameDescription
Correlation between AI during AHA and AI in 7 daysBaseline- 1 weekCorrelation of AI between a standardized bimanual test with 7 days of common daily life

Other

MeasureTime frameDescription
Correlation between Box and Block test (BBT) and mean activity of dominant and non dominant handBaselineThe mean activity of each hand will be correlated with the BBT that measures unilateral gross manual dexterity. It is a quick (2-5 minutes), simple and inexpensive test. It can be used with a wide range of populations from childhood to adulthood.
Correlation among Mean activity and asymmetry index during standardized clinical activities.BaselineThe mean activity of each hand and the asymmetry index will be analyzed during some other activities such as Writing, Upper Limb Physician's Rating Scale, Six Minutes Walking Test, Rest Supine Position

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026