NCT01638169

Brief Summary

During the stand phase the DMD foot is too plantarflexed in addition patients adopt a higher flexion and abduction of the hip in order to advance the swinging limb. The aim of this work is to assess the immediate contribution of heels for these walking disturbance in children with muscular dystrophy disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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 9, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 11, 2012

Completed
10 months until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 8, 2016

Status Verified

June 1, 2015

Enrollment Period

7 months

First QC Date

July 9, 2012

Last Update Submit

April 7, 2016

Conditions

Step Time and LengthSymmetryStep Time and Length VariabilityHeart RateGait Velocity

Outcome Measures

Primary Outcomes (1)

  • gait parameters

    pre and post heels adj.

Study Arms (1)

20 children with DMD

Device: adding a heel

Interventions

adding a heelDEVICE

walking with and without heels on the gaitrite system

20 children with DMD

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

children with DMD age \>6 yrs walk without heel strike

You may qualify if:

  • age \>6 yrs
  • walk without heel strike

You may not qualify if:

  • cannot understand simple instructions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alyn

Jerusalem, 90190, Israel

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2012

First Posted

July 11, 2012

Study Start

May 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

April 8, 2016

Record last verified: 2015-06

Locations

IL(1)