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

• Sponsor: Centre d'Investigation Clinique et Technologique 805 (Other)
• Overall Status: Completed
• CT.gov ID: NCT03223051
• Collaborator: (none)
• Enrollment: 30
• Locations: 2
• Arm: 1
• Actual Duration (Months): 26.5
• Patients Per Site: 15
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Muscular Atrophy; Assessment, Self	Other: Motor assessment	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• 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: Sep 7, 2017
• Actual Primary Completion Date: Nov 22, 2019
• Actual Study Completion Date: Nov 22, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Motor Function Measure (MFM) [1 hour]

   Clinical Evaluation

Secondary Outcome Measures

1. Space Exploration Test (SET) [20 minutes]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 16 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Hopital Raymond Poincare	Garches		France	92380
2	Nicolas ROCHE, Md PhD	Garches		France	92380

Sponsors and Collaborators

• Centre d'Investigation Clinique et Technologique 805

Investigators

• Principal Investigator: Nicolas ROCHE, MDphD, Raymond Poincare HOSPITAL

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre d'Investigation Clinique et Technologique 805
• ClinicalTrials.gov Identifier: NCT03223051
• Other Study ID Numbers: 2017-A01017-46
• First Posted: Jul 19, 2017
• Last Update Posted: Nov 25, 2019
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• 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: Muscular Atrophy; Muscular Atrophy, Spinal; Atrophy

Study Results

No Results Posted as of Nov 25, 2019