Arthroscopic Knee SurgeryNCT02742376
Comparison of Gait Parameters Between Floor and Sponge Surfaces and Special Shoes
A study testing Soft surface, Floor and Kyboot shoes in people with Arthroscopic Knee Surgery and Lower Limb Fractures, run by Hadassah Medical Organization.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arthroscopic Knee Surgery, Lower Limb Fractures, Back Pain and Asymmetric Gait
- What is being tested?
- Soft surface, Floor and Kyboot shoes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Apr 2017to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Neurological condition that does not permit walking on soft surface (drop foot)
- Wounds on feet
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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).
- Conditions
- Arthroscopic Knee Surgery, Lower Limb Fractures, Back Pain and Asymmetric Gait, Complex Regional Pain Syndrome
- Being tested
- Soft surface, Floor, Kyboot shoes
- Medical subject headings
- Back Pain, Complex Regional Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft surfaceOther
A sponge rectangle used in physiotherapy will be placed on the floor,
FloorOther
A marked path on the floor where the subject is instructed to walk.
Kyboot shoesOther
Special shoes will be worn by the subject.
| Study group | Role | What they receive |
|---|---|---|
| Soft surface | Other | A soft sponge used for physiotherapy is placed on the floor along a path, Receives: Other: Soft surface; Other: Floor; Other: Kyboot shoes |
| Floor | Other | The subject will walk on the floor. Receives: Other: Soft surface; Other: Floor; Other: Kyboot shoes |
| Shoes | Other | Special shoes (Kyboot) with air cushions that are meant to relieve pressure will be used. Receives: Other: Soft surface; Other: Floor; Other: Kyboot shoes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait velocity
velocity [m/s]
Measured: Two hours
Secondary outcomes (5)
Step length
Step length [cm]
Measured: Two hours
Base width
Base width [cm]
Measured: Two hours
Cadence
Cadence [steps/s]
Measured: Two hours
Single limb support duration
Single limb support time [s and % gait cycle time]
Measured: Two hours
Double limb support duration
Double limb support time [s and % gait cycle time]
Measured: Two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startApr 2017 (estimated)
- Primary completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroscopic Knee SurgeryStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742376
- Sponsor's protocol ID
- Sponge- HMO-CTIL
- Status last verified
- Feb 2016
- First submitted
- 2 Mar 2016
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Gait Parameters Between Floor and Sponge Surfaces and Special Shoes in Individuals With Difficulties in Weight-bearing
- ClinicalTrials.gov ID
- NCT02742376
- Acronym / sponsor ID
- Sponge- HMO-CTIL
- Conditions
- Arthroscopic Knee Surgery, Lower Limb Fractures, Back Pain and Asymmetric Gait, Complex Regional Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Apr 2017 (estimated)
- Primary completion
- Apr 2018 (estimated)
- First posted
- 19 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Soft surface | Other | Other: Soft surface, Other: Floor, Other: Kyboot shoesA soft sponge used for physiotherapy is placed on the floor along a path, |
| Floor | Other | Other: Soft surface, Other: Floor, Other: Kyboot shoesThe subject will walk on the floor. |
| Shoes | Other | Other: Soft surface, Other: Floor, Other: Kyboot shoesSpecial shoes (Kyboot) with air cushions that are meant to relieve pressure will be used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- Neurological condition that does not permit walking on soft surface (drop foot)
- Wounds on feet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soft surfaceA sponge rectangle used in physiotherapy will be placed on the floor, | Other | Floor, Shoes, Soft surface |
| FloorA marked path on the floor where the subject is instructed to walk. | Other | Floor, Shoes, Soft surface |
| Kyboot shoesSpecial shoes will be worn by the subject. | Other | Floor, Shoes, Soft surface |
Primary outcome
Gait velocity
Time frame: Two hours
velocity [m/s]
5 secondary outcomes
Step length
Time frame: Two hours
Base width
Time frame: Two hours
Cadence
Time frame: Two hours
Single limb support duration
Time frame: Two hours
Double limb support duration
Time frame: Two hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2017.
Related trials for Arthroscopic Knee Surgery
Recruiting
Blood Flow Restriction Training in Knee Arthropathy
Knee Arthroscopic Surgery, Arthrogenic Muscle Inhibition
Not yet recruiting
The Effect of White and Pink Noise in Patients Undergoing Total Hip and Knee Arthroplasty
Arthroplasty, Replacement, Knee, Hip, Postoperative Nausea and Vomiting
Recruiting
The Effect of Nutritional Education on Post-Arthroscopic Nutritional Status
Arthroscopic Surgery, Nutrition
Active, not recruitingPhase 3
Dronabinol After Arthroscopic Surgery
Knee Osteoarthritis, Knee Injuries
Active, not recruiting
Active Noise-Cancelling Headphones With Closed-Loop Communication During Arthroscopic ACL Reconstruction
Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament (ACL) Tear
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Soft surface, Floor and Kyboot shoes in people with Arthroscopic Knee Surgery and Lower Limb Fractures, run by Hadassah Medical Organization.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabella Schwartz, MD (02-5844474, isabellas@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait velocity (time frame: Two hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2017.