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
|Condition or disease||Intervention/treatment|
|Hemiplegia Hemiplegic Cerebral Palsy||Other: Actigraph|
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 [Patient Registry]|
|Actual Enrollment :||106 participants|
|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|
Children, Adolescents and Young with hemiplegia
Actigraphs worn on wrists
Children, Adolescents and Young with typical development
Actigraphs worn on wrists
- 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.
- 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
- 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.
- 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
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
|IRCCS Stella Maris Foundation|
|Calambrone, Pisa, Italy, 56128|
|Principal Investigator:||Giuseppina Sgandurra, MD, PhD||IRCCS Fondazione Stella Maris|