Spinal Muscular AtrophyExplorASINCT03223051
Development of a Space Exploration Assessment for Children With Spinal Muscular Atrophy
A study testing Motor assessment in people with Spinal Muscular Atrophy and Assessment, Self, run by Centre d'Investigation Clinique et Technologique 805 at 2 sites in France.
Trial summary
The aim of this randomized study is to develop a new motor assessment of space exploration in a 2D environment with upper limbs for children with spinal muscular atrophy 1 and 2 from 3 until 16 years old. Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Spinal Muscular Atrophy, Assessment, Self
- What is being tested?
- Motor assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesFrance
- Study dates
- 7 Sep 2017to 22 Nov 2019
- Phase
- Interventional
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children, girls and boys, from 3 to 16 years old,
- with Spinal Motor Atrophy 1 and 2
- with social protection
Who cannot join
- cognitive disorders preventing understanding
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hopital Raymond Poincare
Garches, 92380
Nicolas ROCHE, Md PhD
Garches, 92380
About this study
The aim of this randomized study is to develop a new motor assessment of space exploration in a 2D environment with upper limbs for children with spinal muscular atrophy 1 and 2 from 3 until 16 years old.
Read the detailed description
Thirty children are included in the prospective randomized study. They are evaluated with the new test, Space Exploration Test (TES), and with the Motor Function Measure (MFM), a gold standard scale. The objective is to compare the results and to demonstrate the complementarity of the two tools.
- Conditions
- Spinal Muscular Atrophy, Assessment, Self
- Being tested
- Motor assessment
- Keywords
- Spinal Muscular Atrophy, Children, Motor assessment, Space exploration, Upper limbs
- Medical subject headings
- Muscular Atrophy, Spinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor assessmentOther
An occupational therapist install the patient sitting in front of the test board and tell him the instructions
| Study group | Role | What they receive |
|---|---|---|
| Evaluation | Experimental | Included patients will be invited to participate in 1 session, to be evaluated with the Motor Function Measure and the new test of space exploration, during 2 hours maximum, to compare scores with these 2 tests.
An occupational therapist will be required to install the patient in front of the table and to give the instructions. Receives: Other: Motor assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Function Measure (MFM)
Clinical Evaluation
Measured: 1 hour
Secondary outcomes (1)
Space Exploration Test (SET)
The SET is made through a test board 170 cm long and 60 cm deep, developed by in our lab
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start7 Sep 2017
- Primary completion22 Nov 2019
- Study completion22 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Muscular AtrophyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas ROCHE, MDphD, Principal investigator, Raymond Poincare HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03223051
- Sponsor's protocol ID
- 2017-A01017-46
- Acronym
- ExplorASI
- Status last verified
- Nov 2019
- First submitted
- 18 Jul 2017
- Last updated
- 25 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Space Exploration Assessment for Children With Spinal Muscular Atrophy
- ClinicalTrials.gov ID
- NCT03223051
- Acronym / sponsor ID
- ExplorASI / 2017-A01017-46
- Conditions
- Spinal Muscular Atrophy, Assessment, Self
- Keywords
- Spinal Muscular Atrophy, Children, Motor assessment, Space exploration, Upper limbs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Study start
- 7 Sep 2017 (actual)
- Primary completion
- 22 Nov 2019 (actual)
- Study completion
- 22 Nov 2019 (actual)
- First posted
- 19 Jul 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.
The aim of this randomized study is to develop a new motor assessment of space exploration in a 2D environment with upper limbs for children with spinal muscular atrophy 1 and 2 from 3 until 16 years old.
Detailed description
Thirty children are included in the prospective randomized study. They are evaluated with the new test, Space Exploration Test (TES), and with the Motor Function Measure (MFM), a gold standard scale. The objective is to compare the results and to demonstrate the complementarity of the two tools.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation | Experimental | Other: Motor assessmentIncluded patients will be invited to participate in 1 session, to be evaluated with the Motor Function Measure and the new test of space exploration, during 2 hours maximum, to compare scores with these 2 tests. An occupational therapist will be required to install the patient in front of the table and to give the instructions. |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children, girls and boys, from 3 to 16 years old,
- with Spinal Motor Atrophy 1 and 2
- with social protection
Key exclusion criteria (1 listed)
- cognitive disorders preventing understanding
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 |
|---|---|---|
| Motor assessmentAn occupational therapist install the patient sitting in front of the test board and tell him the instructions | Other | Evaluation |
Primary outcome
Motor Function Measure (MFM)
Time frame: 1 hour
Clinical Evaluation
1 secondary outcome
Space Exploration Test (SET)
Time frame: 20 minutes
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 25 Nov 2019.
- Individual participant dataSharing planned: No
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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.
Nicolas ROCHE, MDphD principal investigator
Raymond Poincare HOSPITAL
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor assessment in people with Spinal Muscular Atrophy and Assessment, Self, run by Centre d'Investigation Clinique et Technologique 805 at 2 sites in France.
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 3 inclusion and 1 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 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Motor Function Measure (MFM) (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2019.