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

Ankle Sprains Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03641066
• Other study ID #: AnkleBrace Running
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: January 1, 2019

Study information

• Verified date: March 2019
• Source: Sport and Spine Rehab Clinical Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 1, 2019
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• pregnancy, lower body injury

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Sprains

Intervention

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)

Locations

Country	Name	City	State
United States	Sport & Spine Rehab	Rockville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Sport and Spine Rehab Clinical Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.