Ankle (Ligaments); Instability (Old Injury)
Conditions
Keywords
Chronic Ankle Instability
Brief summary
Chronic Ankle Instability (CAI) is a health condition that results in repeated ankle sprains and other residual impairments. CAI has been linked to many different causative factors including sensory and motor deficits that affect the global function of the sensorimotor system as well as the patient. Over the past 20 years, strong evidence has been generated to support balance training as an effective intervention strategy in the CAI population. Unfortunately, most investigations have focused solely on maximizing motor output through balance training, while ignoring the full spectrum of sensorimotor dysfunction associated with CAI. There may be advantageous sensory-targeted interventions that augment the effects of balance training and lead to greater enhancements of functional outcomes for CAI. However, this possibility has not been systematically explored. Sensory-targeted ankle rehabilitation strategies (STARS), such as joint mobilization and plantar massage have resulted in improved sensorimotor function in those with CAI. However, only a single STARS (i.e. stochastic resonance) has been investigated in combination with balance training. While the combined effects were greater than those of balance training alone, stochastic resonance requires relatively expensive equipment that is not commercially available. Thus, the purpose of this investigation is to test the hypothesis that combining low cost STARS (e.g. plantar massage and joint mobilizations) with balance training will result in greater sensorimotor and functional improvements in those with CAI than balance training alone.
Interventions
BEHAVIORALBalance Training
This is a 4-week supervised balance training program that has been previously validated in those with CAI by improving subjective and objective measures of function. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. The specific exercises and repetitions that will be performed per training session will include: 1) hop to stabilization (10 repetitions per direction), 2) hop to stabilization and reach (5 repetitions per direction), 3) unanticipated hop to stabilization (3 repetitions), 4) progressive single limb stance balance activities (3 repetitions), and 5) progressive single limb stance activities with eyes closed (3 repetitions).
BEHAVIORALSTARS
The STARS intervention will consist of 4 unique sensory-targeted interventions: calf stretching, ankle joint traction, anterior/posterior ankle joint mobilizations, and plantar massage. These four techniques target 3 types of sensory pathways (musculotendinous, articular, and plantar cutaneous, respectively) and will be applied in the same order for all treatment sessions: 1) 60-second calf stretch, 2) 30-second ankle traction, 3) 30-second mobilization, 4) 2-minute plantar massage, 5) 30-second ankle traction, and 6) 30-second mobilization.
Sponsors
Mid-Atlantic Athletic Trainers' Association
University of North Carolina, Charlotte
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Males and females between the ages of 18 and 35. * A history of at least one episode of giving way within the past 3 months. * Answering 4 or more questions of Yes on the Ankle Instability Instrument (AII). * Score of \<90% on the self-reported Foot and Ankle Ability Measure (FAAM). * Score of \<80% on the FAAM Sport.
Exclusion criteria
* Failing to meet the inclusion criteria. * Known balance and vision problems. * Acute lower extremities and head injuries that occurred \<6 weeks ago. * Chronic musculoskeletal conditions known to affect balance. * A history of ankle surgeries to fix internal derangements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Balance | Balance at 1-day post intervention | Dynamic balance will be assessed with the Star Excursion Balance Test (SEBT). This test requires a person to maintain their balance on a single limb while reaching as far as they can (with their other leg) in 3 different directions (forward, back-left, and back-right). |
| Self-assessed Disability | Disability to 1-day post intervention | 2 questionnaires regarding self-assessed disability during activities of daily living and sport will be completed. The questionnaires will include the Foot and Ankle Ability Measure, and the Foot and Ankle Ability Measure-Sport. The FAAM contains 21 activity related items (max score of 84) while the FAAM-S contains 8 activity related items (max score of 32). Lower percentages (patient's score divided by max score) represent greater disability, and both FAAM and FAAM-S scores have been found to be reliable and precise (r=0.89, SEM= 2.1 and r=0.87, SEM= 4.5, respectively) in people with CAI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Balance | Change from baseline balance at 1-week post intervention | Dynamic balance will be assessed with the Star Excursion Balance Test (SEBT). This test requires a person to maintain their balance on a single limb while reaching as far as they can (with their other leg) in 3 different directions (forward, back-left, and back-right). |
| Self-assessed Disability | Change from baseline disability at 1-week post intervention | 2 questionnaires regarding self-assessed disability during activities of daily living and sport will be completed. The questionnaires will include the Foot and Ankle Ability Measure, and the Foot and Ankle Ability Measure-Sport. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Balance Training Balance Training: This is a 4-week supervised balance training program that has been previously validated in those with CAI by improving subjective and objective measures of function. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. The specific exercises and repetitions that will be performed per training session will include: 1) hop to stabilization (10 repetitions per direction), 2) hop to stabilization and reach (5 repetitions per direction), 3) unanticipated hop to stabilization (3 repetitions), 4) progressive single limb stance balance activities (3 repetitions), and 5) progressive single limb stance activities with eyes closed (3 repetitions). | 12 |
| Balance Training w/ STARS Balance Training: This is a 4-week supervised balance training program. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. Exercises and reps that will be performed per training session will include: 1) hop to stabilization (10 reps per direction), 2) hop to stabilization and reach (5 reps per direction), 3) unanticipated hop to stabilization (3 reps), 4) progressive single limb stance (3 reps), and 5) progressive single limb stance with eyes closed (3 reps).
STARS: The STARS intervention will consist of 4 unique sensory-targeted interventions: calf stretching, ankle joint traction, anterior/posterior ankle joint mobilizations, and plantar massage. These four techniques will be applied in the same order for all sessions: 1) 60-second calf stretch, 2) 30-second ankle traction, 3) 30-second mobilization, 4) 2-minute plantar massage, 5) 30-second ankle traction, and 6) 30-second mobilization. | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | Balance Training | Balance Training w/ STARS | Total |
|---|---|---|---|
| Age, Continuous | 21.3 years STANDARD_DEVIATION 1.7 | 21.8 years STANDARD_DEVIATION 2.5 | 21.5 years STANDARD_DEVIATION 2.1 |
| Foot and Ankle Ability Measure | 87.1 % of total questionnaire points STANDARD_DEVIATION 8.1 | 86.5 % of total questionnaire points STANDARD_DEVIATION 5.6 | 86.8 % of total questionnaire points STANDARD_DEVIATION 6.9 |
| Foot and Ankle Ability Measure-Sport | 66.2 % of total questionnaire points STANDARD_DEVIATION 12 | 72.2 % of total questionnaire points STANDARD_DEVIATION 10.4 | 68.9 % of total questionnaire points STANDARD_DEVIATION 11.4 |
| Region of Enrollment United States | 12 participants | 12 participants | 24 participants |
| Sex: Female, Male Female | 8 Participants | 6 Participants | 14 Participants |
| Sex: Female, Male Male | 4 Participants | 6 Participants | 10 Participants |
| Star Excursion Balance Test- Anterior Reach | 68.7 % of leg length STANDARD_DEVIATION 8.3 | 66.2 % of leg length STANDARD_DEVIATION 6.9 | 67.5 % of leg length STANDARD_DEVIATION 7.6 |
| Star Excursion Balance Test- Posteriolateral Reach | 75.7 % of leg length STANDARD_DEVIATION 12.4 | 72.3 % of leg length STANDARD_DEVIATION 11.3 | 74.0 % of leg length STANDARD_DEVIATION 11.7 |
| Star Excursion Balance Test- Posteriomedial Reach | 79.5 % of leg length STANDARD_DEVIATION 9.3 | 78.5 % of leg length STANDARD_DEVIATION 6.7 | 79.0 % of leg length STANDARD_DEVIATION 8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Balance
Dynamic balance will be assessed with the Star Excursion Balance Test (SEBT). This test requires a person to maintain their balance on a single limb while reaching as far as they can (with their other leg) in 3 different directions (forward, back-left, and back-right).
Time frame: Balance at 1-day post intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balance Training | Balance | Star Excursion Balance Test: Anterior Reach | 68.7 % of leg length | Standard Deviation 8.3 |
| Balance Training | Balance | Star Excursion Balance Test: Posteriomedial Reach | 87.7 % of leg length | Standard Deviation 9 |
| Balance Training | Balance | Star Excursion Balance Test: Posteriolateral Reach | 83.9 % of leg length | Standard Deviation 10.8 |
| Balance Training w/ STARS | Balance | Star Excursion Balance Test: Posteriolateral Reach | 81.0 % of leg length | Standard Deviation 7.44 |
| Balance Training w/ STARS | Balance | Star Excursion Balance Test: Anterior Reach | 66.2 % of leg length | Standard Deviation 6.9 |
| Balance Training w/ STARS | Balance | Star Excursion Balance Test: Posteriomedial Reach | 85.5 % of leg length | Standard Deviation 8.4 |
Comparison: This analysis examined the change in balance scores from baseline to 1-day post intervention for all three reach distances (Anterior, Posteriomedial, Posteriolateral) using a MANOVA.p-value: 0.904MANOVA
Primary
Self-assessed Disability
2 questionnaires regarding self-assessed disability during activities of daily living and sport will be completed. The questionnaires will include the Foot and Ankle Ability Measure, and the Foot and Ankle Ability Measure-Sport. The FAAM contains 21 activity related items (max score of 84) while the FAAM-S contains 8 activity related items (max score of 32). Lower percentages (patient's score divided by max score) represent greater disability, and both FAAM and FAAM-S scores have been found to be reliable and precise (r=0.89, SEM= 2.1 and r=0.87, SEM= 4.5, respectively) in people with CAI.
Time frame: Disability to 1-day post intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balance Training | Self-assessed Disability | Foot and Ankle Ability Measure | 89.7 % of total questionnaire points | Standard Deviation 5.3 |
| Balance Training | Self-assessed Disability | Foot and Ankle Ability Measure- Sport | 76.4 % of total questionnaire points | Standard Deviation 12.4 |
| Balance Training w/ STARS | Self-assessed Disability | Foot and Ankle Ability Measure | 88.2 % of total questionnaire points | Standard Deviation 7.9 |
| Balance Training w/ STARS | Self-assessed Disability | Foot and Ankle Ability Measure- Sport | 77.4 % of total questionnaire points | Standard Deviation 9.6 |
Comparison: This analysis examined the change in disability scores from baseline to 1-day post intervention for both disability scores (FAAM, FAAM-S) using a MANOVA.p-value: 0.5MANOVA
Secondary
Balance
Dynamic balance will be assessed with the Star Excursion Balance Test (SEBT). This test requires a person to maintain their balance on a single limb while reaching as far as they can (with their other leg) in 3 different directions (forward, back-left, and back-right).
Time frame: Change from baseline balance at 1-week post intervention
Secondary
Self-assessed Disability
2 questionnaires regarding self-assessed disability during activities of daily living and sport will be completed. The questionnaires will include the Foot and Ankle Ability Measure, and the Foot and Ankle Ability Measure-Sport.
Time frame: Change from baseline disability at 1-week post intervention
Secondary
Self-assessed Disability
3 questionnaires regarding self-assessed disability during activities of daily living and sport will be completed. The questionnaires will include the Ankle Instability Instrument, the Foot and Ankle Ability Measure, and the Foot and Ankle Ability Measure-Sport.
Time frame: Change from baseline disability at 1-month post intervention