NCT03054441

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 11, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 15, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

September 14, 2018

Status Verified

September 1, 2018

Enrollment Period

1.5 years

First QC Date

February 11, 2017

Last Update Submit

September 13, 2018

Conditions

HemiplegiaHemiplegic Cerebral Palsy

Keywords

Upper limbInertial sensors

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Correlation between AI during AHA and AI in 7 days

    Baseline- 1 week

Other Outcomes (2)

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

    Baseline

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

    Baseline

Study Arms (2)

Experimental group

Children, Adolescents and Young with hemiplegia

Other: Actigraph

Control group

Children, Adolescents and Young with typical development

Other: Actigraph

Interventions

ActigraphOTHER

Actigraphs worn on wrists

Control groupExperimental group

Eligibility Criteria

Age3 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • movement disorders
  • sensory deficits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Stella Maris Foundation

Calambrone, Pisa, 56128, Italy

Location

Related Publications (4)

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

    PMID: 21652563BACKGROUND

  • 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.

    PMID: 8647035BACKGROUND

  • Beani E, de 'Cavalieri MF, Filogna S, Barzacchi V, Cianchetti M, Maselli M, Martini G, Menici V, Prencipe G, Sicola E, Cioni G, Sgandurra G. Wearable sensors for measuring spontaneous upper limb use in children with unilateral cerebral palsy and typical development. J Neuroeng Rehabil. 2025 Apr 3;22(1):71. doi: 10.1186/s12984-025-01601-3.

    PMID: 40181251DERIVED

  • 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.

    PMID: 30795810DERIVED

MeSH Terms

Conditions

Hemiplegia

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Giuseppina Sgandurra, MD, PhD

    IRCCS Fondazione Stella Maris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2017

First Posted

February 15, 2017

Study Start

January 1, 2017

Primary Completion

July 1, 2018

Study Completion

September 1, 2018

Last Updated

September 14, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)