NCT02947906

Brief 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. Plantar pressure distribution parameters will assess with dynamic pedobarography.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2016

Shorter than P25 for all trials

Status
unknown

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

Study Start

First participant enrolled

October 1, 2016

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 28, 2016

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

October 28, 2016

Status Verified

October 1, 2016

Enrollment Period

1 month

First QC Date

October 25, 2016

Last Update Submit

October 26, 2016

Conditions

Multiple Sclerosis

Keywords

GaitLoadingMultiple SclerosisPlantar Pressure

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

Study Arms (2)

Study group

Participants with multiple sclerosis who able to walk at least 30 meters independently.

Other: No intervention

Control Group

Healthy participants

Other: No intervention

Interventions

No interventionOTHER

No intervention

Control GroupStudy group

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Participants with multiple sclerosis

You may qualify if:

  • Want to participate Individuals with multiple sclerosis who can walk alone for 30 meters Healthy participants who diagnosed no disorders or orthopedic problems.

You may not qualify if:

  • Want to participate Individuals with multiple sclerosis who can walk alone for 50 meters Healthy participants who diagnosed no disorders or orthopedic problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, PT

Study Record Dates

First Submitted

October 25, 2016

First Posted

October 28, 2016

Study Start

October 1, 2016

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

October 28, 2016

Record last verified: 2016-10