The Effect of Balance Training Following STARS on Postural Control
1 other identifier
interventional
21
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2022
CompletedStudy Start
First participant enrolled
November 1, 2022
CompletedFirst Posted
Study publicly available on registry
November 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2023
CompletedJanuary 31, 2023
January 1, 2023
2 months
October 26, 2022
January 30, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
Change from Baseline postural control at 6 weeks
Secondary Outcomes (3)
Ankle dorsiflexion measurement change
Change from baseline ankle dorsiflexion measurement at 6 weeks
Function change
Change from baseline ankle function measurement at 6 weeks
Kinesiophobia change
Change from baseline kinesiophobia measurement at 6 weeks
Study Arms (3)
Balance training:
EXPERIMENTALIt 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.
STARS
EXPERIMENTALA 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.
Combined Training
EXPERIMENTALEach 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- History of lower extremity surgery
- History of disease that may affect sensorimotor function in the lower extremity
- Musculoskeletal disorders that may affect balance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bahçeşehir Universitylead
- Nevsehir Haci Bektas Veli Universitycollaborator
Study Sites (1)
Bahcesehir University
Beşiktaş, Istanbul, 34353, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Pelin Pişirici, PhD, PT
Bahçeşehir University, Faculty of Health Sciences, Physiotherapy and Rehabilitation Department
- STUDY DIRECTOR
Serkan Uzlaşır, PhD, PT
Nevsehir Haci Bektas Unıversity, Faculty of Sports Sciences, Department of Coaching Education
- PRINCIPAL INVESTIGATOR
Aynur Merve Zümre, PT
Bahçeşehir University, Graduate Education Institute, Physical Therapy and Rehabilitation Program
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, PT, PhD
Study Record Dates
First Submitted
October 26, 2022
First Posted
November 2, 2022
Study Start
November 1, 2022
Primary Completion
January 1, 2023
Study Completion
January 30, 2023
Last Updated
January 31, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share