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

NCT ID: NCT03641066

Last Updated: 2019-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2019-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Ankle Sprains

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ankle Brace

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

Group Type EXPERIMENTAL

Ankle Brace

Intervention Type 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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ankle Brace

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)

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* pregnancy, lower body injury
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sport and Spine Rehab Clinical Research Foundation

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sport & Spine Rehab

Rockville, Maryland, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AnkleBrace Running

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Validation of a Portable Ankle Arthrometer
NCT07163897 NOT_YET_RECRUITING