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

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ClinicalTrials.gov Identifier: NCT03223051
Recruitment Status : Recruiting
First Posted : July 19, 2017
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Centre d'Investigation Clinique et Technologique 805

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.

Condition or disease Intervention/treatment Phase
Spinal Muscular Atrophy Assessment, Self Other: Motor assessment Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Actual Study Start Date : September 7, 2017
Actual Primary Completion Date : September 7, 2017
Estimated Study Completion Date : September 2020


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




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


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

  2. Motivation [ Time Frame: 1 minute ]
    Visual analog scale

  3. Satisfaction [ Time Frame: 1 minute ]
    Visual analog scale



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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

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

Locations
France
Hopital Raymond Poincare Recruiting
Garches, France, 92380
Contact: ROCHE Nicolas, MDPHD    0147107900    roche.nicolas@rpc.aphp.fr   
Contact: POTTIER Sandra, CRA    0147104469    sandra.pottier@rpc.aphp.fr   
Hopital Raymond Poincare Recruiting
Garches, France, 92380
Contact: Nicolas ROCHE, MDPHD    (33)147105409    roche.nicolas@rpc.aphp.fr   
Contact: Sandra POTTIER, CRA    (33)147104469    sandra.pottier@rpc.aphp.fr   
Nicolas ROCHE, Md PhD Recruiting
Garches, France, 92380
Contact: Nicolas Roche, Md, PhD    0033147105409    roche.nicolas@aphp.fr   
Sponsors and Collaborators
Centre d'Investigation Clinique et Technologique 805
Investigators
Principal Investigator: Nicolas ROCHE, MDphD Raymond Poincare HOSPITAL

Responsible Party: Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier: NCT03223051     History of Changes
Other Study ID Numbers: 2017-A01017-46
First Posted: July 19, 2017    Key Record Dates
Last Update Posted: January 25, 2018
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