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

Complex Regional Pain Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02742376
• Other study ID #: Sponge- HMO-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: March 2, 2016
• Last updated: February 12, 2017
• Start date: April 2017

Study information

• Verified date: February 2016
• Source: Hadassah Medical Organization
• Contact: Isabella Schwartz, MD
• Phone: 02-5844474
• Email: isabellas[@]hadassah.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. primary completion date: April 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroscopic Knee Surgery
• Back Pain
• Back Pain and Asymmetric Gait
• Complex Regional Pain Syndrome
• Complex Regional Pain Syndromes
• Lower Limb Fractures
• Reflex Sympathetic Dystrophy

Intervention

Other:
• Soft surface
A sponge rectangle used in physiotherapy will be placed on the floor,
• Floor
A marked path on the floor where the subject is instructed to walk.
• Kyboot shoes
Special shoes will be worn by the subject.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait velocity	velocity [m/s]	Two hours
Secondary	Step length	Step length [cm]	Two hours
Secondary	Base width	Base width [cm]	Two hours
Secondary	Cadence	Cadence [steps/s]	Two hours
Secondary	Single limb support duration	Single limb support time [s and % gait cycle time]	Two hours
Secondary	Double limb support duration	Double limb support time [s and % gait cycle time]	Two hours