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OpenTrials
Completed

NCT Number: NCT03223051

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

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.

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Key information

Conditions

Spinal Muscular Atrophy Assessment, Self Central Nervous System Diseases Motor Neuron Disease Muscular Atrophy, Spinal Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Spinal Cord Diseases

Age range

3 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Raymond Poincare, Garches, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motor assessment

Other

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

Primary outcomes

  1. Motor Function Measure (MFM)

    Time frame: 1 hour

    Clinical Evaluation

Secondary outcomes

  1. Space Exploration Test (SET)

    Time frame: 20 minutes

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

Sponsors and collaborators

Lead sponsor

Centre d'Investigation Clinique et Technologique 805

Other

Registry information

Acronym: ExplorASI

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 19, 2017
Registry last updated
Nov 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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