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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Assessment, Self
• Atrophy
• Muscular Atrophy
• Muscular Atrophy, Spinal
• Spinal Muscular Atrophy

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