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Completed

NCT Number: NCT03054441

Actigraphs for Detection of Asymmetries

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).

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Key information

Conditions

Hemiplegia Hemiplegic Cerebral Palsy Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

3 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Stella Maris Foundation

Calambrone, Pisa, 56128, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • movement disorders
  • sensory deficits

Treatment and study plan

Actigraph

Other

Actigraphs worn on wrists

Primary outcomes

  1. Correlation between Asymmetry Index (AI) and Assisting Hand Assessment (AHA) scores.

    Time frame: 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 outcomes

  1. Correlation between AI during AHA and AI in 7 days

    Time frame: Baseline- 1 week

    Correlation of AI between a standardized bimanual test with 7 days of common daily life

Other outcomes

  1. Correlation between Box and Block test (BBT) and mean activity of dominant and non dominant hand

    Time frame: Baseline

    The 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.

  2. Correlation among Mean activity and asymmetry index during standardized clinical activities.

    Time frame: Baseline

    The 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

Sponsors and collaborators

Lead sponsor

IRCCS Fondazione Stella Maris

Other

Collaborators

  • Ministry of Health, Italy
  • Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
  • The University of Queensland

Registry information

Official study title

Detection of Asymmetries in Upper Limb Use Through Actigraphs

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 15, 2017
Registry last updated
Sep 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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