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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Muscular Atrophy; Assessment, Self
• Intervention / Treatment: Other: Motor assessment

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Garches, France, 92380
    • Hôpital Raymond Poincaré
  • Garches, France, 92380
    • Nicolas ROCHE, Md PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Evaluation; 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.	Other: Motor assessment; An occupational therapist install the patient sitting in front of the test board and tell him the instructions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor Function Measure (MFM)	Clinical Evaluation	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre d'Investigation Clinique et Technologique 805
• Investigators: Principal Investigator: Nicolas ROCHE, MDphD, Raymond Poincaré Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2017
• Primary Completion (Actual): November 22, 2019
• Study Completion (Actual): November 22, 2019

Study Registration Dates

• First Submitted: July 18, 2017
• First Submitted That Met QC Criteria: July 18, 2017
• First Posted (Actual): July 19, 2017

Study Record Updates

• Last Update Posted (Actual): November 25, 2019
• Last Update Submitted That Met QC Criteria: November 22, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Children; Spinal Muscular Atrophy; Upper limbs; Motor assessment; Space exploration
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neuromuscular Diseases; Neurodegenerative Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Spinal Cord Diseases; Motor Neuron Disease; Muscular Atrophy; Atrophy; Muscular Atrophy, Spinal
• Other Study ID Numbers: 2017-A01017-46

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No