Trial Outcomes & Findings for Balance Training vs. Balance Training w/ STARS (NCT NCT01790581)
NCT ID: NCT01790581
Last Updated: 2017-07-11
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
Balance at 1-day post intervention
Results posted on
2017-07-11
Participant Flow
Participant milestones
| Measure |
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).
|
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 sessions. Exercises and repetitions 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 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.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Balance Training vs. Balance Training w/ STARS
Baseline characteristics by cohort
| Measure |
Balance Training
n=12 Participants
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).
|
Balance Training w/ STARS
n=12 Participants
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.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21.3 years
STANDARD_DEVIATION 1.7 • n=99 Participants
|
21.8 years
STANDARD_DEVIATION 2.5 • n=107 Participants
|
21.5 years
STANDARD_DEVIATION 2.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=99 Participants
|
12 participants
n=107 Participants
|
24 participants
n=206 Participants
|
|
Foot and Ankle Ability Measure
|
87.1 % of total questionnaire points
STANDARD_DEVIATION 8.1 • n=99 Participants
|
86.5 % of total questionnaire points
STANDARD_DEVIATION 5.6 • n=107 Participants
|
86.8 % of total questionnaire points
STANDARD_DEVIATION 6.9 • n=206 Participants
|
|
Foot and Ankle Ability Measure-Sport
|
66.2 % of total questionnaire points
STANDARD_DEVIATION 12.0 • n=99 Participants
|
72.2 % of total questionnaire points
STANDARD_DEVIATION 10.4 • n=107 Participants
|
68.9 % of total questionnaire points
STANDARD_DEVIATION 11.4 • n=206 Participants
|
|
Star Excursion Balance Test- Anterior Reach
|
68.7 % of leg length
STANDARD_DEVIATION 8.3 • n=99 Participants
|
66.2 % of leg length
STANDARD_DEVIATION 6.9 • n=107 Participants
|
67.5 % of leg length
STANDARD_DEVIATION 7.6 • n=206 Participants
|
|
Star Excursion Balance Test- Posteriomedial Reach
|
79.5 % of leg length
STANDARD_DEVIATION 9.3 • n=99 Participants
|
78.5 % of leg length
STANDARD_DEVIATION 6.7 • n=107 Participants
|
79.0 % of leg length
STANDARD_DEVIATION 8.0 • n=206 Participants
|
|
Star Excursion Balance Test- Posteriolateral Reach
|
75.7 % of leg length
STANDARD_DEVIATION 12.4 • n=99 Participants
|
72.3 % of leg length
STANDARD_DEVIATION 11.3 • n=107 Participants
|
74.0 % of leg length
STANDARD_DEVIATION 11.7 • n=206 Participants
|
PRIMARY outcome
Timeframe: Balance at 1-day post interventionDynamic 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).
Outcome measures
| Measure |
Balance Training
n=12 Participants
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).
|
Balance Training w/ STARS
n=12 Participants
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.
|
|---|---|---|
|
Balance
Star Excursion Balance Test: Posteriomedial Reach
|
87.7 % of leg length
Standard Deviation 9.0
|
85.5 % of leg length
Standard Deviation 8.4
|
|
Balance
Star Excursion Balance Test: Posteriolateral Reach
|
83.9 % of leg length
Standard Deviation 10.8
|
81.0 % of leg length
Standard Deviation 7.44
|
|
Balance
Star Excursion Balance Test: Anterior Reach
|
68.7 % of leg length
Standard Deviation 8.3
|
66.2 % of leg length
Standard Deviation 6.9
|
PRIMARY outcome
Timeframe: Disability to 1-day post intervention2 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.
Outcome measures
| Measure |
Balance Training
n=12 Participants
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).
|
Balance Training w/ STARS
n=12 Participants
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.
|
|---|---|---|
|
Self-assessed Disability
Foot and Ankle Ability Measure- Sport
|
76.4 % of total questionnaire points
Standard Deviation 12.4
|
77.4 % of total questionnaire points
Standard Deviation 9.6
|
|
Self-assessed Disability
Foot and Ankle Ability Measure
|
89.7 % of total questionnaire points
Standard Deviation 5.3
|
88.2 % of total questionnaire points
Standard Deviation 7.9
|
SECONDARY outcome
Timeframe: Change from baseline balance at 1-week post interventionDynamic 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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from baseline disability at 1-week post intervention2 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from baseline disability at 1-month post intervention3 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.
Outcome measures
Outcome data not reported
Adverse Events
Balance Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Balance Training w/ STARS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place