- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02606370
Effects of Unstable Shoes on Trunk Muscle Activity, Lumbar Spine Kinematics and Pain in Patients With Low Back Pain
Aim: To compare trunk muscle activity, lumbar spine range of motion (ROM) and LBP during gait using an unstable shoe (Intervention group) and a conventional stable control shoe (Control Group).
Design: Randomized Controlled Trial. Setting: A Biomechanics laboratory. Population: Patients with Low Back Pain.
Study Overview
Detailed Description
Background: An unstable shoe was developed as a walking device to strengthen the lower extremity muscles and reduce joint loading. A large number of studies have reported increased electromyographic (EMG) activity throughout the gait cycle in most of the lower limb muscles, and significant kinematic changes in the lower extremity. However, no studies have investigated the effects of wearing (1 month) unstable shoes on 1) spine kinematics, 2) trunk muscle activity and 3) Low Back Pain (LBP) during gait in Patients with chronic LBP.
Aim: To compare trunk muscle activity, lumbar spine range of motion (ROM) and LBP during gait using an unstable shoe (Intervention group) and a conventional stable control shoe (Control Group).
Design: Randomized Controlled Trial. Setting: A Biomechanics laboratory. Population: Patients with Low Back Pain.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Valencia
-
Moncada, Valencia, Spain, 46113
- University CEU Cardenal Herrera
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with Chronic LBP
- BMI < 30
Exclusion Criteria:
- Hernia
- Lower limb pathologies
- Previous experience with unstable shoes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Unstable shoes
Wearing unstable shoes during 1 month
|
Wearing Unstable shoes during 1 month
|
NO_INTERVENTION: Control Group
Not Wearing unstable shoes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Disability (assessed by Roland Morris Questionaire)
Time Frame: At 1 month
|
At 1 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
EMG activity of trunk muscles
Time Frame: At baseline and at 1 month follow-up
|
At baseline and at 1 month follow-up
|
Lumbar spine range of movement (sagittal plane)
Time Frame: At baseline and at 1 month follow-up
|
At baseline and at 1 month follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: JF Lisón, Dr., Cardenal Herrera University
- Principal Investigator: Pablo Salvador-Coloma, Cardenal Herrera University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UNIVERSITY CARDENAL HERRERA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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