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

This study is not yet open for participant recruitment.
Verified July 2017 by Centre d'Investigation Clinique et Technologique 805
Sponsor:
ClinicalTrials.gov Identifier:
NCT03223051
First Posted: July 19, 2017
Last Update Posted: July 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre d'Investigation Clinique et Technologique 805
  Purpose
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.

Condition Intervention
Spinal Muscular Atrophy Assessment, Self Other: Motor assessment

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Development of a Space Exploration Assessment for Children With Spinal Muscular Atrophy

Resource links provided by NLM:


Further study details as provided by Centre d'Investigation Clinique et Technologique 805:

Primary Outcome Measures:
  • Motor Function Measure (MFM) [ Time Frame: 1 hour ]
    Clinical Evaluation


Secondary Outcome Measures:
  • Tiredness [ Time Frame: 1 minute ]
    Visual analog scale

  • Motivation [ Time Frame: 1 minute ]
    Visual analog scale

  • Satisfaction [ Time Frame: 1 minute ]
    Visual analog scale


Estimated Enrollment: 30
Anticipated Study Start Date: July 2017
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03223051


Contacts
Contact: Nicolas ROCHE, MDphD 0033147105409 roche.nicolas@aphp.fr

Sponsors and Collaborators
Centre d'Investigation Clinique et Technologique 805
Investigators
Principal Investigator: Nicolas ROCHE, MDphD Raymond Poincare HOSPITAL
  More Information

Responsible Party: Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier: NCT03223051     History of Changes
Other Study ID Numbers: 2017-A01017-46
First Submitted: July 18, 2017
First Posted: July 19, 2017
Last Update Posted: July 19, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre d'Investigation Clinique et Technologique 805:
Spinal Muscular Atrophy
Children
Motor assessment
Space exploration
Upper limbs

Additional relevant MeSH terms:
Atrophy
Muscular Atrophy
Muscular Atrophy, Spinal
Pathological Conditions, Anatomical
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Spinal Cord Diseases
Central Nervous System Diseases
Motor Neuron Disease
Neurodegenerative Diseases
Neuromuscular Diseases