NCT03641066

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Sport and Spine Rehab Clinical Research Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Ankle Sprains

Interventions

Type	Name	Description
DEVICE	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)

Timeline

• Start date: 2018-04-01
• Primary completion: 2018-09-01
• Completion: 2019-01-01
• First posted: 2018-08-21
• Last updated: 2019-03-25

Locations

1 site across 1 country: United States