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Comparison of Gait Parameters Between Floor and Sponge Surfaces and Special Shoes

Primary Purpose

Arthroscopic Knee Surgery, Lower Limb Fractures, Back Pain and Asymmetric Gait

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Soft surface
Floor
Kyboot shoes
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Arthroscopic Knee Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 3 days to 1 month following arthroscopic knee surgery(n=10)
  • Following fractures in lower limb with pain during weight-bearing (n=10)
  • Back pain and asymmetrical gait (n=10)
  • Complex Regional Pain Syndrome with pain during weight-bearing (n=10)

Exclusion Criteria:

  • Neurological condition that does not permit walking on soft surface (drop foot)
  • Wounds on feet

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Other

    Other

    Other

    Arm Label

    Soft surface

    Floor

    Shoes

    Arm Description

    A soft sponge used for physiotherapy is placed on the floor along a path,

    The subject will walk on the floor.

    Special shoes (Kyboot) with air cushions that are meant to relieve pressure will be used.

    Outcomes

    Primary Outcome Measures

    Gait velocity
    velocity [m/s]

    Secondary Outcome Measures

    Step length
    Step length [cm]
    Base width
    Base width [cm]
    Cadence
    Cadence [steps/s]
    Single limb support duration
    Single limb support time [s and % gait cycle time]
    Double limb support duration
    Double limb support time [s and % gait cycle time]

    Full Information

    First Posted
    March 2, 2016
    Last Updated
    February 12, 2017
    Sponsor
    Hadassah Medical Organization
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02742376
    Brief Title
    Comparison of Gait Parameters Between Floor and Sponge Surfaces and Special Shoes
    Official Title
    Comparison of Gait Parameters Between Floor and Sponge Surfaces and Special Shoes in Individuals With Difficulties in Weight-bearing
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2017 (Anticipated)
    Primary Completion Date
    April 2018 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hadassah Medical Organization

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study compares the gait pattern of individuals with weight bearing difficulties walking on the floor, a soft surface, or with special shoes (Kyboot).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Arthroscopic Knee Surgery, Lower Limb Fractures, Back Pain and Asymmetric Gait, Complex Regional Pain Syndrome

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Soft surface
    Arm Type
    Other
    Arm Description
    A soft sponge used for physiotherapy is placed on the floor along a path,
    Arm Title
    Floor
    Arm Type
    Other
    Arm Description
    The subject will walk on the floor.
    Arm Title
    Shoes
    Arm Type
    Other
    Arm Description
    Special shoes (Kyboot) with air cushions that are meant to relieve pressure will be used.
    Intervention Type
    Other
    Intervention Name(s)
    Soft surface
    Intervention Description
    A sponge rectangle used in physiotherapy will be placed on the floor,
    Intervention Type
    Other
    Intervention Name(s)
    Floor
    Intervention Description
    A marked path on the floor where the subject is instructed to walk.
    Intervention Type
    Other
    Intervention Name(s)
    Kyboot shoes
    Intervention Description
    Special shoes will be worn by the subject.
    Primary Outcome Measure Information:
    Title
    Gait velocity
    Description
    velocity [m/s]
    Time Frame
    Two hours
    Secondary Outcome Measure Information:
    Title
    Step length
    Description
    Step length [cm]
    Time Frame
    Two hours
    Title
    Base width
    Description
    Base width [cm]
    Time Frame
    Two hours
    Title
    Cadence
    Description
    Cadence [steps/s]
    Time Frame
    Two hours
    Title
    Single limb support duration
    Description
    Single limb support time [s and % gait cycle time]
    Time Frame
    Two hours
    Title
    Double limb support duration
    Description
    Double limb support time [s and % gait cycle time]
    Time Frame
    Two hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 3 days to 1 month following arthroscopic knee surgery(n=10) Following fractures in lower limb with pain during weight-bearing (n=10) Back pain and asymmetrical gait (n=10) Complex Regional Pain Syndrome with pain during weight-bearing (n=10) Exclusion Criteria: Neurological condition that does not permit walking on soft surface (drop foot) Wounds on feet
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Isabella Schwartz, MD
    Phone
    02-5844474
    Email
    isabellas@hadassah.org.il
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hadas Lemberg, PhD
    Phone
    00 972 2 6777572
    Email
    lhadas@hadassah.org.il

    12. IPD Sharing Statement

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    Comparison of Gait Parameters Between Floor and Sponge Surfaces and Special Shoes

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