Recruiting

Mobilization & Exercise

Sponsor:

Shenandoah University

Code:

NCT03428620

Conditions

Ankle Sprains

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

Interventions

High Velocity Low Amplitude mobilization

Exercise protocol

Study Details

Brief summary:

Our purpose is to examine the combined effects of thrust mobilization of the ankle joints in conjunction with a six-week rehabilitation program on functional performance in subjects reporting chronic ankle instability (CAI).

Conditions

Ankle Sprains

Study ID

NCT03428620

Start date

Feb 14, 2018

Status verified date

Apr, 2018

Completion date

Jun, 2019

Anticipated

Primary completion date

Jan, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

As adapted from the position statement from the international ankle consortium.

Inclusion Criteria:

  • 18-35 years of age
  • A history of at least 1 significant ankle sprain (The initial sprain must have occurred at least 12 months prior to study enrollment, associated with inflammatory symptoms (pain, swelling, etc), created at least 1 interrupted day of desired physical activity)
  • The most recent injury must have occurred more than 3 months prior to study enrollment.
  • A history of the previously injured ankle joint "giving way" and/or recurrent sprain and/or "feelings of instability."
  • Cumberland Ankle Instability Tool (CAIT) < 24
  • Foot and Ankle Ability Measure (FAAM)42: ADL scale < 90%, Sport scale < 80%

Exclusion Criteria:

  • A history of previous surgeries to the musculoskeletal structures (ie, bones, joint structures, nerves) in either limb of the lower extremity.
  • A history of a fracture in either limb of the lower extremity requiring realignment
  • Acute injury to musculoskeletal structures of other joints of the lower extremity in the previous 3 months, which impacted joint integrity and function (ie, sprains, fractures) resulting in at least 1 interrupted day of desired physical activity

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Mobilization

High Velocity Low Amplitude mobilization group. The three joints that will be manipulated include proximal tibiofibular, the distal tibiofibular, and talocrural joints and will be mobilized the first three sessions prior to the participants performing the exercise protocol.

active comparator: Exercise Protocol

This exercise regimen is a modified version of the balance training program described by McKeon et al.

Interventions

High Velocity Low Amplitude mobilization

Mobilizations will be performed one time at each joint, prior to completing the exercise protocol during the first three treatment sessions.

Exercise protocol

This exercise regimen is a modified version of the balance training program described by McKeon et al.

Primary outcome measure

  • Change in baseline Figure-of-8 hop test at 6 weeks. [ Time Frame: Baseline and 6 weeks ]
  • Change in baseline Side hop test at 6 weeks [ Time Frame: Baseline and 6 weeks ]
  • Change in baseline Star Excursion Balance Test (SEBT) at 6 weeks [ Time Frame: Baseline and 6 weeks ]
  • Change in baseline Foot and Ankle Ability Measure (FAAM)- Activities of Daily Living (ADL) Subscale at 6 weeks [ Time Frame: Baseline and 6 weeks ]
  • Change in baseline Foot and Ankle Ability Measure (FAAM)- Sport subscale at 6 weeks [ Time Frame: Baseline and 6 weeks ]
  • Change in baseline Ankle Joint Functional Assessment Tool (AJFAT) at 6 weeks [ Time Frame: Baseline and 6 weeks ]
  • Change in baseline Cumberland Ankle Instability Tool (CAIT) at 6 weeks. [ Time Frame: Baseline and 6 weeks ]

Central Contacts and Locations

Central contacts

Cameron J Bolton, DPT

5405426540cbolton16@su.edu

Sheri Hale, PhD, PT

5405457240shale2@su.edu

Locations

Methodist University

Recruiting

Fayetteville, North Carolina, United States, 28311

Contacts

Todd Telemeco, DPT, PhD

910-630-7216ttelemeco@methodist.edu

Principal Investigator:

Todd A Telemeco, DPT, PhD

Shenandoah University

Recruiting

Winchester, Virginia, United States, 22601

Contacts

Cameron Bolton, DPT

540-542-6540cbolton16@su.edu

Sheri, PhD, PT

5405457240shale2@su.edu

More Information

Sponsor

Shenandoah University

Last update posted

Apr 17, 2018

Last verified

Apr, 2018

Keywords

  • Functional Performance
  • Rehabilitation
  • Manipulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Shenandoah University on 2018-04-17.