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

Primary Purpose

Spinal Muscular Atrophy, Assessment, Self

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Motor assessment
Sponsored by
Centre d'Investigation Clinique et Technologique 805
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Spinal Muscular Atrophy focused on measuring Spinal Muscular Atrophy, Children, Motor assessment, Space exploration, Upper limbs

Eligibility Criteria

3 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital Raymond Poincare
  • Nicolas ROCHE, Md PhD

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Evaluation

Arm Description

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.

Outcomes

Primary Outcome Measures

Motor Function Measure (MFM)
Clinical Evaluation

Secondary Outcome Measures

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

Full Information

First Posted
July 18, 2017
Last Updated
November 22, 2019
Sponsor
Centre d'Investigation Clinique et Technologique 805
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1. Study Identification

Unique Protocol Identification Number
NCT03223051
Brief Title
Development of a Space Exploration Assessment for Children With Spinal Muscular Atrophy
Acronym
ExplorASI
Official Title
Development of a Space Exploration Assessment for Children With Spinal Muscular Atrophy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
September 7, 2017 (Actual)
Primary Completion Date
November 22, 2019 (Actual)
Study Completion Date
November 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre d'Investigation Clinique et Technologique 805

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Muscular Atrophy, Assessment, Self
Keywords
Spinal Muscular Atrophy, Children, Motor assessment, Space exploration, Upper limbs

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Evaluation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Motor assessment
Intervention Description
An occupational therapist install the patient sitting in front of the test board and tell him the instructions
Primary Outcome Measure Information:
Title
Motor Function Measure (MFM)
Description
Clinical Evaluation
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Space Exploration Test (SET)
Description
The SET is made through a test board 170 cm long and 60 cm deep, developed by in our lab
Time Frame
20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas ROCHE, MDphD
Organizational Affiliation
Raymond Poincare HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Raymond Poincare
City
Garches
ZIP/Postal Code
92380
Country
France
Facility Name
Nicolas ROCHE, Md PhD
City
Garches
ZIP/Postal Code
92380
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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