Actigraphs for Detection of Asymmetries

Hemiplegia Clinical Trial

Official title:

Detection of Asymmetries in Upper Limb Use Through Actigraphs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03054441
• Other study ID #: GR-2011-02350053
• Status: Completed
• Start date: January 2017
• Est. completion date: September 2018

Study information

• Verified date: September 2018
• Source: IRCCS Fondazione Stella Maris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: September 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 25 Years

Eligibility

Inclusion Criteria:

• Age between 3-25 years

• Hemiplegia (experimental group) or Voluntary adhesion (control group)

Exclusion Criteria:

• movement disorders

• sensory deficits

Related Conditions & MeSH terms

• Cerebral Palsy
• Hemiplegia
• Hemiplegic Cerebral Palsy

Intervention

Other:
• Actigraph
Actigraphs worn on wrists

Locations

Country	Name	City	State
Italy	IRCCS Stella Maris Foundation	Calambrone	Pisa

Sponsors (4)

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

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Martin JL, Hakim AD. Wrist actigraphy. Chest. 2011 Jun;139(6):1514-1527. doi: 10.1378/chest.10-1872. Review. — View Citation

Nagels G, Mariön P, Pickut BA, Timmermans L, De Deyn PP. Actigraphic evaluation of handedness. Electroencephalogr Clin Neurophysiol. 1996 Jun;101(3):226-32. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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