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

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ClinicalTrials.gov Identifier: NCT02742376
Recruitment Status : Unknown
Verified February 2016 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : April 19, 2016
Last Update Posted : February 14, 2017
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization

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).

Condition or disease Intervention/treatment Phase
Arthroscopic Knee Surgery Lower Limb Fractures Back Pain and Asymmetric Gait Complex Regional Pain Syndrome Other: Soft surface Other: Floor Other: Kyboot shoes Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Comparison of Gait Parameters Between Floor and Sponge Surfaces and Special Shoes in Individuals With Difficulties in Weight-bearing
Estimated Study Start Date : April 2017
Estimated Primary Completion Date : April 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Soft surface
A soft sponge used for physiotherapy is placed on the floor along a path,
Other: Soft surface
A sponge rectangle used in physiotherapy will be placed on the floor,

Other: Floor
A marked path on the floor where the subject is instructed to walk.

Other: Kyboot shoes
Special shoes will be worn by the subject.

Floor
The subject will walk on the floor.
Other: Soft surface
A sponge rectangle used in physiotherapy will be placed on the floor,

Other: Floor
A marked path on the floor where the subject is instructed to walk.

Other: Kyboot shoes
Special shoes will be worn by the subject.

Shoes
Special shoes (Kyboot) with air cushions that are meant to relieve pressure will be used.
Other: Soft surface
A sponge rectangle used in physiotherapy will be placed on the floor,

Other: Floor
A marked path on the floor where the subject is instructed to walk.

Other: Kyboot shoes
Special shoes will be worn by the subject.




Primary Outcome Measures :
  1. Gait velocity [ Time Frame: Two hours ]
    velocity [m/s]


Secondary Outcome Measures :
  1. Step length [ Time Frame: Two hours ]
    Step length [cm]

  2. Base width [ Time Frame: Two hours ]
    Base width [cm]

  3. Cadence [ Time Frame: Two hours ]
    Cadence [steps/s]

  4. Single limb support duration [ Time Frame: Two hours ]
    Single limb support time [s and % gait cycle time]

  5. Double limb support duration [ Time Frame: Two hours ]
    Double limb support time [s and % gait cycle time]



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02742376


Contacts
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Contact: Isabella Schwartz, MD 02-5844474 isabellas@hadassah.org.il
Contact: Hadas Lemberg, PhD 00 972 2 6777572 lhadas@hadassah.org.il

Sponsors and Collaborators
Hadassah Medical Organization

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Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT02742376     History of Changes
Other Study ID Numbers: Sponge- HMO-CTIL
First Posted: April 19, 2016    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: February 2016

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Back Pain
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Pain
Neurologic Manifestations
Signs and Symptoms
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases