Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2026-02-25 @ 8:18 PM
Study NCT ID:
NCT03641066
Status:
COMPLETED
Last Update Posted:
2019-03-25
First Post:
2018-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Progressing Ankle Brace Restriction on Walking and Running Gait Characteristics in Healthy Individuals
Sponsor:
Sport and Spine Rehab Clinical Research Foundation
Organization:
Study Overview
Official Title:
The Effect of Progressing Ankle Brace Restriction on Walking and Running Gait Characteristics in Healthy Individuals
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: