Multiple SclerosisNCT02947906
Plantar Pressure Distribution in Patient With Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Hacettepe University.
Trial summary
Fifty patients who were referred to receive physiotherapy and 20 healthy volunteers will be participants of the study.Participants with multiple sclerosis will evaluate with the following assessment tools: Modified Ashworth scale will use to evaluation of severity of plantar flexor spasticity. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Nov 2016
- 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Participants with multiple sclerosis
Who may be able to join
- Want to participate Individuals with multiple sclerosis who can walk alone for 30 meters Healthy participants who diagnosed no disorders or orthopedic problems.
Who cannot join
- Want to participate Individuals with multiple sclerosis who can walk alone for 50 meters Healthy participants who diagnosed no disorders or orthopedic problems.
About this study
Official title: Investigating the Plantar Pressure Distribution in Patient With Multiple Sclerosis
Fifty patients who were referred to receive physiotherapy and 20 healthy volunteers will be participants of the study.Participants with multiple sclerosis will evaluate with the following assessment tools: Modified Ashworth scale will use to evaluation of severity of plantar flexor spasticity. Plantar pressure distribution parameters will assess with dynamic pedobarography.
Read the detailed description
Fifty patients who were referred to receive physiotherapy at the neurology department of Physiotherapy and Rehabilitation of the Faculty of Health Sciences of Hacettepe University, Ankara with multiple sclerosis and twenty voluntary healthy age matched participants will be the subjects of this study.
Assessment tools described as following: Modified Ashworth scale will use to evaluate of severity of plantar flexor spasticity. Static and dynamic loading parameters will be evaluate with pedobarography.Maximum loading pressure -N/cm2, maximum loading time- ms for; 1st. and 5th metatarsal head, medial and lateral heel and midfoot will be recorded both while the patients standing and walking.
- Conditions
- Multiple Sclerosis
- Being tested
- No intervention
- Keywords
- Gait, Loading, Multiple Sclerosis, Plantar Pressure
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Study group | Participants with multiple sclerosis who able to walk at least 30 meters independently. Receives: Other: No intervention | |
| Control Group | Healthy participants Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pedobarography for assessment of foot pressure while standing and walking
Participant stands and walks on system name is pedobarography which records foot pressure. Foot pressure means, gravitational force reflecting from ground at every foot step phase. Newton/cm2 is the unit of measure.
Measured: Initially evaluation at first minute, Change from initial evaluation to 20th minutes, Change from initial evaluation to 24 hours, Change from initial evaluation to 24 hours and 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionNov 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hhotaman, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02947906
- Sponsor's protocol ID
- G0 16/344
- Status last verified
- Oct 2016
- First submitted
- 25 Oct 2016
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Plantar Pressure Distribution in Patient With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02947906
- Acronym / sponsor ID
- G0 16/344
- Conditions
- Multiple Sclerosis
- Keywords
- Gait, Loading, Multiple Sclerosis, Plantar Pressure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 28 Oct 2016 (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.
Fifty patients who were referred to receive physiotherapy and 20 healthy volunteers will be participants of the study.Participants with multiple sclerosis will evaluate with the following assessment tools: Modified Ashworth scale will use to evaluation of severity of plantar flexor spasticity. Plantar pressure distribution parameters will assess with dynamic pedobarography.
Detailed description
Fifty patients who were referred to receive physiotherapy at the neurology department of Physiotherapy and Rehabilitation of the Faculty of Health Sciences of Hacettepe University, Ankara with multiple sclerosis and twenty voluntary healthy age matched participants will be the subjects of this study.
Assessment tools described as following: Modified Ashworth scale will use to evaluate of severity of plantar flexor spasticity. Static and dynamic loading parameters will be evaluate with pedobarography.Maximum loading pressure -N/cm2, maximum loading time- ms for; 1st. and 5th metatarsal head, medial and lateral heel and midfoot will be recorded both while the patients standing and walking.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: No interventionParticipants with multiple sclerosis who able to walk at least 30 meters independently. |
| Control Group | – | Other: No interventionHealthy participants |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants with multiple sclerosis
Key inclusion criteria (1 listed)
- Want to participate Individuals with multiple sclerosis who can walk alone for 30 meters Healthy participants who diagnosed no disorders or orthopedic problems.
Key exclusion criteria (1 listed)
- Want to participate Individuals with multiple sclerosis who can walk alone for 50 meters Healthy participants who diagnosed no disorders or orthopedic problems.
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 |
|---|---|---|
| No interventionNo intervention | Other | Control Group, Study group |
Primary outcome
Pedobarography for assessment of foot pressure while standing and walking
Time frame: Initially evaluation at first minute, Change from initial evaluation to 20th minutes, Change from initial evaluation to 24 hours, Change from initial evaluation to 24 hours and 20 minutes
Participant stands and walks on system name is pedobarography which records foot pressure. Foot pressure means, gravitational force reflecting from ground at every foot step phase. Newton/cm2 is the unit of measure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2016.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Hacettepe University.
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 1 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: status not confirmed, as of the sponsor's last update on 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Pedobarography for assessment of foot pressure while standing and walking (time frame: Initially evaluation at first minute, Change from initial evaluation to 20th minutes, Change from initial evaluation to 24 hours, Change from initial evaluation to 24 hours and 20 minutes). 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 28 Oct 2016; AzTrials last refreshed its copy on 6 Nov 2026.