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NCT03223051 Clinical Trial

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

Spinal Muscular Atrophy Clinical Trial

— ExplorASI  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03223051
Other study ID # 2017-A01017-46
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 7, 2017
Est. completion date November 22, 2019

Study information
Verified date November 2019
Source Centre d'Investigation Clinique et Technologique 805
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date November 22, 2019
Est. primary completion date November 22, 2019
Accepts healthy volunteers No
Gender All
Age group 3 Years to 16 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France Hopital Raymond Poincare Garches
France Nicolas ROCHE, Md PhD Garches

Sponsors (1)
Lead Sponsor Collaborator
Centre d'Investigation Clinique et Technologique 805

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Motor Function Measure (MFM) Clinical Evaluation 1 hour
Secondary Space Exploration Test (SET) The SET is made through a test board 170 cm long and 60 cm deep, developed by in our lab 20 minutes
See also
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