Sensory-Targeted Ankle Rehabilitation Strategies (STARS)

NCT ID: NCT01541657

Last Updated: 2018-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2014-04-30

Brief Summary

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The purpose of this study is to determine the effect of 3 types of sensory-targeted rehabilitation interventions on subjective and objective measures of function for those with chronic ankle instability. The investigators hypothesize that subjective and objective measures of function including self-reported disability, balance, and range of motion will improve after 2-weeks of sensory-targeted interventions.

Detailed Description

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The purpose of this study is to determine the effect of 3 types of sensory-targeted rehabilitation interventions on subjective and objective measures of function for those with chronic ankle instability. If a potential participant is deemed eligible for participation and consents to participate, he/she undergo a pretest session in which balance, gait, and range of motion will be assessed. The participant will then be randomized into one of the 4 treatment groups and undergo the first treatment which takes approximately 5 minutes. After completion of the first treatment, the participant will be immediately retested on the balance, gait, and range of motion measures. Upon completion of testing on the first day, participants in the treatment groups will be asked to return for 5 more treatments over the course of 2 weeks. Upon completion of the treatments, each participant will be tested on their balance, gait, and range of motion again. Then, after 1 month, each participant will be contacted to do a self-reported function follow-up visit in which he/she will be asked to report how stable and functional his/her ankle has been over the past month.

Conditions

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Chronic Ankle Instability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control Group

This group will only take part in the data collection sessions. After the first testing session (Pre-Intervention) the participants will be asked to rest comfortably for 5 minutes. After the rest period, they will be reassessed. Upon completion of the second testing, they will be asked to maintain the same lifestyle over the course of 2 weeks. They will then be asked to return to the lab after the 2 week interval to be tested again. Upon completion of the third testing session, they will be contacted after 1 month to complete the self-reported function questionnaires.

Group Type NO_INTERVENTION

No interventions assigned to this group

Ankle Joint Mobilization

The posterior ankle mobilization treatment is a manual therapy technique that consists of gently gliding your ankle in the backward direction through a pain free range of motion. This is a common therapy technique used by athletic trainers for the treatment of ankle sprains. The objective of this therapy technique is to glide the ankle into the area which restricts range of motion and gently stretch the restricted area. To begin this treatment, a certified athletic trainer with experience in applying this therapy technique will provide mild traction to the ankle joint to lightly distract the bones of the ankle joint. The athletic trainer will then apply two sets of joint mobilizations which will each last 2 minutes. Each repetition will consist of gently gliding the ankle joint in the backward direction until an area of restriction is reached. The athletic trainer will push into the restriction and then glide the ankle back to the starting position.

Group Type EXPERIMENTAL

Ankle Joint Mobilization

Intervention Type OTHER

The posterior ankle mobilization treatment is a manual therapy technique that consists of gently gliding your ankle in the backward direction through a pain free range of motion. This is a common therapy technique used by athletic trainers for the treatment of ankle sprains. The objective of this therapy technique is to glide the ankle into the area which restricts range of motion and gently stretch the restricted area. To begin this treatment, a certified athletic trainer with experience in applying this therapy technique will provide mild traction to the ankle joint to lightly distract the bones of the ankle joint. The athletic trainer will then apply two sets of joint mobilizations which will each last 2 minutes. Each repetition will consist of gently gliding the ankle joint in the backward direction until an area of restriction is reached. The athletic trainer will push into the restriction and then glide the ankle back to the starting position.

Foot Massage

The foot massage treatment is a manual therapy technique that consists of gently rubbing the bottom of your feet with both hands like kneading dough. To begin the treatment, you will be asked to lie comfortably on a treatment table you're your feet hanging slightly off the edge. The athletic trainer with experience in applying this therapy will place his hands on the bottom of your foot and begin to massage your feet from your toes down to your heel. The athletic trainer will perform 2 sets of 2 minutes of massage with 1 minute rest in between sets.

Group Type EXPERIMENTAL

Foot Massage

Intervention Type OTHER

The foot massage treatment is a manual therapy technique that consists of gently rubbing the bottom of your feet with both hands like kneading dough. To begin the treatment, you will be asked to lie comfortably on a treatment table you're your feet hanging slightly off the edge. The athletic trainer with experience in applying this therapy will place his hands on the bottom of your foot and begin to massage your feet from your toes down to your heel. The athletic trainer will perform 2 sets of 2 minutes of massage with 1 minute rest in between sets.

Calf Stretching

The calf stretching treatment is a technique that is commonly used in sports and rehabilitation. You will be asked to place your foot on a slant board located next to a wall with your heel positioned below your toes on the slant board. You will be asked to lean towards the wall until you feel tension in your calf muscles that feels like a good stretch. You will perform 2 sets of 3 stretches that are held for 30 seconds each. Between each stretch, you will rest for 10 seconds. Between each set, you will rest for 1 minute.

Group Type EXPERIMENTAL

Calf Stretching

Intervention Type OTHER

The calf stretching treatment is a technique that is commonly used in sports and rehabilitation. You will be asked to place your foot on a slant board located next to a wall with your heel positioned below your toes on the slant board. You will be asked to lean towards the wall until you feel tension in your calf muscles that feels like a good stretch. You will perform 2 sets of 3 stretches that are held for 30 seconds each. Between each stretch, you will rest for 10 seconds. Between each set, you will rest for 1 minute.

Interventions

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Ankle Joint Mobilization

The posterior ankle mobilization treatment is a manual therapy technique that consists of gently gliding your ankle in the backward direction through a pain free range of motion. This is a common therapy technique used by athletic trainers for the treatment of ankle sprains. The objective of this therapy technique is to glide the ankle into the area which restricts range of motion and gently stretch the restricted area. To begin this treatment, a certified athletic trainer with experience in applying this therapy technique will provide mild traction to the ankle joint to lightly distract the bones of the ankle joint. The athletic trainer will then apply two sets of joint mobilizations which will each last 2 minutes. Each repetition will consist of gently gliding the ankle joint in the backward direction until an area of restriction is reached. The athletic trainer will push into the restriction and then glide the ankle back to the starting position.

Intervention Type OTHER

Foot Massage

The foot massage treatment is a manual therapy technique that consists of gently rubbing the bottom of your feet with both hands like kneading dough. To begin the treatment, you will be asked to lie comfortably on a treatment table you're your feet hanging slightly off the edge. The athletic trainer with experience in applying this therapy will place his hands on the bottom of your foot and begin to massage your feet from your toes down to your heel. The athletic trainer will perform 2 sets of 2 minutes of massage with 1 minute rest in between sets.

Intervention Type OTHER

Calf Stretching

The calf stretching treatment is a technique that is commonly used in sports and rehabilitation. You will be asked to place your foot on a slant board located next to a wall with your heel positioned below your toes on the slant board. You will be asked to lean towards the wall until you feel tension in your calf muscles that feels like a good stretch. You will perform 2 sets of 3 stretches that are held for 30 seconds each. Between each stretch, you will rest for 10 seconds. Between each set, you will rest for 1 minute.

Intervention Type OTHER

Other Intervention Names

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Ankle Range of Motion Joint Manipulation Plantar Massage Plantar Stimulation Foot Rub Muscle Stretch Flexibility

Eligibility Criteria

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Inclusion Criteria

1. Male or female 18-45 years of age
2. History of ankle sprain with at least two episodes of "giving way" within the past six months
3. Score of ≥ 5 on the Ankle Instability Instrument (AII)
4. Score of ≤ 90% on the Foot and Ankle Ability Measure (FAAM)- Activity of Daily Living (ADL) Subscale
5. Score of ≤ 80% on the FAAM-Sport Subscale.

Exclusion Criteria

1. Younger than 18 or older than 45 years
2. No history of ankle sprain or episodes of "giving way" in the past six months
3. Score of ≤ 5 on the Ankle Instability Instrument (AII)
4. Score of ≥ 90% on the FAAM-ADL
5. Score of ≥ 80% on the FAAM-S.
6. An acute ankle sprain within the past 6 weeks.
7. Previous history of lower extremity surgery with internal derangements, reconstructions, or repair
8. Lower extremity injury within the past 6 months (other than ankle sprains)
9. Presence of balance deficits or conditions known to affect balance as noted on the Balance Questionnaire including diabetes and/or vertigo.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ithaca College

OTHER

Sponsor Role collaborator

University of North Carolina, Charlotte

OTHER

Sponsor Role collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role collaborator

Joel Thompson

OTHER

Sponsor Role lead

Responsible Party

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Joel Thompson

UK PRS Adminstrator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Patrick O McKeon, PhD

Role: PRINCIPAL_INVESTIGATOR

Ithaca College

Erik A Wikstrom, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Charlotte

Locations

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Ithaca College

Ithaca, New York, United States

Site Status

University of North Carolina Charlotte

Charlotte, North Carolina, United States

Site Status

Countries

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United States

References

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McKeon PO, Wikstrom EA. The effect of sensory-targeted ankle rehabilitation strategies on single-leg center of pressure elements in those with chronic ankle instability: A randomized clinical trial. J Sci Med Sport. 2019 Mar;22(3):288-293. doi: 10.1016/j.jsams.2018.08.017. Epub 2018 Sep 6.

Reference Type DERIVED
PMID: 30244979 (View on PubMed)

Other Identifiers

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R03AR06156101

Identifier Type: -

Identifier Source: org_study_id

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