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

• Sponsor: Hadassah Medical Organization (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02742376
• Collaborator: (none)
• Enrollment: 40
• Arms: 3

Study Details

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).

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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
• Anticipated Study Start Date: Apr 1, 2017
• Anticipated Primary Completion Date: Apr 1, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Gait velocity [Two hours]

   velocity [m/s]

Secondary Outcome Measures

1. Step length [Two hours]

   Step length [cm]

2. Base width [Two hours]

   Base width [cm]

3. Cadence [Two hours]

   Cadence [steps/s]

4. Single limb support duration [Two hours]

   Single limb support time [s and % gait cycle time]

5. Double limb support duration [Two hours]

   Double limb support time [s and % gait cycle time]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Hadassah Medical Organization

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hadassah Medical Organization
• ClinicalTrials.gov Identifier: NCT02742376
• Other Study ID Numbers: Sponge- HMO-CTIL
• First Posted: Apr 19, 2016
• Last Update Posted: Feb 14, 2017
• Last Verified: Feb 1, 2016

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy

Study Results

No Results Posted as of Feb 14, 2017