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

Comparison of Gait Parameters Between Floor and Sponge Surfaces and Special Shoes in Individuals With Difficulties in Weight-bearing

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

Study Overview

• Status: Unknown
• Conditions: Complex Regional Pain Syndrome; Arthroscopic Knee Surgery; Lower Limb Fractures; Back Pain and Asymmetric Gait
• Intervention / Treatment: Other: Soft surface; Other: Floor; Other: Kyboot shoes

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.
Other: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait velocity	velocity [m/s]	Two hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Step length	Step length [cm]	Two hours
Base width	Base width [cm]	Two hours
Cadence	Cadence [steps/s]	Two hours
Single limb support duration	Single limb support time [s and % gait cycle time]	Two hours
Double limb support duration	Double limb support time [s and % gait cycle time]	Two hours

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2017
• Primary Completion (Anticipated): April 1, 2018

Study Registration Dates

• First Submitted: March 2, 2016
• First Submitted That Met QC Criteria: April 13, 2016
• First Posted (Estimate): April 19, 2016

Study Record Updates

• Last Update Posted (Actual): February 14, 2017
• Last Update Submitted That Met QC Criteria: February 12, 2017
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Autonomic Nervous System Diseases; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy
• Other Study ID Numbers: Sponge- HMO-CTIL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No