NCT03223051

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 19, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

September 7, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2019

Completed
Last Updated

November 25, 2019

Status Verified

November 1, 2019

Enrollment Period

2.2 years

First QC Date

July 18, 2017

Last Update Submit

November 22, 2019

Conditions

Spinal Muscular AtrophyAssessment, Self

Keywords

Spinal Muscular AtrophyChildrenMotor assessmentSpace explorationUpper limbs

Outcome Measures

Primary Outcomes (1)

  • Motor Function Measure (MFM)

    Clinical Evaluation

    1 hour

Secondary Outcomes (1)

  • Space Exploration Test (SET)

    20 minutes

Study Arms (1)

Evaluation

EXPERIMENTAL

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

Interventions

Motor assessmentOTHER

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

Evaluation

Eligibility Criteria

Age3 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • children, girls and boys, from 3 to 16 years old,
  • with Spinal Motor Atrophy 1 and 2
  • with social protection

You may not qualify if:

  • cognitive disorders preventing understanding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hopital Raymond Poincare

Garches, 92380, France

Location

Nicolas ROCHE, Md PhD

Garches, 92380, France

Location

MeSH Terms

Conditions

Muscular Atrophy, Spinal

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesNeuromuscular Diseases

Study Officials

  • Nicolas ROCHE, MDphD

    Raymond Poincare HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2017

First Posted

July 19, 2017

Study Start

September 7, 2017

Primary Completion

November 22, 2019

Study Completion

November 22, 2019

Last Updated

November 25, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)