Trial Outcomes & Findings for Bracing and Strengthening for Posterior Tibial Tendon Dysfunction (NCT NCT00756457)
NCT ID: NCT00756457
Last Updated: 2014-07-02
Results Overview
The Foot Function Index (FFI) is a validated disease specific questionnaire that has been used to document outcomes in uncontrolled studies of PTTD. The domains of the 23 item FFI questionnaire include pain, disability, and activity limitations. The scale was originally validated in subjects with foot problems related to rheumatoid arthritis patients, and has subsequently been used to measure outcomes for a variety of foot and ankle problems including plantar fasciitis, diabetes, and PTTD. In clinical trials, the FFI has been used to detect change attributable to orthotics, plantar fasciitis, and brace use in PTTD. The three domains of the FFI include pain (FFI-Pain) range 0 to 90, disability (FFI-Disability) range 0- 90, and activity limitations (FFI-Activity Limitations) range 0 to 50. Each category asks patients to rate items relative to pain with higher scores indicating greater pain. The average of the three scales is the FFI-Total.
COMPLETED
PHASE2
39 participants
Measured at Weeks 1, 6, and 12
2014-07-02
Participant Flow
From 2007 - 2009 88 potential participants were screened from a university medical center.
Participant milestones
| Measure |
Brace & Exercise
Participants in Group A will undergo bracing and perform stretching exercises.
|
Brace
Participants in Group B will undergo bracing and perform stretching and strengthening exercises.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
19
|
|
Overall Study
COMPLETED
|
19
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Brace & Exercise
Participants in Group A will undergo bracing and perform stretching exercises.
|
Brace
Participants in Group B will undergo bracing and perform stretching and strengthening exercises.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
Baseline Characteristics
Bracing and Strengthening for Posterior Tibial Tendon Dysfunction
Baseline characteristics by cohort
| Measure |
Brace & Exercise
n=20 Participants
Participants in Group A will undergo bracing and perform stretching exercises.
|
Brace
n=19 Participants
Participants in Group B will undergo bracing and perform stretching and strengthening exercises.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Continuous
|
57.4 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
58.1 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
57.7 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
19 participants
n=7 Participants
|
39 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at Weeks 1, 6, and 12Population: A power analysis was performed based on previous a previous study. Only the participants that completed the study are included in the analysis. One participant opted to have surgery at 2 weeks from the Brace \& Exercise group. One participant moved overseas and the other resumed cancer treatments bringing the total to 17.
The Foot Function Index (FFI) is a validated disease specific questionnaire that has been used to document outcomes in uncontrolled studies of PTTD. The domains of the 23 item FFI questionnaire include pain, disability, and activity limitations. The scale was originally validated in subjects with foot problems related to rheumatoid arthritis patients, and has subsequently been used to measure outcomes for a variety of foot and ankle problems including plantar fasciitis, diabetes, and PTTD. In clinical trials, the FFI has been used to detect change attributable to orthotics, plantar fasciitis, and brace use in PTTD. The three domains of the FFI include pain (FFI-Pain) range 0 to 90, disability (FFI-Disability) range 0- 90, and activity limitations (FFI-Activity Limitations) range 0 to 50. Each category asks patients to rate items relative to pain with higher scores indicating greater pain. The average of the three scales is the FFI-Total.
Outcome measures
| Measure |
Brace & Exercise (Baseline)
n=19 Participants
This group based on the inclusion exclusion criteria were classified as stage II PTTD.
|
Brace (Baseline)
n=17 Participants
This group based on the inclusion and exclusion criteria was classified as having stage II PTTD.
|
Brace & Exercise (6 Weeks)
n=19 Participants
This group based on the inclusion exclusion criteria were classified as stage II PTTD.
|
Brace (6 Weeks)
n=17 Participants
This group based on the inclusion and exclusion criteria was classified as having stage II PTTD.
|
Brace & Exercise (12 Weeks)
n=19 Participants
This group based on the inclusion exclusion criteria were classified as stage II PTTD.
|
Brace (12 Weeks)
n=17 Participants
This group based on the inclusion and exclusion criteria was classified as having stage II PTTD.
|
|---|---|---|---|---|---|---|
|
Foot Function Index(FFI)
FFI - Activity Limitation (range 0 - 30)
|
16.0 units on a scale
Standard Deviation 11.2
|
12.7 units on a scale
Standard Deviation 12.0
|
8.1 units on a scale
Standard Deviation 8.6
|
8.3 units on a scale
Standard Deviation 8.9
|
9.8 units on a scale
Standard Deviation 12.6
|
6.7 units on a scale
Standard Deviation 7.3
|
|
Foot Function Index(FFI)
FFI - Disability (range 0 - 90)
|
40.0 units on a scale
Standard Deviation 20.4
|
30.6 units on a scale
Standard Deviation 15.4
|
21.3 units on a scale
Standard Deviation 14.6
|
20.8 units on a scale
Standard Deviation 13.1
|
24.4 units on a scale
Standard Deviation 21.6
|
17.8 units on a scale
Standard Deviation 13.5
|
|
Foot Function Index(FFI)
FFI- Pain (range 0 - 50)
|
37.5 units on a scale
Standard Deviation 18.4
|
34.6 units on a scale
Standard Deviation 11.6
|
20.6 units on a scale
Standard Deviation 14.5
|
21.2 units on a scale
Standard Deviation 14.0
|
19.1 units on a scale
Standard Deviation 17.4
|
18.4 units on a scale
Standard Deviation 13.8
|
|
Foot Function Index(FFI)
FFI - Total
|
31.2 units on a scale
Standard Deviation 13.2
|
26.0 units on a scale
Standard Deviation 10.6
|
16.7 units on a scale
Standard Deviation 11.5
|
16.8 units on a scale
Standard Deviation 10.1
|
17.8 units on a scale
Standard Deviation 15.9
|
14.3 units on a scale
Standard Deviation 10.1
|
PRIMARY outcome
Timeframe: Measured at Weeks 1, 6, and 12The Short Musculoskeletal Function Assessment Questionnaire (SMFA) is a 46 item self-report questionnaire consisting of the Dysfunction Index, which has thirty-four items, and the Bother index which has 12 items. The Dysfunction index is used for assessment of patient perceptions of functional performance while the Bother index is used to assess patients' perceptions of the degree patients are bothered in broad areas such as recreation and leisure. The responsiveness to change of the SMFA is 10 points out a range of 100 for each scale (Dysfunction, Mobility, and Bother indexes). The SMFA is also particularly suitable for the current investigation due to the presence of a sub-category of questions from the Dysfunction Index that pertains specifically to mobility (i.e. Mobility Index). Lower scores (lowest = 0) indicate better function, mobility, and that patients are less bothered while higher scores (highest = 100) indicate worse function, mobility and that patients are bothered.
Outcome measures
| Measure |
Brace & Exercise (Baseline)
n=19 Participants
This group based on the inclusion exclusion criteria were classified as stage II PTTD.
|
Brace (Baseline)
n=17 Participants
This group based on the inclusion and exclusion criteria was classified as having stage II PTTD.
|
Brace & Exercise (6 Weeks)
n=19 Participants
This group based on the inclusion exclusion criteria were classified as stage II PTTD.
|
Brace (6 Weeks)
n=17 Participants
This group based on the inclusion and exclusion criteria was classified as having stage II PTTD.
|
Brace & Exercise (12 Weeks)
n=19 Participants
This group based on the inclusion exclusion criteria were classified as stage II PTTD.
|
Brace (12 Weeks)
n=17 Participants
This group based on the inclusion and exclusion criteria was classified as having stage II PTTD.
|
|---|---|---|---|---|---|---|
|
Short Musculoskeletal Functional Assessment
Dysfunction (Range 0- 100)
|
22.2 score
Standard Deviation 12.3
|
16.6 score
Standard Deviation 9.0
|
13.0 score
Standard Deviation 9.1
|
12.9 score
Standard Deviation 7.2
|
14.5 score
Standard Deviation 9.1
|
11.7 score
Standard Deviation 6.3
|
|
Short Musculoskeletal Functional Assessment
Mobility (Range 0 - 100)
|
26.6 score
Standard Deviation 14.2
|
22.1 score
Standard Deviation 11.6
|
15.2 score
Standard Deviation 10.6
|
18.4 score
Standard Deviation 10.6
|
17.0 score
Standard Deviation 10.7
|
15.5 score
Standard Deviation 8.2
|
|
Short Musculoskeletal Functional Assessment
Bother (Range 0 - 100)
|
25.8 score
Standard Deviation 20.1
|
22.8 score
Standard Deviation 16.4
|
15.1 score
Standard Deviation 13.9
|
13.7 score
Standard Deviation 9.2
|
16.4 score
Standard Deviation 18.9
|
11.8 score
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: Measured at Weeks 1,6 and 12A 3 dimensional foot kinematic model including the tibia, calcaneus (hindfoot), 1st metatarsal, 2-4th metatarsals and hallux was used to measure foot movement. Six infrared cameras (Optotrak Motion Analysis System, Northern Digital Inc, CAN), synchronized with force plate data (Model 9286, Kistler, Switzerland), were used to collect kinematics (60 Hz) and force (1000 Hz) data with the Motion Monitor software Version 7.24 (Motion Monitor, Innsport Training Inc, USA). Anatomically based coordinate systems were established for each segment using digitized boney landmarks consistent with a previous study. Kinematic data were smoothed using a 4th order, zero phase lag, Butterworth filter with a cut off frequency of 6 Hz. To calculate relative joint angles a Cardan angle Z-X-Y sequence of rotations was used as suggested by Cole et al. The range of possible values varies for each individual and each joint.
Outcome measures
| Measure |
Brace & Exercise (Baseline)
n=19 Participants
This group based on the inclusion exclusion criteria were classified as stage II PTTD.
|
Brace (Baseline)
n=17 Participants
This group based on the inclusion and exclusion criteria was classified as having stage II PTTD.
|
Brace & Exercise (6 Weeks)
n=19 Participants
This group based on the inclusion exclusion criteria were classified as stage II PTTD.
|
Brace (6 Weeks)
n=17 Participants
This group based on the inclusion and exclusion criteria was classified as having stage II PTTD.
|
Brace & Exercise (12 Weeks)
n=19 Participants
This group based on the inclusion exclusion criteria were classified as stage II PTTD.
|
Brace (12 Weeks)
n=17 Participants
This group based on the inclusion and exclusion criteria was classified as having stage II PTTD.
|
|---|---|---|---|---|---|---|
|
Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)
Hindfoot In(+)/Ev(-) (5% Stance)
|
-8.6 Degrees
Standard Deviation 3.2
|
-8.8 Degrees
Standard Deviation 3.8
|
-8.4 Degrees
Standard Deviation 3.1
|
-8.2 Degrees
Standard Deviation 3.7
|
-8.7 Degrees
Standard Deviation 2.8
|
-8.8 Degrees
Standard Deviation 4.0
|
|
Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)
Hindfoot In(+)/Ev(-) (39% Stance)
|
-10.8 Degrees
Standard Deviation 2.4
|
-10.6 Degrees
Standard Deviation 3.0
|
-11.2 Degrees
Standard Deviation 2.9
|
-10.2 Degrees
Standard Deviation 3.6
|
-10.5 Degrees
Standard Deviation 3.1
|
-10.6 Degrees
Standard Deviation 3.4
|
|
Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)
Hindfoot In(+)/Ev(-) (84% Stance)
|
-4.9 Degrees
Standard Deviation 3.7
|
-4.2 Degrees
Standard Deviation 3.5
|
-5.5 Degrees
Standard Deviation 3.1
|
-4.6 Degrees
Standard Deviation 3.6
|
-4.5 Degrees
Standard Deviation 4.4
|
-4.5 Degrees
Standard Deviation 3.9
|
|
Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)
Hindfoot Df(+)/Pf(-) (5% Stance)
|
-8.8 Degrees
Standard Deviation 3.6
|
-7.5 Degrees
Standard Deviation 3.3
|
-3.4 Degrees
Standard Deviation 4.6
|
-0.4 Degrees
Standard Deviation 5.6
|
-4.0 Degrees
Standard Deviation 4.8
|
-1.0 Degrees
Standard Deviation 6.3
|
|
Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)
Hindfoot Df(+)/Pf(-) (39% Stance)
|
0.2 Degrees
Standard Deviation 2.9
|
2.4 Degrees
Standard Deviation 3.8
|
6.2 Degrees
Standard Deviation 3.7
|
9.7 Degrees
Standard Deviation 4.8
|
6.3 Degrees
Standard Deviation 4.3
|
9.1 Degrees
Standard Deviation 6.4
|
|
Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)
Hindfoot Df(+)/Pf(-) (84% Stance)
|
5.7 Degrees
Standard Deviation 4.3
|
6.8 Degrees
Standard Deviation 4.6
|
11.9 Degrees
Standard Deviation 5.4
|
14.0 Degrees
Standard Deviation 7.3
|
11.8 Degrees
Standard Deviation 4.6
|
13.6 Degrees
Standard Deviation 7.7
|
|
Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)
1st Met Ad(+)/Ab(-) (5% Stance)
|
-6.5 Degrees
Standard Deviation 3.2
|
-7.2 Degrees
Standard Deviation 3.2
|
-6.3 Degrees
Standard Deviation 3.2
|
-7.4 Degrees
Standard Deviation 2.6
|
-6.4 Degrees
Standard Deviation 2.9
|
-6.7 Degrees
Standard Deviation 3.2
|
|
Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)
1st Met Ad(+)/Ab(-) (39% Stance)
|
-5.2 Degrees
Standard Deviation 3.3
|
-6.9 Degrees
Standard Deviation 2.5
|
-5.1 Degrees
Standard Deviation 3.0
|
-6.9 Degrees
Standard Deviation 2.3
|
-5.2 Degrees
Standard Deviation 2.6
|
-6.4 Degrees
Standard Deviation 2.9
|
|
Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)
1st Met Ad(+)/Ab(-) (84% Stance)
|
-6.7 Degrees
Standard Deviation 4.9
|
-7.4 Degrees
Standard Deviation 4.2
|
-6.6 Degrees
Standard Deviation 5.0
|
-7.5 Degrees
Standard Deviation 4.0
|
-7.5 Degrees
Standard Deviation 4.5
|
-7.4 Degrees
Standard Deviation 4.3
|
|
Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)
1st Met Df(+)/Pf(-) (5% Stance)
|
11.2 Degrees
Standard Deviation 6.5
|
8.2 Degrees
Standard Deviation 6.1
|
11.4 Degrees
Standard Deviation 6.5
|
8.5 Degrees
Standard Deviation 7.0
|
12.6 Degrees
Standard Deviation 7.1
|
9.1 Degrees
Standard Deviation 6.4
|
|
Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)
1st Met Df(+)/Pf(-) (39% Stance)
|
14.8 Degrees
Standard Deviation 6.1
|
11.7 Degrees
Standard Deviation 5.7
|
14.3 Degrees
Standard Deviation 5.9
|
11.9 Degrees
Standard Deviation 6.3
|
15.6 Degrees
Standard Deviation 6.3
|
12.6 Degrees
Standard Deviation 5.5
|
|
Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)
1st Met Df(+)/Pf(-) (84% Stance)
|
14.2 Degrees
Standard Deviation 8.6
|
12.6 Degrees
Standard Deviation 6.9
|
14.2 Degrees
Standard Deviation 7.7
|
12.4 Degrees
Standard Deviation 8.3
|
14.8 Degrees
Standard Deviation 8.3
|
13.3 Degrees
Standard Deviation 7.3
|
SECONDARY outcome
Timeframe: Measured at Weeks 1, 6, and 12A force transducer (Model SML-200, Interface, Scottsdale, AZ) was connected in series with a resistance plate and oscilloscope (TDS 410A, Tektronix, Beaverton, OR) to display force readings. Participants were seated with their leg in an an air stirrup brace (Aircast, Inc.) mounted on uprights. The air stirrup brace was adjusted so the heel was approximately 10 cm above the resistance plate, resulting in 30 to 45 degrees of ankle plantar flexion depending on foot length. The resistance plate was mounted on ball bearing tracks in the medial/lateral direction and moleskin was used to fit to the general shape of the medial forefoot. The result was that participants could exert maximum effort against the resistance plate (medial direction) with little discomfort. This testing position essentially replicates the manual muscle test position for the posterior tibialis muscle. Force in Newtons was then divided by body mass in kilograms to calculate normalized strength (N/Kg).
Outcome measures
| Measure |
Brace & Exercise (Baseline)
n=19 Participants
This group based on the inclusion exclusion criteria were classified as stage II PTTD.
|
Brace (Baseline)
n=17 Participants
This group based on the inclusion and exclusion criteria was classified as having stage II PTTD.
|
Brace & Exercise (6 Weeks)
n=19 Participants
This group based on the inclusion exclusion criteria were classified as stage II PTTD.
|
Brace (6 Weeks)
n=17 Participants
This group based on the inclusion and exclusion criteria was classified as having stage II PTTD.
|
Brace & Exercise (12 Weeks)
n=19 Participants
This group based on the inclusion exclusion criteria were classified as stage II PTTD.
|
Brace (12 Weeks)
n=17 Participants
This group based on the inclusion and exclusion criteria was classified as having stage II PTTD.
|
|---|---|---|---|---|---|---|
|
Foot Strength
Involved Subtalar Inversion Strength
|
0.70 N/kg
Standard Deviation 0.20
|
0.79 N/kg
Standard Deviation 0.25
|
0.77 N/kg
Standard Deviation 0.21
|
0.86 N/kg
Standard Deviation 0.29
|
0.78 N/kg
Standard Deviation 0.21
|
0.82 N/kg
Standard Deviation 0.25
|
|
Foot Strength
Uninvolved Subtalar Inversion Strength
|
0.81 N/kg
Standard Deviation 0.16
|
0.94 N/kg
Standard Deviation 0.25
|
0.84 N/kg
Standard Deviation 0.18
|
0.99 N/kg
Standard Deviation 0.22
|
0.85 N/kg
Standard Deviation 0.13
|
0.99 N/kg
Standard Deviation 0.23
|
Adverse Events
Brace & Exercise
Brace
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