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The Effect of Balance Training Following STARS on Postural Control

Primary Purpose

Kinesiophobia, Ankle Sprains, Sensory Deficit

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise
STARS (Sensory-Targeted Ankle Rehabilitation Strategies)
Sponsored by
Bahçeşehir University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kinesiophobia

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: History of first ankle sprain more than 1 year ago Having at least 2 "give away" episodes in the last 6 months Identification of Functional Ankle Instability's score above 11 18-25 age range Foot and Ankle Ability Measure (FAAM), the score of which is less than %90 Foot and Ankle Ability Measure Sports scale (FAAM-S), the score of which is less than %80 Exclusion Criteria: History of lower extremity surgery History of disease that may affect sensorimotor function in the lower extremity Musculoskeletal disorders that may affect balance

Sites / Locations

  • Bahcesehir University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Balance training:

STARS

Combined Training

Arm Description

It is planned to apply hop to stabilization exercises developed by Mckeon et al. The training will be given for 6 weeks, 3 times a week for 20 minutes. This phased balance training program is based on the participant's ability to maintain a single limb posture while performing balance activities. The program includes: 1) hop to stabilization, 2) hop to stabilization and reach, 3) hop to stabilization box drill, 4) progressive single-limb stance balance activities with eyes open, and 5) progressive single-limb stance activities with eyes closed. Participants will be followed up with a physiotherapist and will be able to proceed to the next stage of the test after completing the previous level without errors.

A combination of STARS developed by Mckeon et al. is planned for the STARS group. The training will be given for 6 weeks, 3 times a week for 5 minutes. STARS includes; joint mobilization, plantar massage and triceps surae stretching.

Each participant in the combined training program will receive 4 weeks of balance training after 2 weeks of STARS treatment. STARS and hop to stabilization treatment protocol will be applied in the same way.

Outcomes

Primary Outcome Measures

Postural control evaluation change
Star excursion balance test (SEBT): The star excursion balance test is frequently used to evaluate the dynamic balance and postural control of the lower extremities. SEBT, is a test that measures the maximum reach of the individual by maintaining balance and performing a single-leg squat in lines drawn at 45 degrees intervals in eight different directions. The participant stands in the middle of the star shape with bare feet. For the starting position, the ankle should be stationary, the hands on the hips, and the participant should maintain the starting position throughout the test. The participant is asked to reach anteriorly, posteromedially and posterolaterally with the unstable ankle, make a light touch to the line, and rotate the outstretched leg back to the center while maintaining a one-leg stance with the other leg.The participant will be allowed to make 4 trials in each direction

Secondary Outcome Measures

Ankle dorsiflexion measurement change
Weight-bearing lunge test (WBLT) is frequently used in individuals with ankle instability in order to determine dorsiflexion normal joint movement. During WBLT the participant puts his hands on the wall and takes one leg forward and the other leg helps balance behind. The maximum distance that the knee touches the wall is recorded without allowing the heel of the front foot to lose contact with the ground.
Function change
The Foot and Ankle Ability Measure is used to assess self-reported overall function levels in patients with leg, ankle, and foot musculoskeletal injuries and disorders. It consists of 2 subscales (Activities of Daily Living [ADL] and Sports [S]), both scored between 0% and 100%. The FAAM-ADL is a 21-item scale to assess function during activities of daily living. FAAM-Sport is an 8-item scale focusing on sports-related activities. Items in both tools are scored on a 5-point Likert scale ranging from 0 (no difficulty at all) to 4 (I can't do it). Scores are converted to percentages, and a higher percentage indicates a better level of function.
Kinesiophobia change
The Tampa kinesiophobia scale is often used in musculoskeletal injuries. TKS has a checklist of 17 questions. A 4-point Likert scoring (1= I strongly disagree, 4= I totally agree) is used in the scale. After reversing items 4, 8, 12 and 16, a total score is calculated. The person gets a total score between 17-68. A high score on the scale indicates a high level of kinesiophobia.

Full Information

First Posted
October 26, 2022
Last Updated
January 30, 2023
Sponsor
Bahçeşehir University
Collaborators
Nevsehir Haci Bektas Veli University
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1. Study Identification

Unique Protocol Identification Number
NCT05602233
Brief Title
The Effect of Balance Training Following STARS on Postural Control
Official Title
The Effect of Balance Training Following STARS on Postural Control and Function in Athletes With Chronic Ankle Instability
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
January 1, 2023 (Actual)
Study Completion Date
January 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bahçeşehir University
Collaborators
Nevsehir Haci Bektas Veli University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Chronic ankle instability (CAI) is defined as the symptoms continuing 12 months after the first sprain and the functional and/or mechanical instability reported by the individual. The number of researches that include a combined treatment approach that will affect both sensory and motor components in rehabilitation strategies applied for CAI is limited. The aim of this study is to isolated sensory, isolated motor and combined targeted approaches for the treatment of chronic ankle instability (CAI); to compare the effects on postural control, range of motion, function and kinesiophobia and to contribute to an effective approach related to the applicability of Sensory-Targeted Ankle Rehabilitation Strategies in the treatment of CAI.
Detailed Description
Lateral ankle sprains are among the most common injuries in athletes and physically active individuals, accounting for 80% of ankle injuries. After the ankle is sprained for the first time, it becomes more prone to re-injury. Chronic ankle instability (CAI) is defined as the symptoms continuing 12 months after the first sprain and the functional and/or mechanical instability reported by the individual. Long-term ongoing CAI symptoms; It includes pain, swelling, give away that reduces the person's quality of life. Symptoms of CAI include both motor and sensory aspects of the sensorimotor system. Despite sensory and motor deficits in sensorimotor control, researches on CAI rehabilitation have focused on either motor or sensory components. The number of researches that include a combined treatment approach that will affect both sensory and motor components in rehabilitation strategies applied for CAI is limited. Sensory-Targeted Ankle Rehabilitation Strategies (STARS) and balance training have proven to be effective in relieving CAI-associated deficits. Although the effects of isolated STARS were positive, in a recent study, there was no statistically significant difference between the groups when the balance training given with STARS was compared with the balance training alone. However, the reason for the lack of difference between the groups may be the simultaneous application of both treatment protocols. In addition, the effects of the isolated use of the STARS combination in the treatment of CAI are still unclear and to our knowledge, there are no studies in this area. The aim of this study is to isolated sensory, isolated motor and combined targeted approaches for the treatment of chronic ankle instability (CAI); to compare the effects on postural control, range of motion, function and kinesiophobia and to contribute to an effective approach related to the applicability of STARS in the treatment of CAI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kinesiophobia, Ankle Sprains, Sensory Deficit, Ankle Instability, Functional Performance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants between the ages of 18-25, diagnosed with chronic ankle sprain who met the inclusion criteria will be included in the study. Sample size of the study is calculated as 21. All evaluations of the participants, including postural control, weight bearing dorsiflexion angle measurement, function and kinesiophobia will be made by the same physiotherapist. The physiotherapist who made the evaluations will not know which treatment method will be applied to the participants.
Masking
Outcomes Assessor
Masking Description
The physiotherapist who made the evaluations will be blind to the groups. He will not know which treatment method will be applied to the participants.
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Balance training:
Arm Type
Experimental
Arm Description
It is planned to apply hop to stabilization exercises developed by Mckeon et al. The training will be given for 6 weeks, 3 times a week for 20 minutes. This phased balance training program is based on the participant's ability to maintain a single limb posture while performing balance activities. The program includes: 1) hop to stabilization, 2) hop to stabilization and reach, 3) hop to stabilization box drill, 4) progressive single-limb stance balance activities with eyes open, and 5) progressive single-limb stance activities with eyes closed. Participants will be followed up with a physiotherapist and will be able to proceed to the next stage of the test after completing the previous level without errors.
Arm Title
STARS
Arm Type
Experimental
Arm Description
A combination of STARS developed by Mckeon et al. is planned for the STARS group. The training will be given for 6 weeks, 3 times a week for 5 minutes. STARS includes; joint mobilization, plantar massage and triceps surae stretching.
Arm Title
Combined Training
Arm Type
Experimental
Arm Description
Each participant in the combined training program will receive 4 weeks of balance training after 2 weeks of STARS treatment. STARS and hop to stabilization treatment protocol will be applied in the same way.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
The training will be given for 6 weeks, 3 times a week for 20 minutes. This phased balance training program is based on the participant's ability to maintain a single limb posture while performing balance activities. The program includes: 1) hop to stabilization, 2) hop to stabilization and reach, 3) hop to stabilization box drill, 4) progressive single-limb stance balance activities with eyes open, and 5) progressive single-limb stance activities with eyes closed. Participants will be followed up with a physiotherapist and will be able to proceed to the next stage of the test after completing the previous level without errors.
Intervention Type
Other
Intervention Name(s)
STARS (Sensory-Targeted Ankle Rehabilitation Strategies)
Intervention Description
STARS includes; joint mobilization, plantar massage and triceps surae stretching. The training will be given for 6 weeks, 3 times a week for 5 minutes.
Primary Outcome Measure Information:
Title
Postural control evaluation change
Description
Star excursion balance test (SEBT): The star excursion balance test is frequently used to evaluate the dynamic balance and postural control of the lower extremities. SEBT, is a test that measures the maximum reach of the individual by maintaining balance and performing a single-leg squat in lines drawn at 45 degrees intervals in eight different directions. The participant stands in the middle of the star shape with bare feet. For the starting position, the ankle should be stationary, the hands on the hips, and the participant should maintain the starting position throughout the test. The participant is asked to reach anteriorly, posteromedially and posterolaterally with the unstable ankle, make a light touch to the line, and rotate the outstretched leg back to the center while maintaining a one-leg stance with the other leg.The participant will be allowed to make 4 trials in each direction
Time Frame
Change from Baseline postural control at 6 weeks
Secondary Outcome Measure Information:
Title
Ankle dorsiflexion measurement change
Description
Weight-bearing lunge test (WBLT) is frequently used in individuals with ankle instability in order to determine dorsiflexion normal joint movement. During WBLT the participant puts his hands on the wall and takes one leg forward and the other leg helps balance behind. The maximum distance that the knee touches the wall is recorded without allowing the heel of the front foot to lose contact with the ground.
Time Frame
Change from baseline ankle dorsiflexion measurement at 6 weeks
Title
Function change
Description
The Foot and Ankle Ability Measure is used to assess self-reported overall function levels in patients with leg, ankle, and foot musculoskeletal injuries and disorders. It consists of 2 subscales (Activities of Daily Living [ADL] and Sports [S]), both scored between 0% and 100%. The FAAM-ADL is a 21-item scale to assess function during activities of daily living. FAAM-Sport is an 8-item scale focusing on sports-related activities. Items in both tools are scored on a 5-point Likert scale ranging from 0 (no difficulty at all) to 4 (I can't do it). Scores are converted to percentages, and a higher percentage indicates a better level of function.
Time Frame
Change from baseline ankle function measurement at 6 weeks
Title
Kinesiophobia change
Description
The Tampa kinesiophobia scale is often used in musculoskeletal injuries. TKS has a checklist of 17 questions. A 4-point Likert scoring (1= I strongly disagree, 4= I totally agree) is used in the scale. After reversing items 4, 8, 12 and 16, a total score is calculated. The person gets a total score between 17-68. A high score on the scale indicates a high level of kinesiophobia.
Time Frame
Change from baseline kinesiophobia measurement at 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: History of first ankle sprain more than 1 year ago Having at least 2 "give away" episodes in the last 6 months Identification of Functional Ankle Instability's score above 11 18-25 age range Foot and Ankle Ability Measure (FAAM), the score of which is less than %90 Foot and Ankle Ability Measure Sports scale (FAAM-S), the score of which is less than %80 Exclusion Criteria: History of lower extremity surgery History of disease that may affect sensorimotor function in the lower extremity Musculoskeletal disorders that may affect balance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pelin Pişirici, PhD, PT
Organizational Affiliation
Bahçeşehir University, Faculty of Health Sciences, Physiotherapy and Rehabilitation Department
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Serkan Uzlaşır, PhD, PT
Organizational Affiliation
Nevsehir Haci Bektas Unıversity, Faculty of Sports Sciences, Department of Coaching Education
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Aynur Merve Zümre, PT
Organizational Affiliation
Bahçeşehir University, Graduate Education Institute, Physical Therapy and Rehabilitation Program
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bahcesehir University
City
Beşiktaş
State/Province
İstanbul
ZIP/Postal Code
34353
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Balance Training Following STARS on Postural Control

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