Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Thailand Research Fund | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Strengthening group | Experimental | Individuals with PF who received strengthening exercises. (study 3) |
|
| Stretching group | Active Comparator | Individuals with PF who received stretching exercises. (study 3) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Strengthening exercises | Procedure | Conservative physical therapy treatment with home-based strengthening exercises (study 3) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, 2 weeks after the intervention, 4 weeks after the intervention, 1-month follow-up, and 2-month follow-up |
| 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 | Baseline, 2 weeks after the intervention, 4 weeks after the intervention, 1-month follow-up, and 2-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, 2 weeks after the intervention, 4 weeks after the intervention, 1-month follow-up, and 2-month follow-up |
Not provided
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:
Exclusion Criteria (PF Group):
Inclusion Criteria (Healthy Controls):
Exclusion Criteria (Healthy Controls):
• Same as those listed for the PF group
Study 2: Translation and Validation of the Thai Version of the Foot Function Index (FFI-Th) Inclusion Criteria (Individuals with plantar problems)
Study 3: Effects of Strengthening and Stretching Exercise Programs on Pain and Gait in Patients with Plantar Fasciitis: A Randomized Controlled Trial Inclusion Criteria:
Exclusion Criteria:
History of back or lower limb surgery within 6 months
Recent trauma or corticosteroid injections (within 6 months)
Leg length discrepancy greater than 1 cm
Pregnancy
Inability to perform the exercise program
Receiving other ongoing treatments or performing other foot-specific exercises
Coexisting conditions including:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sunee Bovonsunthonchai, PhD | Mahidol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Motion analysis laboratory | Salaya | Nakhonpathom | Thailand | |||
| Physical therapy center, Physical therapy faculty, Mahidol University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25361863 | Background | Martin RL, Davenport TE, Reischl SF, McPoil TG, Matheson JW, Wukich DK, McDonough CM; American Physical Therapy Association. Heel pain-plantar fasciitis: revision 2014. J Orthop Sports Phys Ther. 2014 Nov;44(11):A1-33. doi: 10.2519/jospt.2014.0303. | |
| 16342847 | Background | Cole C, Seto C, Gazewood J. Plantar fasciitis: evidence-based review of diagnosis and therapy. Am Fam Physician. 2005 Dec 1;72(11):2237-42. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Conducted at Physical Therapy Center, Mahidol University (study 3)
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Strengthening Group | Conservative physical therapy with home-based strengthening exercises (study 3) |
| FG001 | Stretching Group | conservative physical therapy with home-based stretching exercises (study 3) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
| |||||||||||||
| 2 Weeks After the Intervention |
| |||||||||||||
| 4 Weeks After the Intervention |
| |||||||||||||
| 1-month Follow-up |
| |||||||||||||
| 2-month Follow-up |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Strengthening Group | Conservative physical therapy with home-based strengthening exercises |
| BG001 | Stretching Group | Conservative physical therapy with home-based stretching exercises |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | score | Baseline, 2 weeks after the intervention, 4 weeks after the intervention, 1-month follow-up, and 2-month follow-up |
|
3 months in total per participants. Adverse events were monitored over a total of 3 months, which includes a 4-week (1-month) intervention phase plus a subsequent 2-month follow-up phase.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Strengthening Group | Conservative physical therapy with home-based strengthening exercises |
Not provided
Not provided
This study did not compare to the pure conservative physical therapy treatment, which may provide more information about the effectiveness of strengthening and stretching exercises that may superior to the conservative treatment alone.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Asst.Prof.Dr. Sunee Bovonsunthonchai | Physical Therapy Faculty, Mahidol University | 024415450 | 20804 | sunee.bov@mahidol.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 30, 2016 | Jun 13, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D036981 | Fasciitis, Plantar |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D005208 | Fasciitis |
| D009140 | Musculoskeletal Diseases |
| D005534 | Foot Diseases |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D052580 | Muscle Stretching Exercises |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
Not provided
Not provided
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.
Not provided
Not provided
Conservative physical therapy intervention was launched by the same physical therapist who blind to participant group allocation.
| Stretching exercises | Procedure | Conservative physical therapy treatment with home-based stretching exercises (study 3) |
|
| 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 | Baseline, 2 weeks after the intervention, 4 weeks after the intervention, 1-month follow-up, and 2-month follow-up |
| 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 | Baseline, 2 weeks after the intervention, 4 weeks after the intervention, 1-month follow-up, and 2-month follow-up |
| 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 | Baseline, 2 weeks after the intervention, 4 weeks after the intervention, 1-month follow-up, and 2-month follow-up |
| Bangkok |
| 10700 |
| Thailand |
| 12756315 | Background | Lemont H, Ammirati KM, Usen N. Plantar fasciitis: a degenerative process (fasciosis) without inflammation. J Am Podiatr Med Assoc. 2003 May-Jun;93(3):234-7. doi: 10.7547/87507315-93-3-234. |
| 24992816 | Background | Chang R, Rodrigues PA, Van Emmerik RE, Hamill J. Multi-segment foot kinematics and ground reaction forces during gait of individuals with plantar fasciitis. J Biomech. 2014 Aug 22;47(11):2571-7. doi: 10.1016/j.jbiomech.2014.06.003. Epub 2014 Jun 11. |
| 15595298 | Background | Wearing SC, Smeathers JE, Yates B, Sullivan PM, Urry SR, Dubois P. Sagittal movement of the medial longitudinal arch is unchanged in plantar fasciitis. Med Sci Sports Exerc. 2004 Oct;36(10):1761-7. doi: 10.1249/01.mss.0000142297.10881.11. |
| 23369667 | Background | Budiman-Mak E, Conrad KJ, Mazza J, Stuck RM. A review of the foot function index and the foot function index - revised. J Foot Ankle Res. 2013 Feb 1;6(1):5. doi: 10.1186/1757-1146-6-5. |
| 18822153 | Result | Hill CL, Gill TK, Menz HB, Taylor AW. Prevalence and correlates of foot pain in a population-based study: the North West Adelaide health study. J Foot Ankle Res. 2008 Jul 28;1(1):2. doi: 10.1186/1757-1146-1-2. |
| 25237175 | Result | Sullivan J, Burns J, Adams R, Pappas E, Crosbie J. Musculoskeletal and activity-related factors associated with plantar heel pain. Foot Ankle Int. 2015 Jan;36(1):37-45. doi: 10.1177/1071100714551021. Epub 2014 Sep 18. |
| 21387326 | Result | Rathleff MS, Moelgaard C, Lykkegaard Olesen J. Intra- and interobserver reliability of quantitative ultrasound measurement of the plantar fascia. J Clin Ultrasound. 2011 Mar-Apr;39(3):128-34. doi: 10.1002/jcu.20787. Epub 2011 Jan 10. |
| 16882901 | Result | Digiovanni BF, Nawoczenski DA, Malay DP, Graci PA, Williams TT, Wilding GE, Baumhauer JF. Plantar fascia-specific stretching exercise improves outcomes in patients with chronic plantar fasciitis. A prospective clinical trial with two-year follow-up. J Bone Joint Surg Am. 2006 Aug;88(8):1775-81. doi: 10.2106/JBJS.E.01281. |
| 25145882 | Result | Rathleff MS, Molgaard CM, Fredberg U, Kaalund S, Andersen KB, Jensen TT, Aaskov S, Olesen JL. High-load strength training improves outcome in patients with plantar fasciitis: A randomized controlled trial with 12-month follow-up. Scand J Med Sci Sports. 2015 Jun;25(3):e292-300. doi: 10.1111/sms.12313. Epub 2014 Aug 21. |
| 32944253 | Derived | Bovonsunthonchai S, Thong-On S, Vachalathiti R, Intiravoranont W, Suwannarat S, Smith R. Thai version of the foot function index: a cross-cultural adaptation with reliability and validity evaluation. BMC Sports Sci Med Rehabil. 2020 Sep 10;12:56. doi: 10.1186/s13102-020-00206-8. eCollection 2020. |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Height | Mean | Standard Deviation | cm |
|
| Pain at worst intensity | Pain at worst intensity 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 | Mean | Standard Deviation | scores |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | score | Baseline, 2 weeks after the intervention, 4 weeks after the intervention, 1-month follow-up, and 2-month follow-up |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | steps/minute | Baseline, 2 weeks after the intervention, 4 weeks after the intervention, 1-month follow-up, and 2-month follow-up |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | meter | Baseline, 2 weeks after the intervention, 4 weeks after the intervention, 1-month follow-up, and 2-month follow-up |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | second | Baseline, 2 weeks after the intervention, 4 weeks after the intervention, 1-month follow-up, and 2-month follow-up |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | meter/second | Baseline, 2 weeks after the intervention, 4 weeks after the intervention, 1-month follow-up, and 2-month follow-up |
|
|
|
|
| 0 |
| 42 |
| 0 |
| 42 |
| 0 |
| 42 |
| EG001 | Stretching Group | Conservative physical therapy with home-based stretching exercises | 0 | 42 | 0 | 42 | 0 | 42 |
Not provided
Not provided
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| 4 weeks after the intervention |
|
| 1-month follow-up |
|
| 2-month follow-up |
|
| 0.889 |
| Superiority |
| 4 weeks after the intervention | t-test, 2 sided | 0.793 | Superiority |
| 1-month follow-up | t-test, 2 sided | 0.602 | Superiority |
| 2-month follow-up | t-test, 2 sided | 0.574 | Superiority |
| Within group comparison | ANOVA | <0.001 | Superiority |
| Within group comparison | ANOVA | <0.001 | Superiority |
| 4 weeks after the intervention |
|
| 1-month follow-up |
|
| 2-month follow-up |
|
| 0.674 |
| Superiority |
| 4 weeks after the intervention | t-test, 2 sided | 0.781 | Superiority |
| 1-month follow-up | t-test, 2 sided | 0.778 | Superiority |
| 2-month follow-up | t-test, 2 sided | 0.727 | Superiority |
| Within group comparison | ANOVA | 0.014 | Superiority |
| Within group comparison | ANOVA | 0.002 | Superiority |
| 4 weeks after the intervention |
|
| 1-month follow-up |
|
| 2-month follow-up |
|
| 0.770 |
| Superiority |
| 4 weeks after the intervention | t-test, 2 sided | 0.603 | Superiority |
| 1-month follow-up | t-test, 2 sided | 0.922 | Superiority |
| 2-month follow-up | t-test, 2 sided | 0.560 | Superiority |
| Within group comparison | ANOVA | 0.181 | Superiority |
| Within group comparison | ANOVA | <0.001 | Superiority |
| 4 weeks after the intervention |
|
| 1-month follow-up |
|
| 2-month follow-up |
|
| 0.766 |
| Superiority |
| 4 weeks after the intervention | t-test, 2 sided | 0.598 | Superiority |
| 1-month follow-up | t-test, 2 sided | 0.682 | Superiority |
| 2-month follow-up | t-test, 2 sided | 0.707 | Superiority |
| Within group comparison | ANOVA | 0.008 | Superiority |
| Within group comparison | ANOVA | 0.002 | Superiority |
| 4 weeks after the intervention |
|
| 1-month follow-up |
|
| 2-month follow-up |
|
| 0.861 |
| Superiority |
| 4 weeks after the intervention | t-test, 2 sided | 0.641 | Superiority |
| 1-month follow-up | t-test, 2 sided | 0.864 | Superiority |
| 2-month follow-up | t-test, 2 sided | 0.888 | Superiority |
| Within group comparison | ANOVA | 0.262 | Superiority |
| Within group comparison | ANOVA | <0.001 | Superiority |