Progressing Ankle Brace Restriction on Walking and Running Gait Characteristics in Healthy Individuals
Primary Purpose
Ankle Sprains
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ankle Brace
Sponsored by
About this trial
This is an interventional basic science trial for Ankle Sprains focused on measuring ankle, biomechanics
Eligibility Criteria
Inclusion Criteria:
- healthy individuals who are able to run for 10 minutes total
Exclusion Criteria:
- pregnancy, lower body injury
Sites / Locations
- Sport & Spine Rehab
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ankle Brace
Arm Description
Each participant will complete a baseline analysis of 1 minute of walking and 2 minutes of running, repeated 4 more times wearing 4 different braces. The analysis will be completed on the Walker View Treadmill, which used 3D camera technology to capture lower body kinematics. The treadmill also has load cells built in to capture gait characteristics
Outcomes
Primary Outcome Measures
Change in Ankle Dorsiflexion/Plantarflexion Range of Motion
Ankle Dorsiflexion/Plantarflexion Range of Motion will be measured using the Woodway Walker View Treadmill which utilizes a 3D camera
Change in Ankle Inversion/Eversion Range of Motion
Ankle Inversion/Eversion Range of Motion will be measured using the Woodway Walker View Treadmill which utilizes a 3D camera
Change in Knee Flexion Range of Motion
Knee Flexion Range of Motion will be measured using the Woodway Walker View Treadmill which utilizes a 3D camera
Change in Step Length
Step Length will be measured using the Woodway Walker View Treadmill which utilizes load cells within the treadmill belt
Secondary Outcome Measures
Full Information
NCT ID
NCT03641066
First Posted
July 2, 2018
Last Updated
March 22, 2019
Sponsor
Sport and Spine Rehab Clinical Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT03641066
Brief Title
Progressing Ankle Brace Restriction on Walking and Running Gait Characteristics in Healthy Individuals
Official Title
The Effect of Progressing Ankle Brace Restriction on Walking and Running Gait Characteristics in Healthy Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
September 1, 2018 (Actual)
Study Completion Date
January 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sport and Spine Rehab Clinical Research Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A convenience sample of 20 participants, 18 years or older healthy individuals were recruited. Participants were excluded if they report being pregnant or being treated for a musculoskeletal injury. After explanation of the study and consent were obtained, each participant completed background information and the Cumberland Ankle Instability Tool (CAIT). Participants began by completing a 1 minute, 3mph walking gait assessment while unbraced, followed by a 2-minute, 6mph unbraced running assessment. Following the unbraced condition participants were randomly assigned into 1 of 4 conditions: [1] Active Ankle 329 Ankle Sleeve, [2] AS1Pro, [3] Eclipse 1, or [4] Eclipse 2. Participants placed an assigned brace on each ankle and then repeated the walking gait and running assessments. After this test the participants filled out a 10-item satisfaction questionnaire, and then were randomly assigned a second brace. The protocol was repeated until they have completed the walking, running, and satisfaction survey in all 4 brace conditions.
Detailed Description
A convenience sample of 20 participants, 18 years or older healthy individuals were recruited. Participants were excluded if they report being pregnant or being treated for a musculoskeletal injury. After explanation of the study and consent were obtained, each participant completed background information and the Cumberland Ankle Instability Tool (CAIT). Participants began by completing a 1 minute, 3mph walking gait assessment while unbraced, followed by a 2-minute, 6mph unbraced running assessment. Following the unbraced condition participants were randomly assigned into 1 of 4 conditions: [1] Active Ankle 329 Ankle Sleeve, [2] AS1Pro, [3] Eclipse 1, or [4] Eclipse 2. Participants placed an assigned brace on each ankle and then repeated the walking gait and running assessments. After this test the participants filled out a 10-item satisfaction questionnaire, and then were randomly assigned a second brace. The protocol was repeated until they have completed the walking, running, and satisfaction survey in all 4 brace conditions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Sprains
Keywords
ankle, biomechanics
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ankle Brace
Arm Type
Experimental
Arm Description
Each participant will complete a baseline analysis of 1 minute of walking and 2 minutes of running, repeated 4 more times wearing 4 different braces. The analysis will be completed on the Walker View Treadmill, which used 3D camera technology to capture lower body kinematics. The treadmill also has load cells built in to capture gait characteristics
Intervention Type
Device
Intervention Name(s)
Ankle Brace
Intervention Description
Each participant will complete the 1 minute walking and 2 minute running under 5 conditions [1] un-braced, [2] Active Ankle 329 Ankle Sleeve, [3] AS1Pro (a lace-up brace), [4] Eclipse 1 (single-upright brace), and [5] Eclipse 2 (double upright brace)
Primary Outcome Measure Information:
Title
Change in Ankle Dorsiflexion/Plantarflexion Range of Motion
Description
Ankle Dorsiflexion/Plantarflexion Range of Motion will be measured using the Woodway Walker View Treadmill which utilizes a 3D camera
Time Frame
Ankle Dorsiflexion/Plantarflexion Range of Motion will be measured for the last 30 seconds of the 1 minute walk, and the last 30 seconds of the 2 minute run. It will be measured during each of the 5 conditions.
Title
Change in Ankle Inversion/Eversion Range of Motion
Description
Ankle Inversion/Eversion Range of Motion will be measured using the Woodway Walker View Treadmill which utilizes a 3D camera
Time Frame
Ankle Inversion/Eversion Range of Motion will be measured for the last 30 seconds of the 1 minute walk, and the last 30 seconds of the 2 minute run. It will be measured during each of the 5 conditions.
Title
Change in Knee Flexion Range of Motion
Description
Knee Flexion Range of Motion will be measured using the Woodway Walker View Treadmill which utilizes a 3D camera
Time Frame
Knee Flexion Range of Motion will be measured for the last 30 seconds of the 1 minute walk, and the last 30 seconds of the 2 minute run. It will be measured during each of the 5 conditions.
Title
Change in Step Length
Description
Step Length will be measured using the Woodway Walker View Treadmill which utilizes load cells within the treadmill belt
Time Frame
Step Length will be measured for the last 30 seconds of the 1 minute walk, and the last 30 seconds of the 2 minute run. It will be measured during each of the 5 conditions.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy individuals who are able to run for 10 minutes total
Exclusion Criteria:
pregnancy, lower body injury
Facility Information:
Facility Name
Sport & Spine Rehab
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Progressing Ankle Brace Restriction on Walking and Running Gait Characteristics in Healthy Individuals
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