NCT02742376

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).

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 19, 2016

Completed
12 months until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Last Updated

February 14, 2017

Status Verified

February 1, 2016

Enrollment Period

1 year

First QC Date

March 2, 2016

Last Update Submit

February 12, 2017

Conditions

Arthroscopic Knee SurgeryLower Limb FracturesBack Pain and Asymmetric GaitComplex Regional Pain Syndrome

Outcome Measures

Primary Outcomes (1)

  • Gait velocity

    velocity \[m/s\]

    Two hours

Secondary Outcomes (5)

  • Step length

    Two hours

  • Base width

    Two hours

  • Cadence

    Two hours

  • Single limb support duration

    Two hours

  • Double limb support duration

    Two hours

Study Arms (3)

Soft surface

OTHER

A soft sponge used for physiotherapy is placed on the floor along a path,

Other: Soft surfaceOther: FloorOther: Kyboot shoes

Floor

OTHER

The subject will walk on the floor.

Other: Soft surfaceOther: FloorOther: Kyboot shoes

Shoes

OTHER

Special shoes (Kyboot) with air cushions that are meant to relieve pressure will be used.

Other: Soft surfaceOther: FloorOther: Kyboot shoes

Interventions

Soft surfaceOTHER

A sponge rectangle used in physiotherapy will be placed on the floor,

FloorShoesSoft surface
FloorOTHER

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

FloorShoesSoft surface
Kyboot shoesOTHER

Special shoes will be worn by the subject.

FloorShoesSoft surface

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Neurological condition that does not permit walking on soft surface (drop foot)
  • Wounds on feet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Back PainComplex Regional Pain Syndromes

Interventions

Floors and Floorcoverings

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAutonomic Nervous System DiseasesNervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular Diseases

Intervention Hierarchy (Ancestors)

Facility Design and ConstructionArchitectureTechnology, Industry, and Agriculture

Central Study Contacts

Isabella Schwartz, MD

CONTACT

02-5844474isabellas@hadassah.org.il

Hadas Lemberg, PhD

CONTACT

00 972 2 6777572lhadas@hadassah.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2016

First Posted

April 19, 2016

Study Start

April 1, 2017

Primary Completion

April 1, 2018

Last Updated

February 14, 2017

Record last verified: 2016-02