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Actigraphs for Detection of Asymmetries

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ClinicalTrials.gov Identifier: NCT03054441
Recruitment Status : Completed
First Posted : February 15, 2017
Last Update Posted : September 14, 2018
Sponsor:
Collaborators:
Scuola Superiore Sant'Anna di Pisa
The University of Queensland
Ministry of Health, Italy
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment
Hemiplegia Hemiplegic Cerebral Palsy Other: Actigraph

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 106 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 7 Days
Official Title: Detection of Asymmetries in Upper Limb Use Through Actigraphs
Actual Study Start Date : January 2017
Actual Primary Completion Date : July 2018
Actual Study Completion Date : September 2018

Group/Cohort Intervention/treatment
Experimental group
Children, Adolescents and Young with hemiplegia
Other: Actigraph
Actigraphs worn on wrists

Control group
Children, Adolescents and Young with typical development
Other: Actigraph
Actigraphs worn on wrists




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   3 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Children, Adolescents and Adults with hemiplegia and age-matched controls with typical development
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • movement disorders
  • sensory deficits

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03054441


Locations
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Italy
IRCCS Stella Maris Foundation
Calambrone, Pisa, Italy, 56128
Sponsors and Collaborators
IRCCS Fondazione Stella Maris
Scuola Superiore Sant'Anna di Pisa
The University of Queensland
Ministry of Health, Italy
Investigators
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Principal Investigator: Giuseppina Sgandurra, MD, PhD IRCCS Fondazione Stella Maris
Additional Information:

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: IRCCS Fondazione Stella Maris
ClinicalTrials.gov Identifier: NCT03054441    
Other Study ID Numbers: GR-2011-02350053
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by IRCCS Fondazione Stella Maris:
Upper limb
Inertial sensors
Additional relevant MeSH terms:
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Cerebral Palsy
Hemiplegia
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Paralysis
Neurologic Manifestations