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Plantar Heel Pain: Multisegment Foot Motion and Muscle Function, FFI Translation, and Evaluation of Treatments

Plantar Heel Pain: Multisegmental Foot Motion and Muscle Function, FFI Translation, and Evaluation of Physical Therapy Treatments

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03161314
Enrollment
84
Registered
2017-05-19
Start date
2017-08-01
Completion date
2019-03-01
Last updated
2025-07-04

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

Conditions

Plantar Fasciitis

Keywords

plantar fasciitis, multisegment foot motion, gait, physical therapy, strengthening, stretching, exercise, translation, plantar heel pain

Brief summary

Plantar fasciitis (PF) is a prevalent musculoskeletal condition of plantar heel pain (PHP) that leads to pain, functional limitations, and reduced quality of life, especially among active adults aged 25 to 65. Understanding the biomechanical alterations in foot motion among individuals with PF is essential to inform targeted treatment strategies and prevent symptom chronicity. However, research exploring detailed multi-segment foot motion changes in this population remains limited. Assessing foot function is a key component in understanding symptom development and treatment outcomes. The Foot Function Index (FFI) is an internationally recognized, reliable, and valid questionnaire used to measure foot pain and disability. To facilitate its use in Thai populations and enable cross-cultural comparisons, it is crucial to translate and validate the FFI into Thai. Although exercise interventions such as strengthening and stretching are widely used to manage PHP, evidence regarding their relative effectiveness on pain reduction and gait improvement is inconclusive. Rigorous evaluation of these programs is needed to establish evidence-based guidelines for physical therapy in this population. Study 1: Comparative Study of Gait and Foot Segment Motion Between Individuals with Plantar Fasciitis and Healthy Controls This study aimed to compare multi-segment foot motion during walking between individuals with plantar fasciitis (PF) and healthy controls. A matched case-control design was used, with gait data collected via a 3D motion capture system and analyzed using the Oxford Foot Model. Study 2: Translation and Validation of the Thai Version of the Foot Function Index (FFI-Th) This study aimed to translate the Foot Function Index (FFI) into Thai (FFI-Th) and evaluate its psychometric properties individuals with plantar foot complaints. Study 3: Effects of Strengthening and Stretching Exercise Programs on Pain and Gait in Patients with Plantar Fasciitis: A Randomized Controlled Trial This study aimed to investigate the effects of physical therapy interventions-specifically strengthening versus stretching exercise programs-on pain and temporospatial gait parameters in patients with PF.

Detailed description

Procedure Study 1: Comparative Study of Gait and Foot Segment Motion Between Individuals with Plantar Fasciitis and Healthy Controls A matched case-control study recruited individuals with PF and matched healthy controls by age, gender, weight, and height. After informed consent, anthropometric data were collected, and participants wore tight clothing to allow accurate marker placement. Forty-two reflective markers were attached to define foot and lower limb segments following the Oxford Foot Model and Plug-In-Gait protocols. A static calibration trial was recorded, after which some markers were removed. Then, participants performed walking trials along an 8-meter walkway while motion capture cameras and force plates recorded kinematic and kinetic data simultaneously. Each participant completed 3-5 gait trials at a self-selected comfortable speed, with two trials matching the control group's gait speed and cadence selected for analysis. Data were filtered and normalized over the gait cycle for further assessment. Outcome measures included ground reaction forces (GRFs) during braking and propulsion phases and peak multi-segment foot joint angles in three planes. Study 2: Translation and Validation of the Thai Version of the Foot Function Index (FFI-Th) This study used a cross-sectional design to translate and validate the Foot Function Index (FFI) into Thai (FFI-Th) following a standardized cross-cultural adaptation process. The steps included independent forward translation by two bilingual translators, synthesis by an expert committee, backward translation by two native English speakers, harmonization through consensus meetings, cognitive interviews with 20 individuals to ensure clarity, and final proofreading by a linguist. To assess criterion validity, participants also completed the EuroQol five-dimensional questionnaire (EQ-5D-5L) for health-related quality of life and a pain visual analogue scale (pain-VAS). These instruments provided comparative data for evaluating the FFI-Th's validity. Study 3; Effects of Strengthening and Stretching Exercise Programs on Pain and Gait in individuals with Plantar Fasciitis: A Randomized Controlled Trial This double-blind, randomized controlled trial was used. Individuals with PF were screened and recruited based on specific inclusion and exclusion criteria. After obtaining informed consent, participants were randomly assigned into two groups: strengthening exercises or stretching exercises. All participants received a standardized physical therapy treatment including therapeutic ultrasound and manual therapy, followed by their assigned exercise programs instructed by blinded physical therapists. Participants performed home-based exercises three times daily for 4 weeks, then continued at home for 2 months with exercise logs to monitor compliance. Outcome assessments were conducted five times: baseline, mid-intervention, post-intervention, and at 1- and 2-month follow-ups. Data collected included demographics, pain intensity via visual analogue scale (VAS), and temporospatial gait parameters measured by a force distribution platform and synchronized video system.

Interventions

Conservative physical therapy treatment with home-based strengthening exercises (study 3)

PROCEDUREStretching exercises

Conservative physical therapy treatment with home-based stretching exercises (study 3)

Sponsors

Thailand Research Fund
CollaboratorOTHER
Mahidol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

Conservative physical therapy intervention was launched by the same physical therapist who blind to participant group allocation.

Intervention model description

A stratified randomization table according to age (less or more than 50 years) and pain score (less or more than 5 out of 10 scores) was used.

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

Study 1: Comparative Study of Gait and Foot Segment Motion Between Individuals with Plantar Fasciitis and Healthy Controls Inclusion Criteria (PF Group): * Aged 20-80 years * Plantar fasciitis (PF) symptoms for at least one month * Pain or tenderness at the medial calcaneal tubercle or proximal plantar fascia * At least one of the following symptoms: * Morning pain (first steps in the morning) * Pain after prolonged sitting * Pain during weight-bearing activities

Exclusion criteria

(PF Group): * Other painful conditions in the lower extremity or back * History of rheumatoid arthritis * Neurological or vascular diseases * Leg length discrepancy \>1 cm * Severe pain preventing walking Inclusion Criteria (Healthy Controls): * No current or previous history of PF symptoms * No foot pain

Design outcomes

Primary

MeasureTime frameDescription
Worst PainBaseline, 2 weeks after the intervention, 4 weeks after the intervention, 1-month follow-up, and 2-month follow-upWorst pain was assessed using the Visual analog scale (VAS), where 0 indicates no pain and 10 indicates pain as bad as participants can imagine. Participants were asked to report their worst pain level over the past 24 hours. Higher scores indicate more severe pain. Unit of Measure: scores
Morning PainBaseline, 2 weeks after the intervention, 4 weeks after the intervention, 1-month follow-up, and 2-month follow-upMorning pain intensity upon waking was assessed using a 10 cm Visual Analog Scale (VAS), where participants mark a point along a continuous line anchored by no pain (0) and worst imaginable pain (10), with higher values indicating more severe morning pain. Unit of Measure: scores

Secondary

MeasureTime frameDescription
CadenceBaseline, 2 weeks after the intervention, 4 weeks after the intervention, 1-month follow-up, and 2-month follow-upCadence refers to the number of steps taken per minute during walking. It is a critical parameter in gait analysis, influencing both performance and injury risk, and the effectiveness of rehabilitation programs. Unit of Measure: steps/minute
Stride LengthBaseline, 2 weeks after the intervention, 4 weeks after the intervention, 1-month follow-up, and 2-month follow-upStride length is the distance covered between two consecutive placements of the same foot during walking. It represents the length of a full gait cycle, encompassing both the stance and swing phases of the same limb. In clinical assessments, stride length is measured to evaluate gait efficiency, balance, and the effectiveness of rehabilitation program. Unit of Measure: meter
Stride TimeBaseline, 2 weeks after the intervention, 4 weeks after the intervention, 1-month follow-up, and 2-month follow-upTime spend during walking over one gait cycle (s) Stride time refers to the duration of one full gait cycle, measured from the initial contact of one foot to the subsequent initial contact of the same foot. It encompasses both the stance and swing phases of the limb's movement. Stride time is a critical temporal parameter in gait analysis, providing insights into the rhythm and coordination of walking. Unit of Measure: second
Gait SpeedBaseline, 2 weeks after the intervention, 4 weeks after the intervention, 1-month follow-up, and 2-month follow-upDistance of walking over time (m/s) Gait speed refers to the rate at which an individual walks. It serves as a crucial indicator of mobility and overall physical fitness, playing a significant role in assessing an individual's balance, endurance, and functional abilities. Unit of Measure: meter/second

Countries

Thailand

Participant flow

Recruitment details

Conducted at Physical Therapy Center, Mahidol University (study 3)

Participants by arm

ArmCount
Strengthening Group
Conservative physical therapy with home-based strengthening exercises
42
Stretching Group
Conservative physical therapy with home-based stretching exercises
42
Total84

Baseline characteristics

CharacteristicStretching GroupTotalStrengthening Group
Age, Continuous52.86 years
STANDARD_DEVIATION 9.84
52.40 years
STANDARD_DEVIATION 9.97
51.95 years
STANDARD_DEVIATION 10.1
Height159.45 cm
STANDARD_DEVIATION 8.13
160.05 cm
STANDARD_DEVIATION 8.67
161.13 cm
STANDARD_DEVIATION 9.18
Pain at worst intensity5.74 scores
STANDARD_DEVIATION 2.3
5.85 scores
STANDARD_DEVIATION 2.3
5.96 scores
STANDARD_DEVIATION 2.3
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
33 Participants62 Participants29 Participants
Sex: Female, Male
Male
9 Participants22 Participants13 Participants
Weight65.14 kg
STANDARD_DEVIATION 12.52
65.40 kg
STANDARD_DEVIATION 11.9
65.66 kg
STANDARD_DEVIATION 11.26

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 420 / 42
other
Total, other adverse events
0 / 420 / 42
serious
Total, serious adverse events
0 / 420 / 42

Outcome results

Primary

Morning Pain

Morning pain intensity upon waking was assessed using a 10 cm Visual Analog Scale (VAS), where participants mark a point along a continuous line anchored by no pain (0) and worst imaginable pain (10), with higher values indicating more severe morning pain. Unit of Measure: scores

Time frame: Baseline, 2 weeks after the intervention, 4 weeks after the intervention, 1-month follow-up, and 2-month follow-up

ArmMeasureGroupValue (MEAN)Dispersion
Strengthening GroupMorning Pain2 weeks after the intervention3.70 scoreStandard Deviation 2.28
Strengthening GroupMorning Pain1-month follow-up2.25 scoreStandard Deviation 2.51
Strengthening GroupMorning Pain4 weeks after the intervention2.90 scoreStandard Deviation 2.46
Strengthening GroupMorning Pain2-month follow-up1.30 scoreStandard Deviation 1.54
Strengthening GroupMorning PainBaseline5.86 scoreStandard Deviation 2.51
Stretching GroupMorning Pain2-month follow-up1.52 scoreStandard Deviation 2.12
Stretching GroupMorning PainBaseline5.04 scoreStandard Deviation 2.35
Stretching GroupMorning Pain2 weeks after the intervention3.63 scoreStandard Deviation 2.54
Stretching GroupMorning Pain4 weeks after the intervention2.75 scoreStandard Deviation 2.52
Stretching GroupMorning Pain1-month follow-up1.98 scoreStandard Deviation 2.24
Comparison: Baselinep-value: 0.128t-test, 2 sided
Comparison: 2 weeks after the interventionp-value: 0.889t-test, 2 sided
Comparison: 4 weeks after the interventionp-value: 0.793t-test, 2 sided
Comparison: 1-month follow-upp-value: 0.602t-test, 2 sided
Comparison: 2-month follow-upp-value: 0.574t-test, 2 sided
Comparison: Within group comparisonp-value: <0.001ANOVA
Comparison: Within group comparisonp-value: <0.001ANOVA
Primary

Worst Pain

Worst pain was assessed using the Visual analog scale (VAS), where 0 indicates no pain and 10 indicates pain as bad as participants can imagine. Participants were asked to report their worst pain level over the past 24 hours. Higher scores indicate more severe pain. Unit of Measure: scores

Time frame: Baseline, 2 weeks after the intervention, 4 weeks after the intervention, 1-month follow-up, and 2-month follow-up

ArmMeasureGroupValue (MEAN)Dispersion
Strengthening GroupWorst Pain2 weeks after the intervention3.91 scoreStandard Deviation 2.38
Strengthening GroupWorst Pain1-month follow-up2.52 scoreStandard Deviation 2.55
Strengthening GroupWorst Pain4 weeks after the intervention3.09 scoreStandard Deviation 2.25
Strengthening GroupWorst Pain2-month follow-up1.73 scoreStandard Deviation 2.16
Strengthening GroupWorst PainBaseline5.96 scoreStandard Deviation 2.3
Stretching GroupWorst Pain2-month follow-up2.69 scoreStandard Deviation 2.55
Stretching GroupWorst PainBaseline5.74 scoreStandard Deviation 2.3
Stretching GroupWorst Pain2 weeks after the intervention4.08 scoreStandard Deviation 2.29
Stretching GroupWorst Pain4 weeks after the intervention3.34 scoreStandard Deviation 2.47
Stretching GroupWorst Pain1-month follow-up2.69 scoreStandard Deviation 2.55
Comparison: Baselinep-value: 0.66t-test, 2 sided
Comparison: 2 weeks after the interventionp-value: 0.734t-test, 2 sided
Comparison: 4 weeks after the interventionp-value: 0.629t-test, 2 sided
Comparison: 1-month follow-upp-value: 0.752t-test, 2 sided
Comparison: 2-month follow-upp-value: 0.512t-test, 2 sided
Comparison: Within group comparisonp-value: <0.001ANOVA
Comparison: Within group comparisonp-value: <0.001ANOVA
Secondary

Cadence

Cadence refers to the number of steps taken per minute during walking. It is a critical parameter in gait analysis, influencing both performance and injury risk, and the effectiveness of rehabilitation programs. Unit of Measure: steps/minute

Time frame: Baseline, 2 weeks after the intervention, 4 weeks after the intervention, 1-month follow-up, and 2-month follow-up

ArmMeasureGroupValue (MEAN)Dispersion
Strengthening GroupCadenceBaseline103.16 steps/minuteStandard Deviation 7.75
Strengthening GroupCadence4 weeks after the intervention104.03 steps/minuteStandard Deviation 8.42
Strengthening GroupCadence2-month follow-up105.50 steps/minuteStandard Deviation 8.47
Strengthening GroupCadence1-month follow-up104.72 steps/minuteStandard Deviation 8.45
Strengthening GroupCadence2 weeks after the intervention102.85 steps/minuteStandard Deviation 8.54
Stretching GroupCadence2-month follow-up104.81 steps/minuteStandard Deviation 9.49
Stretching GroupCadenceBaseline101.37 steps/minuteStandard Deviation 10.44
Stretching GroupCadence2 weeks after the intervention103.70 steps/minuteStandard Deviation 9.82
Stretching GroupCadence4 weeks after the intervention103.46 steps/minuteStandard Deviation 10.42
Stretching GroupCadence1-month follow-up104.16 steps/minuteStandard Deviation 9.35
Comparison: 4 weeks after the interventionp-value: 0.781t-test, 2 sided
Comparison: 2 weeks after the interventionp-value: 0.674t-test, 2 sided
Comparison: Baselinep-value: 0.374t-test, 2 sided
Comparison: 1-month follow-upp-value: 0.778t-test, 2 sided
Comparison: 2-month follow-upp-value: 0.727t-test, 2 sided
Comparison: Within group comparisonp-value: 0.014ANOVA
Comparison: Within group comparisonp-value: 0.002ANOVA
Secondary

Gait Speed

Distance of walking over time (m/s) Gait speed refers to the rate at which an individual walks. It serves as a crucial indicator of mobility and overall physical fitness, playing a significant role in assessing an individual's balance, endurance, and functional abilities. Unit of Measure: meter/second

Time frame: Baseline, 2 weeks after the intervention, 4 weeks after the intervention, 1-month follow-up, and 2-month follow-up

ArmMeasureGroupValue (MEAN)Dispersion
Strengthening GroupGait Speed2-month follow-up0.94 meter/secondStandard Deviation 0.12
Strengthening GroupGait SpeedBaseline0.90 meter/secondStandard Deviation 0.11
Strengthening GroupGait Speed2 weeks after the intervention0.91 meter/secondStandard Deviation 0.12
Strengthening GroupGait Speed4 weeks after the intervention0.92 meter/secondStandard Deviation 0.12
Strengthening GroupGait Speed1-month follow-up0.93 meter/secondStandard Deviation 0.12
Stretching GroupGait Speed1-month follow-up0.93 meter/secondStandard Deviation 0.13
Stretching GroupGait Speed4 weeks after the intervention0.91 meter/secondStandard Deviation 0.13
Stretching GroupGait SpeedBaseline0.87 meter/secondStandard Deviation 0.13
Stretching GroupGait Speed2-month follow-up0.94 meter/secondStandard Deviation 0.13
Stretching GroupGait Speed2 weeks after the intervention0.91 meter/secondStandard Deviation 0.13
Comparison: Baselinep-value: 0.287t-test, 2 sided
Comparison: 2 weeks after the interventionp-value: 0.861t-test, 2 sided
Comparison: 4 weeks after the interventionp-value: 0.641t-test, 2 sided
Comparison: 1-month follow-upp-value: 0.864t-test, 2 sided
Comparison: 2-month follow-upp-value: 0.888t-test, 2 sided
Comparison: Within group comparisonp-value: 0.262ANOVA
Comparison: Within group comparisonp-value: <0.001ANOVA
Secondary

Stride Length

Stride length is the distance covered between two consecutive placements of the same foot during walking. It represents the length of a full gait cycle, encompassing both the stance and swing phases of the same limb. In clinical assessments, stride length is measured to evaluate gait efficiency, balance, and the effectiveness of rehabilitation program. Unit of Measure: meter

Time frame: Baseline, 2 weeks after the intervention, 4 weeks after the intervention, 1-month follow-up, and 2-month follow-up

ArmMeasureGroupValue (MEAN)Dispersion
Strengthening GroupStride LengthBaseline1.05 meterStandard Deviation 0.11
Strengthening GroupStride Length1-month follow-up1.07 meterStandard Deviation 0.09
Strengthening GroupStride Length4 weeks after the intervention1.05 meterStandard Deviation 0.1
Strengthening GroupStride Length2-month follow-up1.07 meterStandard Deviation 0.1
Strengthening GroupStride Length2 weeks after the intervention1.06 meterStandard Deviation 0.1
Stretching GroupStride Length2-month follow-up1.08 meterStandard Deviation 0.1
Stretching GroupStride Length2 weeks after the intervention1.06 meterStandard Deviation 0.1
Stretching GroupStride Length4 weeks after the intervention1.05 meterStandard Deviation 0.1
Stretching GroupStride Length1-month follow-up1.07 meterStandard Deviation 0.11
Stretching GroupStride LengthBaseline1.03 meterStandard Deviation 0.1
Comparison: Baselinep-value: 0.39t-test, 2 sided
Comparison: 2 weeks after the interventionp-value: 0.77t-test, 2 sided
Comparison: 4 weeks after the interventionp-value: 0.603t-test, 2 sided
Comparison: 1-month follow-upp-value: 0.922t-test, 2 sided
Comparison: 2-month follow-upp-value: 0.56t-test, 2 sided
Comparison: Within group comparisonp-value: 0.181ANOVA
Comparison: Within group comparisonp-value: <0.001ANOVA
Secondary

Stride Time

Time spend during walking over one gait cycle (s) Stride time refers to the duration of one full gait cycle, measured from the initial contact of one foot to the subsequent initial contact of the same foot. It encompasses both the stance and swing phases of the limb's movement. Stride time is a critical temporal parameter in gait analysis, providing insights into the rhythm and coordination of walking. Unit of Measure: second

Time frame: Baseline, 2 weeks after the intervention, 4 weeks after the intervention, 1-month follow-up, and 2-month follow-up

ArmMeasureGroupValue (MEAN)Dispersion
Strengthening GroupStride Time4 weeks after the intervention1.15 secondStandard Deviation 0.1
Strengthening GroupStride Time1-month follow-up1.15 secondStandard Deviation 0.1
Strengthening GroupStride Time2-month follow-up1.14 secondStandard Deviation 0.1
Strengthening GroupStride TimeBaseline1.17 secondStandard Deviation 0.09
Strengthening GroupStride Time2 weeks after the intervention1.17 secondStandard Deviation 0.1
Stretching GroupStride Time2 weeks after the intervention1.16 secondStandard Deviation 0.12
Stretching GroupStride Time4 weeks after the intervention1.17 secondStandard Deviation 0.13
Stretching GroupStride TimeBaseline1.19 secondStandard Deviation 0.13
Stretching GroupStride Time1-month follow-up1.16 secondStandard Deviation 0.11
Stretching GroupStride Time2-month follow-up1.15 secondStandard Deviation 0.11
Comparison: Baselinep-value: 0.334t-test, 2 sided
Comparison: 2 weeks after the interventionp-value: 0.766t-test, 2 sided
Comparison: 4 weeks after the interventionp-value: 0.598t-test, 2 sided
Comparison: 1-month follow-upp-value: 0.682t-test, 2 sided
Comparison: 2-month follow-upp-value: 0.707t-test, 2 sided
Comparison: Within group comparisonp-value: 0.008ANOVA
Comparison: Within group comparisonp-value: 0.002ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026