Skip to content

Bracing and Strengthening for Posterior Tibial Tendon Dysfunction

The Effect of Bracing and Strengthening Exercises on Posterior Tibial Tendon Dysfunction

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00756457
Enrollment
39
Registered
2008-09-22
Start date
2007-07-31
Completion date
2008-09-30
Last updated
2014-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posterior Tibial Tendon Dysfunction

Keywords

PTTD, Tendinopathy, Tendon Injuries, Muscular Diseases, Foot Diseases

Brief summary

Posterior tibial tendon dysfunction (PTTD) is a problem with the tendon connecting one of the lower leg muscles to the foot bone. PTTD can cause pain, swelling, and a flattened foot and may require surgery if left untreated. Normal treatment for PTTD includes physical therapy exercise. In treating similar conditions in the lower leg, exercises that are active, like strengthening, seem to have better results than exercises that are passive, like stretching. This study will determine whether adding strengthening exercises to a normal PTTD treatment that includes wearing a brace and stretching is more beneficial than just wearing a brace and stretching.

Detailed description

Posterior tibial tendon dysfunction (PTTD) involves inflammation, overstretching, or both of the posterial tibial tendon, which connects the tibialis posterior muscle to the bones in the foot. PTTD can cause pain in the inner ankle and development of a flat foot. Without treatment, correction of PTTD may require surgery. Standard interventions that may prevent the need for surgery include orthotic devices, bracing, and physical therapy, among other possibilities. Within physical therapy, foot exercises can be either active-as in the case of strengthening exercises-or passive-as in the case of stretching exercises. Evidence from clinical treatment of similar conditions suggests that active exercises are more effective than passive exercises in leading to recovery. This study will determine whether adding strengthening exercises to a normal intervention of bracing and stretching is more effective in improving a range of symptoms in stage II PTTD patients than using only bracing and stretching exercises. Participants with Stage II PTTD will be recruited and placed in one of two groups for the duration of the 12-week study. The first group will undergo regular bracing and perform stretching exercises. The second group will undergo regular bracing and perform stretching and strengthening exercises. Braces, worn during weight-bearing tasks throughout the study, will include ankle stirrup support and medial longitudinal arch support. Strengthening exercises, which will be preceded by a warm-up of the posterior tibialis muscle, will include bilateral heel raises, foot adduction and rear foot inversion with thera-tubing, and unilateral heel raises. Frequency of exercise and number of repetitions will increase over the course of the study until participants are performing 3 sets of 30 repetitions 2 times per day. Assessments, which will occur at study entry, after 6 weeks, and after 12 weeks, will include foot range of motion, length of the posterior tibial muscle, and self-assessments of function.

Interventions

DEVICEBracing

Participants will wear a brace that includes ankle stirrup support and medial longitudinal arch support. The brace will be worn during weight-bearing tasks throughout the 12-week study.

Participants performed strengthening exercises progressively longer each time for up to 3 sets of 30 repetitions twice daily by the third visit. Exercises included bilateral heel raises, foot adduction/rear foot inversion with thera-tubing, and unilateral heel raises. Participants increased resistance by using thera-bands with higher levels of resistance over the 12 week period. The amount of resistance was progressed according to patient tolerance at each visit. Strengthening exercises were preceded by the control stretching exercises which constituted a warm up.

OTHERStretching exercises

Subjects were provided with written descriptions and pictures demonstrating 2 range-of-motion exercises which included a wall calf stretch, and a supine ankle active range-of-motion exercise. Subjects were instructed to perform 3 sets of the stretching exercises, 2 times a day, similar to the intervention group. Each stretching exercise was performed twice and held for 30 seconds.

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
CollaboratorNIH
Ithaca College
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Diagnosis of Stage II PTTD disorder * Flexible flat foot deformity * Palpable tenderness of posterior tibial tendon * Swelling of the posterior tibial tendon sheath * Pain during single limb heel rise * Abnormal rear foot valgus * Abnormal fore foot abduction as compared to contralateral side

Exclusion criteria

* Unable to walk for more than 15 meters * Comorbidity within the foot * Loss of protective sensation of the foot, as indicated by Semmes-Weinstein monofilament test of 5.07 * Inflammatory arthropathies * Score greater than 23 on Mini Mental Status exam * Arch index of less than 0.255 * Inability to assume a subtalar neutral posture * PTTD in both feet

Design outcomes

Primary

MeasureTime frameDescription
Foot Function Index(FFI)Measured at Weeks 1, 6, and 12The 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.
Short Musculoskeletal Functional AssessmentMeasured 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.

Secondary

MeasureTime frameDescription
Foot StrengthMeasured 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).
Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)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.

Countries

United States

Participant flow

Recruitment details

From 2007 - 2009 88 potential participants were screened from a university medical center.

Participants by arm

ArmCount
Brace & Exercise
Participants in Group A will undergo bracing and perform stretching exercises.
20
Brace
Participants in Group B will undergo bracing and perform stretching and strengthening exercises.
19
Total39

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up12

Baseline characteristics

CharacteristicBraceBrace & ExerciseTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
5 Participants7 Participants12 Participants
Age, Categorical
Between 18 and 65 years
14 Participants13 Participants27 Participants
Age, Continuous58.1 years
STANDARD_DEVIATION 9.3
57.4 years
STANDARD_DEVIATION 11.9
57.7 years
STANDARD_DEVIATION 10.6
Region of Enrollment
United States
19 participants20 participants39 participants
Sex: Female, Male
Female
15 Participants16 Participants31 Participants
Sex: Female, Male
Male
4 Participants4 Participants8 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 200 / 19
serious
Total, serious adverse events
0 / 200 / 19

Outcome results

Primary

Foot Function Index(FFI)

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.

Time frame: Measured at Weeks 1, 6, and 12

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Brace & Exercise (Baseline)Foot Function Index(FFI)FFI - Activity Limitation (range 0 - 30)16.0 units on a scaleStandard Deviation 11.2
Brace & Exercise (Baseline)Foot Function Index(FFI)FFI - Disability (range 0 - 90)40.0 units on a scaleStandard Deviation 20.4
Brace & Exercise (Baseline)Foot Function Index(FFI)FFI- Pain (range 0 - 50)37.5 units on a scaleStandard Deviation 18.4
Brace & Exercise (Baseline)Foot Function Index(FFI)FFI - Total31.2 units on a scaleStandard Deviation 13.2
Brace (Baseline)Foot Function Index(FFI)FFI- Pain (range 0 - 50)34.6 units on a scaleStandard Deviation 11.6
Brace (Baseline)Foot Function Index(FFI)FFI - Disability (range 0 - 90)30.6 units on a scaleStandard Deviation 15.4
Brace (Baseline)Foot Function Index(FFI)FFI - Activity Limitation (range 0 - 30)12.7 units on a scaleStandard Deviation 12
Brace (Baseline)Foot Function Index(FFI)FFI - Total26.0 units on a scaleStandard Deviation 10.6
Brace & Exercise (6 Weeks)Foot Function Index(FFI)FFI - Total16.7 units on a scaleStandard Deviation 11.5
Brace & Exercise (6 Weeks)Foot Function Index(FFI)FFI- Pain (range 0 - 50)20.6 units on a scaleStandard Deviation 14.5
Brace & Exercise (6 Weeks)Foot Function Index(FFI)FFI - Disability (range 0 - 90)21.3 units on a scaleStandard Deviation 14.6
Brace & Exercise (6 Weeks)Foot Function Index(FFI)FFI - Activity Limitation (range 0 - 30)8.1 units on a scaleStandard Deviation 8.6
Brace (6 Weeks)Foot Function Index(FFI)FFI - Activity Limitation (range 0 - 30)8.3 units on a scaleStandard Deviation 8.9
Brace (6 Weeks)Foot Function Index(FFI)FFI - Total16.8 units on a scaleStandard Deviation 10.1
Brace (6 Weeks)Foot Function Index(FFI)FFI - Disability (range 0 - 90)20.8 units on a scaleStandard Deviation 13.1
Brace (6 Weeks)Foot Function Index(FFI)FFI- Pain (range 0 - 50)21.2 units on a scaleStandard Deviation 14
Brace & Exercise (12 Weeks)Foot Function Index(FFI)FFI- Pain (range 0 - 50)19.1 units on a scaleStandard Deviation 17.4
Brace & Exercise (12 Weeks)Foot Function Index(FFI)FFI - Total17.8 units on a scaleStandard Deviation 15.9
Brace & Exercise (12 Weeks)Foot Function Index(FFI)FFI - Disability (range 0 - 90)24.4 units on a scaleStandard Deviation 21.6
Brace & Exercise (12 Weeks)Foot Function Index(FFI)FFI - Activity Limitation (range 0 - 30)9.8 units on a scaleStandard Deviation 12.6
Brace (12 Weeks)Foot Function Index(FFI)FFI - Disability (range 0 - 90)17.8 units on a scaleStandard Deviation 13.5
Brace (12 Weeks)Foot Function Index(FFI)FFI- Pain (range 0 - 50)18.4 units on a scaleStandard Deviation 13.8
Brace (12 Weeks)Foot Function Index(FFI)FFI - Total14.3 units on a scaleStandard Deviation 10.1
Brace (12 Weeks)Foot Function Index(FFI)FFI - Activity Limitation (range 0 - 30)6.7 units on a scaleStandard Deviation 7.3
Primary

Short Musculoskeletal Functional Assessment

The 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.

Time frame: Measured at Weeks 1, 6, and 12

ArmMeasureGroupValue (MEAN)Dispersion
Brace & Exercise (Baseline)Short Musculoskeletal Functional AssessmentMobility (Range 0 - 100)26.6 scoreStandard Deviation 14.2
Brace & Exercise (Baseline)Short Musculoskeletal Functional AssessmentDysfunction (Range 0- 100)22.2 scoreStandard Deviation 12.3
Brace & Exercise (Baseline)Short Musculoskeletal Functional AssessmentBother (Range 0 - 100)25.8 scoreStandard Deviation 20.1
Brace (Baseline)Short Musculoskeletal Functional AssessmentMobility (Range 0 - 100)22.1 scoreStandard Deviation 11.6
Brace (Baseline)Short Musculoskeletal Functional AssessmentDysfunction (Range 0- 100)16.6 scoreStandard Deviation 9
Brace (Baseline)Short Musculoskeletal Functional AssessmentBother (Range 0 - 100)22.8 scoreStandard Deviation 16.4
Brace & Exercise (6 Weeks)Short Musculoskeletal Functional AssessmentMobility (Range 0 - 100)15.2 scoreStandard Deviation 10.6
Brace & Exercise (6 Weeks)Short Musculoskeletal Functional AssessmentDysfunction (Range 0- 100)13.0 scoreStandard Deviation 9.1
Brace & Exercise (6 Weeks)Short Musculoskeletal Functional AssessmentBother (Range 0 - 100)15.1 scoreStandard Deviation 13.9
Brace (6 Weeks)Short Musculoskeletal Functional AssessmentMobility (Range 0 - 100)18.4 scoreStandard Deviation 10.6
Brace (6 Weeks)Short Musculoskeletal Functional AssessmentDysfunction (Range 0- 100)12.9 scoreStandard Deviation 7.2
Brace (6 Weeks)Short Musculoskeletal Functional AssessmentBother (Range 0 - 100)13.7 scoreStandard Deviation 9.2
Brace & Exercise (12 Weeks)Short Musculoskeletal Functional AssessmentMobility (Range 0 - 100)17.0 scoreStandard Deviation 10.7
Brace & Exercise (12 Weeks)Short Musculoskeletal Functional AssessmentDysfunction (Range 0- 100)14.5 scoreStandard Deviation 9.1
Brace & Exercise (12 Weeks)Short Musculoskeletal Functional AssessmentBother (Range 0 - 100)16.4 scoreStandard Deviation 18.9
Brace (12 Weeks)Short Musculoskeletal Functional AssessmentDysfunction (Range 0- 100)11.7 scoreStandard Deviation 6.3
Brace (12 Weeks)Short Musculoskeletal Functional AssessmentBother (Range 0 - 100)11.8 scoreStandard Deviation 6.4
Brace (12 Weeks)Short Musculoskeletal Functional AssessmentMobility (Range 0 - 100)15.5 scoreStandard Deviation 8.2
Secondary

Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)

A 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.

Time frame: Measured at Weeks 1,6 and 12

ArmMeasureGroupValue (MEAN)Dispersion
Brace & Exercise (Baseline)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)1st Met Ad(+)/Ab(-) (84% Stance)-6.7 DegreesStandard Deviation 4.9
Brace & Exercise (Baseline)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)Hindfoot In(+)/Ev(-) (5% Stance)-8.6 DegreesStandard Deviation 3.2
Brace & Exercise (Baseline)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)1st Met Ad(+)/Ab(-) (39% Stance)-5.2 DegreesStandard Deviation 3.3
Brace & Exercise (Baseline)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)1st Met Df(+)/Pf(-) (84% Stance)14.2 DegreesStandard Deviation 8.6
Brace & Exercise (Baseline)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)Hindfoot In(+)/Ev(-) (84% Stance)-4.9 DegreesStandard Deviation 3.7
Brace & Exercise (Baseline)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)1st Met Df(+)/Pf(-) (39% Stance)14.8 DegreesStandard Deviation 6.1
Brace & Exercise (Baseline)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)Hindfoot Df(+)/Pf(-) (5% Stance)-8.8 DegreesStandard Deviation 3.6
Brace & Exercise (Baseline)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)Hindfoot Df(+)/Pf(-) (39% Stance)0.2 DegreesStandard Deviation 2.9
Brace & Exercise (Baseline)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)1st Met Df(+)/Pf(-) (5% Stance)11.2 DegreesStandard Deviation 6.5
Brace & Exercise (Baseline)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)Hindfoot Df(+)/Pf(-) (84% Stance)5.7 DegreesStandard Deviation 4.3
Brace & Exercise (Baseline)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)Hindfoot In(+)/Ev(-) (39% Stance)-10.8 DegreesStandard Deviation 2.4
Brace & Exercise (Baseline)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)1st Met Ad(+)/Ab(-) (5% Stance)-6.5 DegreesStandard Deviation 3.2
Brace (Baseline)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)Hindfoot Df(+)/Pf(-) (84% Stance)6.8 DegreesStandard Deviation 4.6
Brace (Baseline)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)1st Met Ad(+)/Ab(-) (5% Stance)-7.2 DegreesStandard Deviation 3.2
Brace (Baseline)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)1st Met Ad(+)/Ab(-) (84% Stance)-7.4 DegreesStandard Deviation 4.2
Brace (Baseline)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)Hindfoot In(+)/Ev(-) (39% Stance)-10.6 DegreesStandard Deviation 3
Brace (Baseline)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)Hindfoot Df(+)/Pf(-) (39% Stance)2.4 DegreesStandard Deviation 3.8
Brace (Baseline)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)Hindfoot Df(+)/Pf(-) (5% Stance)-7.5 DegreesStandard Deviation 3.3
Brace (Baseline)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)Hindfoot In(+)/Ev(-) (5% Stance)-8.8 DegreesStandard Deviation 3.8
Brace (Baseline)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)1st Met Ad(+)/Ab(-) (39% Stance)-6.9 DegreesStandard Deviation 2.5
Brace (Baseline)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)1st Met Df(+)/Pf(-) (39% Stance)11.7 DegreesStandard Deviation 5.7
Brace (Baseline)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)Hindfoot In(+)/Ev(-) (84% Stance)-4.2 DegreesStandard Deviation 3.5
Brace (Baseline)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)1st Met Df(+)/Pf(-) (84% Stance)12.6 DegreesStandard Deviation 6.9
Brace (Baseline)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)1st Met Df(+)/Pf(-) (5% Stance)8.2 DegreesStandard Deviation 6.1
Brace & Exercise (6 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)1st Met Df(+)/Pf(-) (39% Stance)14.3 DegreesStandard Deviation 5.9
Brace & Exercise (6 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)Hindfoot In(+)/Ev(-) (84% Stance)-5.5 DegreesStandard Deviation 3.1
Brace & Exercise (6 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)1st Met Ad(+)/Ab(-) (84% Stance)-6.6 DegreesStandard Deviation 5
Brace & Exercise (6 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)Hindfoot Df(+)/Pf(-) (5% Stance)-3.4 DegreesStandard Deviation 4.6
Brace & Exercise (6 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)1st Met Df(+)/Pf(-) (84% Stance)14.2 DegreesStandard Deviation 7.7
Brace & Exercise (6 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)1st Met Df(+)/Pf(-) (5% Stance)11.4 DegreesStandard Deviation 6.5
Brace & Exercise (6 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)1st Met Ad(+)/Ab(-) (5% Stance)-6.3 DegreesStandard Deviation 3.2
Brace & Exercise (6 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)1st Met Ad(+)/Ab(-) (39% Stance)-5.1 DegreesStandard Deviation 3
Brace & Exercise (6 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)Hindfoot Df(+)/Pf(-) (39% Stance)6.2 DegreesStandard Deviation 3.7
Brace & Exercise (6 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)Hindfoot In(+)/Ev(-) (39% Stance)-11.2 DegreesStandard Deviation 2.9
Brace & Exercise (6 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)Hindfoot In(+)/Ev(-) (5% Stance)-8.4 DegreesStandard Deviation 3.1
Brace & Exercise (6 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)Hindfoot Df(+)/Pf(-) (84% Stance)11.9 DegreesStandard Deviation 5.4
Brace (6 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)1st Met Ad(+)/Ab(-) (39% Stance)-6.9 DegreesStandard Deviation 2.3
Brace (6 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)Hindfoot In(+)/Ev(-) (5% Stance)-8.2 DegreesStandard Deviation 3.7
Brace (6 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)Hindfoot In(+)/Ev(-) (39% Stance)-10.2 DegreesStandard Deviation 3.6
Brace (6 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)Hindfoot In(+)/Ev(-) (84% Stance)-4.6 DegreesStandard Deviation 3.6
Brace (6 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)Hindfoot Df(+)/Pf(-) (5% Stance)-0.4 DegreesStandard Deviation 5.6
Brace (6 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)Hindfoot Df(+)/Pf(-) (39% Stance)9.7 DegreesStandard Deviation 4.8
Brace (6 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)Hindfoot Df(+)/Pf(-) (84% Stance)14.0 DegreesStandard Deviation 7.3
Brace (6 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)1st Met Ad(+)/Ab(-) (5% Stance)-7.4 DegreesStandard Deviation 2.6
Brace (6 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)1st Met Ad(+)/Ab(-) (84% Stance)-7.5 DegreesStandard Deviation 4
Brace (6 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)1st Met Df(+)/Pf(-) (5% Stance)8.5 DegreesStandard Deviation 7
Brace (6 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)1st Met Df(+)/Pf(-) (39% Stance)11.9 DegreesStandard Deviation 6.3
Brace (6 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)1st Met Df(+)/Pf(-) (84% Stance)12.4 DegreesStandard Deviation 8.3
Brace & Exercise (12 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)Hindfoot Df(+)/Pf(-) (39% Stance)6.3 DegreesStandard Deviation 4.3
Brace & Exercise (12 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)Hindfoot In(+)/Ev(-) (84% Stance)-4.5 DegreesStandard Deviation 4.4
Brace & Exercise (12 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)Hindfoot In(+)/Ev(-) (5% Stance)-8.7 DegreesStandard Deviation 2.8
Brace & Exercise (12 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)1st Met Df(+)/Pf(-) (84% Stance)14.8 DegreesStandard Deviation 8.3
Brace & Exercise (12 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)1st Met Df(+)/Pf(-) (39% Stance)15.6 DegreesStandard Deviation 6.3
Brace & Exercise (12 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)Hindfoot Df(+)/Pf(-) (5% Stance)-4.0 DegreesStandard Deviation 4.8
Brace & Exercise (12 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)Hindfoot In(+)/Ev(-) (39% Stance)-10.5 DegreesStandard Deviation 3.1
Brace & Exercise (12 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)1st Met Ad(+)/Ab(-) (84% Stance)-7.5 DegreesStandard Deviation 4.5
Brace & Exercise (12 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)1st Met Df(+)/Pf(-) (5% Stance)12.6 DegreesStandard Deviation 7.1
Brace & Exercise (12 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)1st Met Ad(+)/Ab(-) (5% Stance)-6.4 DegreesStandard Deviation 2.9
Brace & Exercise (12 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)1st Met Ad(+)/Ab(-) (39% Stance)-5.2 DegreesStandard Deviation 2.6
Brace & Exercise (12 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)Hindfoot Df(+)/Pf(-) (84% Stance)11.8 DegreesStandard Deviation 4.6
Brace (12 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)1st Met Ad(+)/Ab(-) (39% Stance)-6.4 DegreesStandard Deviation 2.9
Brace (12 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)Hindfoot Df(+)/Pf(-) (39% Stance)9.1 DegreesStandard Deviation 6.4
Brace (12 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)1st Met Ad(+)/Ab(-) (84% Stance)-7.4 DegreesStandard Deviation 4.3
Brace (12 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)Hindfoot Df(+)/Pf(-) (5% Stance)-1.0 DegreesStandard Deviation 6.3
Brace (12 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)1st Met Df(+)/Pf(-) (84% Stance)13.3 DegreesStandard Deviation 7.3
Brace (12 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)1st Met Df(+)/Pf(-) (5% Stance)9.1 DegreesStandard Deviation 6.4
Brace (12 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)Hindfoot In(+)/Ev(-) (84% Stance)-4.5 DegreesStandard Deviation 3.9
Brace (12 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)Hindfoot In(+)/Ev(-) (39% Stance)-10.6 DegreesStandard Deviation 3.4
Brace (12 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)1st Met Df(+)/Pf(-) (39% Stance)12.6 DegreesStandard Deviation 5.5
Brace (12 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)Hindfoot In(+)/Ev(-) (5% Stance)-8.8 DegreesStandard Deviation 4
Brace (12 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)1st Met Ad(+)/Ab(-) (5% Stance)-6.7 DegreesStandard Deviation 3.2
Brace (12 Weeks)Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)Hindfoot Df(+)/Pf(-) (84% Stance)13.6 DegreesStandard Deviation 7.7
Secondary

Foot Strength

A 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).

Time frame: Measured at Weeks 1, 6, and 12

ArmMeasureGroupValue (MEAN)Dispersion
Brace & Exercise (Baseline)Foot StrengthUninvolved Subtalar Inversion Strength0.81 N/kgStandard Deviation 0.16
Brace & Exercise (Baseline)Foot StrengthInvolved Subtalar Inversion Strength0.70 N/kgStandard Deviation 0.2
Brace (Baseline)Foot StrengthUninvolved Subtalar Inversion Strength0.94 N/kgStandard Deviation 0.25
Brace (Baseline)Foot StrengthInvolved Subtalar Inversion Strength0.79 N/kgStandard Deviation 0.25
Brace & Exercise (6 Weeks)Foot StrengthInvolved Subtalar Inversion Strength0.77 N/kgStandard Deviation 0.21
Brace & Exercise (6 Weeks)Foot StrengthUninvolved Subtalar Inversion Strength0.84 N/kgStandard Deviation 0.18
Brace (6 Weeks)Foot StrengthInvolved Subtalar Inversion Strength0.86 N/kgStandard Deviation 0.29
Brace (6 Weeks)Foot StrengthUninvolved Subtalar Inversion Strength0.99 N/kgStandard Deviation 0.22
Brace & Exercise (12 Weeks)Foot StrengthInvolved Subtalar Inversion Strength0.78 N/kgStandard Deviation 0.21
Brace & Exercise (12 Weeks)Foot StrengthUninvolved Subtalar Inversion Strength0.85 N/kgStandard Deviation 0.13
Brace (12 Weeks)Foot StrengthUninvolved Subtalar Inversion Strength0.99 N/kgStandard Deviation 0.23
Brace (12 Weeks)Foot StrengthInvolved Subtalar Inversion Strength0.82 N/kgStandard Deviation 0.25

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026