HemiplegiaNCT03054441
Actigraphs for Detection of Asymmetries
An observational study of Hemiplegia and Hemiplegic Cerebral Palsy, run by IRCCS Fondazione Stella Maris at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 3 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemiplegia, Hemiplegic Cerebral Palsy
- What is being tested?
- Actigraph
- How many people
- 106 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2017to Sep 2018
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children, Adolescents and Adults with hemiplegia and age-matched controls with typical development
Who may be able to join
- Age between 3-25 years
- Hemiplegia (experimental group) or Voluntary adhesion (control group)
Who cannot join
- movement disorders
- sensory deficits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Hemiplegia, Hemiplegic Cerebral Palsy
- Being tested
- Actigraph
- Keywords
- Upper limb, Inertial sensors
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActigraphOther
Actigraphs worn on wrists
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Children, Adolescents and Young with hemiplegia Receives: Other: Actigraph | |
| Control group | Children, Adolescents and Young with typical development Receives: Other: Actigraph |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (1)
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
Measured: Baseline- 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study startJan 2017
- Primary completionJul 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HemiplegiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- IRCCS Fondazione Stella Maris
- Sponsor type
- University, hospital or other
- Collaborators
- Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna, The University of Queensland, Ministry of Health, Italy
- Responsible party
- Sponsor
- Investigators
- Giuseppina Sgandurra, MD, PhD, Principal investigator, IRCCS Fondazione Stella Maris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03054441
- Sponsor's protocol ID
- GR-2011-02350053
- Status last verified
- Sep 2018
- First submitted
- 11 Feb 2017
- Last updated
- 14 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Martin JL, Hakim AD. Wrist actigraphy. Chest. 2011 Jun;139(6):1514-1527. doi: 10.1378/chest.10-1872.
PubMed 21652563Nagels 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.
PubMed 8647035Beani 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.
PubMed 40181251Beani 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.
PubMed 30795810
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Asymmetries in Upper Limb Use Through Actigraphs
- ClinicalTrials.gov ID
- NCT03054441
- Acronym / sponsor ID
- GR-2011-02350053
- Conditions
- Hemiplegia, Hemiplegic Cerebral Palsy
- Keywords
- Upper limb, Inertial sensors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- IRCCS Fondazione Stella MarisUniversity, hospital or other
- Collaborators
- Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna, The University of Queensland, Ministry of Health, Italy
- Study start
- Jan 2017 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 15 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Other: ActigraphChildren, Adolescents and Young with hemiplegia |
| Control group | – | Other: ActigraphChildren, Adolescents and Young with typical development |
Who may qualify
- Ages
- 3 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children, Adolescents and Adults with hemiplegia and age-matched controls with typical development
Key inclusion criteria (2 listed)
- Age between 3-25 years
- Hemiplegia (experimental group) or Voluntary adhesion (control group)
Key exclusion criteria (2 listed)
- movement disorders
- sensory deficits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ActigraphActigraphs worn on wrists | Other | Control group, Experimental group |
Primary outcome
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.
1 secondary outcome
Correlation between AI during AHA and AI in 7 days
Time frame: Baseline- 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2018.
- Background: PubMed 21652563Martin JL, Hakim AD. Wrist actigraphy. Chest. 2011 Jun;139(6):1514-1527. doi: 10.1378/chest.10-1872.
- Background: PubMed 8647035Nagels 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.
- Derived from this study: PubMed 40181251Beani 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.
- Derived from this study: PubMed 30795810Beani 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.
- Individual participant dataSharing planned: No
Related trials for Hemiplegia
Not yet recruiting
Effects of Upper Extremity Physiotherapy and Home Exercises on Functional Outcomes in Individuals With Stroke
Stroke
Recruiting
Task-Oriented Training Versus High-Intensity Gait Training in People With Chronic Stroke
Stroke, Hemiplegia
Active, not recruitingObservational study
Studies of the Variable Phenotypic Presentations of Rapid-Onset Dystonia Parkinsonism and Other Movement Disorders
Dystonia, Parkinsonism
RecruitingObservational study
Post-Stroke Apraxia, Motor Function, Balance, and Gait
Stroke, Ideomotor Apraxia
RecruitingObservational study
Ideomotor Apraxia and Robotic Gait Rehabilitation Outcomes After Stroke
Stroke, Ideomotor Apraxia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppina Sgandurra, MD, PhD principal investigator
IRCCS Fondazione Stella Maris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemiplegia and Hemiplegic Cerebral Palsy, run by IRCCS Fondazione Stella Maris at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between Asymmetry Index (AI) and Assisting Hand Assessment (AHA) scores. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03054441, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2018.