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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03641066
Enrollment
20
Registered
2018-08-21
Start date
2018-04-01
Completion date
2019-01-01
Last updated
2019-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Sprains

Keywords

ankle, biomechanics

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.

Interventions

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)

Sponsors

Sport and Spine Rehab Clinical Research Foundation
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* pregnancy, lower body injury

Design outcomes

Primary

MeasureTime frameDescription
Change in Ankle Dorsiflexion/Plantarflexion Range of MotionAnkle 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.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 MotionAnkle 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.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 MotionKnee 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.Knee Flexion Range of Motion will be measured using the Woodway Walker View Treadmill which utilizes a 3D camera
Change in Step LengthStep 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.Step Length will be measured using the Woodway Walker View Treadmill which utilizes load cells within the treadmill belt

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026