Actigraphs for Detection of Asymmetries

Completed

• Conditions: Hemiplegic Cerebral Palsy; Hemiplegia
• Interventions: Other: Actigraph

• Registration Number: NCT03054441
• Lead Sponsor: IRCCS Fondazione Stella Maris

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.

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-02-11
• Study First Submitted QC: 2017-02-11
• Study First Posted: 2017-02-15
• Primary Completion: 2018-07
• Status Verified: 2018-09
• Study Completion: 2018-09
• Last Update Submitted: 2018-09-13
• Last Update Posted: 2018-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

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

Exclusion Criteria

• movement disorders
• sensory deficits

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental group	Actigraph	Children, Adolescents and Young with hemiplegia
Control group	Actigraph	Children, Adolescents and Young with typical development

Primary Outcome Measures

Name	Time	Method
Correlation between Asymmetry Index (AI) and Assisting Hand Assessment (AHA) scores.	Baseline	The 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 Outcome Measures

Name	Time	Method
Correlation between AI during AHA and AI in 7 days	Baseline- 1 week	Correlation of AI between a standardized bimanual test with 7 days of common daily life

Trial Locations

Locations (1)

IRCCS Stella Maris Foundation; 🇮🇹 Calambrone, Pisa, Italy