Back to resultsComparison 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
About this trial
This is an interventional basic science trial for Arthroscopic Knee Surgery
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
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
NCT ID
NCT02742376
First Posted
March 2, 2016
Last Updated
February 12, 2017
Sponsor
Hadassah Medical Organization
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
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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
Learn more about this trial
Comparison of Gait Parameters Between Floor and Sponge Surfaces and Special Shoes
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