Development of a Space Exploration Assessment for Children With Spinal Muscular Atrophy

NCT03223051 — Not applicable, Completed, 30 participants, Centre d'Investigation Clinique et Technologique 805

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Registry	NCT03223051, acronym ExplorASI
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, other
Enrollment	30 (Actual)
Sponsor	Centre d'Investigation Clinique et Technologique 805 (Other)
Conditions	Spinal Muscular Atrophy, Assessment, Self
Interventions	Motor assessment (Other)
Dates	start 2017-09-07, primary completion 2019-11-22, completion 2019-11-22, first posted 2017-07-19, last updated 2019-11-25
Locations	2 sites in France

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Evaluation	Experimental	Other: Motor assessment	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.

Motor assessment (Other): An occupational therapist install the patient sitting in front of the test board and tell him the instructions

+Outcome measures

Primary outcomes

Motor Function Measure (MFM) [1 hour]: Clinical Evaluation

Secondary outcomes

Space Exploration Test (SET) [20 minutes]: The SET is made through a test board 170 cm long and 60 cm deep, developed by in our lab

+Eligibility

Sex: All, ages: 3 Years to 16 Years

Inclusion Criteria:

* children, girls and boys, from 3 to 16 years old,
* with Spinal Motor Atrophy 1 and 2
* with social protection

Exclusion Criteria:

* cognitive disorders preventing understanding

+Locations (2)

Facility	City	Country	Status
Hopital Raymond Poincare	Garches	France
Nicolas ROCHE, Md PhD	Garches	France

+Investigators

Nicolas ROCHE, MDphD, Principal investigator, Raymond Poincare HOSPITAL