Progressing Ankle Brace Restriction on Walking and Running Gait Characteristics in Healthy Individuals

NCT03641066 | Completed

• 1 other identifier: AnkleBrace Running
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Sprains

Keywords

ankle; biomechanics

Outcome Measures

Primary Outcomes (4)

• 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

  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.

• 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

  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.

• 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

  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.

• Change in Step Length

  Step Length will be measured using the Woodway Walker View Treadmill which utilizes load cells within the treadmill belt

  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.

Study Arms (1)

Ankle Brace

EXPERIMENTAL

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

Device: Ankle Brace

Interventions

Ankle Brace DEVICE

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)

Ankle Brace

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy individuals who are able to run for 10 minutes total

You may not qualify if:

• pregnancy, lower body injury

Sponsors & Collaborators

• Sport and Spine Rehab Clinical Research Foundation: lead

Study Sites (1)

Sport & Spine Rehab

Rockville, Maryland, 20852, United States

Location

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: August 21, 2018
• Study Start: April 1, 2018
• Primary Completion: September 1, 2018
• Study Completion: January 1, 2019
• Last Updated: March 25, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)