Step Time and LengthNCT01638169
The Contribution of Heels for Walking Quality Among Children With Muscular Dystrophy
An observational study of Step Time and Length and Symmetry, run by Alyn Pediatric & Adolescent Rehabilitation Hospital at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Step Time and Length, Symmetry, Step Time and Length Variability
- What is being tested?
- adding a heel
- Type of treatment
- Medical device
- How many people
- 11 participants
- Where
- 1 siteIsrael
- Study dates
- May 2013to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: children with DMD age >6 yrs walk without heel strike
Who may be able to join
- age >6 yrs
- walk without heel strike
Who cannot join
- cannot understand simple instructions
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Step Time and Length, Symmetry, Step Time and Length Variability, Heart Rate, Gait Velocity
- Being tested
- adding a heel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adding a heelDevice
walking with and without heels on the gaitrite system
| Study group | Role | What they receive |
|---|---|---|
| 20 children with DMD | Not described Receives: Device: adding a heel |
What is being measured
The primary outcome is the main question the study is designed to answer.
gait parameters
Measured: pre and post heels adj.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startMay 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Step Time and LengthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alyn Pediatric & Adolescent Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01638169
- Sponsor's protocol ID
- 920100239
- Status last verified
- Jun 2015
- First submitted
- 9 Jul 2012
- Last updated
- 8 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Contribution of Heels for Walking Quality Among Children With Muscular Dystrophy
- ClinicalTrials.gov ID
- NCT01638169
- Acronym / sponsor ID
- 920100239
- Conditions
- Step Time and Length, Symmetry, Step Time and Length Variability, Heart Rate, Gait Velocity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Alyn Pediatric & Adolescent Rehabilitation HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 20 children with DMD | – | Device: adding a heel |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children with DMD age >6 yrs walk without heel strike
Key inclusion criteria (2 listed)
- age >6 yrs
- walk without heel strike
Key exclusion criteria (1 listed)
- cannot understand simple instructions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adding a heelwalking with and without heels on the gaitrite system | Device | 20 children with DMD |
Primary outcome
gait parameters
Time frame: pre and post heels adj.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2016.
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Recruiting
Effects of Treadmill-Based Gait Training in Patients With Stroke
Gait, Thermography
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Step Time and Length and Symmetry, run by Alyn Pediatric & Adolescent Rehabilitation Hospital at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gait parameters (time frame: pre and post heels adj.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2016.