Actigraphs for Detection of Asymmetries

Detection of Asymmetries in Upper Limb Use Through Actigraphs

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).

Study Overview

• Status: Completed
• Conditions: Hemiplegia; Hemiplegic Cerebral Palsy
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 106

Contacts and Locations

Study Locations

• Italy
  • Pisa
    • Calambrone, Pisa, Italy, 56128
      • IRCCS Stella Maris Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 25 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Children, Adolescents and Adults with hemiplegia and age-matched controls with typical development

Description

Inclusion Criteria:

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

Exclusion Criteria:

• movement disorders
• sensory deficits

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between Asymmetry Index (AI) and Assisting Hand Assessment (AHA) scores.	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.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between AI during AHA and AI in 7 days	Correlation of AI between a standardized bimanual test with 7 days of common daily life	Baseline- 1 week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between Box and Block test (BBT) and mean activity of dominant and non dominant hand	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.	Baseline
Correlation among Mean activity and asymmetry index during standardized clinical activities.	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	Baseline

Collaborators and Investigators

• Sponsor: IRCCS Fondazione Stella Maris
• Collaborators: Ministry of Health, Italy; The University of Queensland; Scuola Superiore Sant'Anna di Pisa
• Investigators: Principal Investigator: Giuseppina Sgandurra, MD, PhD, IRCCS Fondazione Stella Maris

Publications and helpful links

General Publications

• Martin JL, Hakim AD. Wrist actigraphy. Chest. 2011 Jun;139(6):1514-1527. doi: 10.1378/chest.10-1872.
• Nagels G, Marion P, Pickut BA, Timmermans L, De Deyn PP. Actigraphic evaluation of handedness. Electroencephalogr Clin Neurophysiol. 1996 Jun;101(3):226-32. doi: 10.1016/0924-980x(96)95566-6.
• Beani E, Maselli M, Sicola E, Perazza S, Cecchi F, Dario P, Braito I, Boyd R, Cioni G, Sgandurra G. Actigraph assessment for measuring upper limb activity in unilateral cerebral palsy. J Neuroeng Rehabil. 2019 Feb 22;16(1):30. doi: 10.1186/s12984-019-0499-7.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ACTUAL): July 1, 2018
• Study Completion (ACTUAL): September 1, 2018

Study Registration Dates

• First Submitted: February 11, 2017
• First Submitted That Met QC Criteria: February 11, 2017
• First Posted (ACTUAL): February 15, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 14, 2018
• Last Update Submitted That Met QC Criteria: September 13, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Upper limb; Inertial sensors
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Paralysis; Cerebral Palsy; Hemiplegia
• Other Study ID Numbers: GR-2011-02350053

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No