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

NCT ID: NCT03223051

Last Updated: 2019-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-07

Study Completion Date

2019-11-22

Brief Summary

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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

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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.

Conditions

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Spinal Muscular Atrophy Assessment, Self

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Motor assessment

Intervention Type OTHER

An occupational therapist install the patient sitting in front of the test board and tell him the instructions

Interventions

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Motor assessment

An occupational therapist install the patient sitting in front of the test board and tell him the instructions

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre d'Investigation Clinique et Technologique 805

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicolas ROCHE, MDphD

Role: PRINCIPAL_INVESTIGATOR

Raymond Poincare HOSPITAL

Locations

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Hopital Raymond Poincare

Garches, , France

Site Status

Nicolas ROCHE, Md PhD

Garches, , France

Site Status

Countries

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France

Other Identifiers

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2017-A01017-46

Identifier Type: -

Identifier Source: org_study_id

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