NCT06567509

Brief Summary

Flexible flat foot is a very common musculoskeletal disorder of lower limbs in general population. Studies have reported that a flexible flat foot causes an alteration in the human body structures and lower limb kinetics due to a rotational torque in the tibia and femur which in turn affects the lumbar spine. This altered mechanics affects the musculature around the lumbar spine especially the core muscles. A strong link between core muscles and lower limb control, foot posture and pressure force has been found in previous studies. While the role of core muscles on lower limb posture and functions has been determined, there is lack of evidence on the benefits of core stabilization exercises on foot arch deficits. Hence, the proposed study will determine the exercise components of core muscles training that are relevant for the flat foot pathology and then will experiment its effects on the foot posture and function. The first step of the proposed study will begin with an extensive literature survey to identify the components of core stability training that have been recommended in the management of lower limbs dysfunction. Then, a protocol of core muscles training will be devised and followed up with a pilot study where the purpose will be to assess the feasibility of the training protocol. The final step of the proposed study will be an experimental study. The subjects for the experimental study will be selected based on predetermined inclusion and exclusion criteria and will be allocated alternately into experimental and control group. The experimental group will receive core stability training as an intervention. Whereas the control group will receive traditional conventional physiotherapy treatment. The foot posture, foot function and lower limb alignment will be assessed before and after the completion of treatment protocol. The data will be analyzed for any differences between group differences and between group differences. The outcomes of the proposed study may have an implication in the lower limb alignment and foot arch correction strategies.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

October 16, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2026

Completed
3 months until next milestone

Results Posted

Study results publicly available

April 14, 2026

Completed
Last Updated

April 14, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

August 19, 2024

Results QC Date

January 20, 2026

Last Update Submit

March 25, 2026

Conditions

Keywords

Flexible FlatfootCore stabilityMuscle endurance

Outcome Measures

Primary Outcomes (4)

  • Staheli Plantar Arch Index (SPAI)

    A 5 mm rubber pad was inked and used to ink the participant's foot. Participants sat first, then placed the testing foot on the inked pad and stood in tandem stance with the non-testing foot outside. A half-squat with slight hip and knee flexion ensured full foot contact. The inked foot was then placed on A4 paper while repeating the half-squat to transfer a clear footprint. A line of tangency from most medial foot edge and the heel was drawn using a ruler. Perpendicular line was drawn from midpoint of this line, crossing foot. Same procedure was repeated for heel tangency point. This process provided the measurements of the support width of the midfoot region (A) and the heel region (B) in millimeters. The Plantar Arch Index (PI) was then calculated using the formula (Plantar Arch Index (PI)=A/B) in millimeters. 0.8 mm = flexible flatfoot ↓ Arch Index = improvement (Putu Janiartha et al., 2023) Values represent mean change scores (post-pre), comparisons performed using MANCOVA

    Measured at baseline and after 6 weeks of Intervention

  • Foot Posture (Rare Foot Angle)

    The rear foot angle (RFA) will be used to assess the calcaneal valgus. Four points will be marker in the lower limb with the subject is in standing position with talus in neutral position: Base of calcaneus as mark 1, Subtalar joint (Centre of Achillies tendon attachment) as mark 2 and centre of posterior aspect of calf 15 cm above the 2nd mark as mark 3. A straight line will be drawn using a marker from point 2 to point 1. Then a line will be drawn from point 3 to point 2. The angle formed between the two lines with point 2 as fulcrum is the rare foot angle and will be measure using a universal goniometer. The values represent mean change scores (post-pre). Group comparisons were performed using MANCOVA.

    Will be assessed at baseline and after 6 weeks in both the groups.

  • Lower Limb Alignment (Left Q Angle)

    The 'Q angle' will be measured by extending a line from anterior superior iliac spine of the pelvic bone to the center point of patella and extending another line from tibial tubercle of tibia to the center point of patella. The junction between these two lines is the 'Q angle' and will be measured using a universal goniometer. Values represent mean change scores (post-pre).

    Will be assessed at baseline and after 6 weeks in both the groups.

  • Foot Function Index (FFI)

    The Foot Function Index (FFI) was initially included as an outcome measure in the study protocol. However, during the implementation phase, it was found to have feasibility limitations and reduced sensitivity in detecting changes within the study population. Therefore, the FFI was not collected for the main trial, and no data are reported for this outcome.

    Planned to assess at baseline and after 6 weeks of intervention

Secondary Outcomes (3)

  • Core Muscle Endurance (MacGill Protocol): Isometric Extensor Test

    Will be assessed at baseline and after 6 weeks in both the groups.

  • Core Muscle Endurance (MacGill Protocol): Isometric Flexor Test

    Will be assessed at baseline and after 6 weeks in both the groups.

  • Core Muscle Endurance (MacGill Protocol): Isometric Flexor Test (Side Bridges Test, Left & Right)

    Will be assessed at baseline and after 6 weeks in both the groups.

Study Arms (4)

Pilot experimental group

EXPERIMENTAL

Phase 1: 1. Cross Curl 10 rept × 3 times 120 sec rest between the sets 2. Bridges with leg lift 15 sec hold × 3 times 120 sec rest between the sets Side bridges (left and right) 15 sec hold × 3 times 120 sec rest between the sets 3. Planks on feet 15 sec hold × 3 times 120 sec rest between the sets 4. Quadripedal stance. 15 sec hold × 3 times 120 sec rest between the sets Phase 2: 1. Cross Curl ups 15 rept × 3 times 120 sec rest between the sets 2. Bridges with leg lift 20 sec hold × 3 times 120 sec rest between the sets Side bridges (left and right) 20 sec hold × 3 times 120 sec rest between the sets 3. Planks on feet 20 sec hold × 3 times 120 sec rest between the sets 4. Quadripedal stance 20 sec hold × 3 times 120 sec rest between the sets Phase 3: 1. Cross Curl ups 25 rept × 3 times 120 sec rest between the sets 2. Bridges with leg lift / side bridge/Planks/Quadreped 25 sec hold × 3 times 120 sec rest between the sets.

Other: Core stability exercises and Short foot exercises

Pilot Control group

OTHER

Conventional foot exercises for control group (3 times weekly for 6 weeks) A. Warm up: Active ROM exercise (Knee and hip flexion) 10 repetitions × 2 sets) B. Training: * Active dorsiflexion exercises in long sitting (10 sec hold × 15 repetitions ×2 sets) * Active plantarflexion exercises in long sitting (10 sec hold × 15 repetitions ×2 sets) * Active inversion exercises in long sitting (10 sec hold × 15 repetitions ×2 sets) * Active eversion exercises in long sitting (10 sec hold × 15 repetitions ×2 sets) C. Cool down: • Calf stretches in long sitting for 10 sec hold × 3 sets.

Other: Conventional foot exercises and short foot exercises

Main RCT Experimental group

EXPERIMENTAL

Phase 1: 1. Cross Curl 10 rept × 3 times 120 sec rest between the sets 2. Bridges with leg lift 15 sec hold × 3 times 120 sec rest between the sets Side bridges (left and right) 15 sec hold × 3 times 120 sec rest between the sets 3. Planks on feet 15 sec hold × 3 times 120 sec rest between the sets 4. Quadripedal stance. 20 sec hold × 3 times 120 sec rest between the sets Phase 2: 1. Cross Curl ups 15 rept × 3 times 120 sec rest between the sets 2. Bridges with leg lift 20 sec hold × 3 times 120 sec rest between the sets Side bridges (left and right) 20 sec hold × 3 times 120 sec rest between the sets 3. Planks on feet 20 sec hold × 3 times 120 sec rest between the sets 4. Quadripedal stance 20 sec hold × 3 times 120 sec rest between the sets Phase 3 : 1. Cross Curl ups 20 rept × 3 times 120 sec rest between the sets 2. Bridges with leg lift / side bridges/ planks/Quadrepedal stance 20 sec hold each × 3 times 120 sec rest between the sets

Other: Core stability exercises and Short foot exercises

Main RCT Control Group

OTHER

Conventional foot exercises for control group (3 times weekly for 6 weeks) A. Warm up: Active ROM exercise (Knee and hip flexion) 10 repetitions × 2 sets) B. Training: * Active dorsiflexion exercises in long sitting (10 sec hold × 15 repetitions ×2 sets) * Active plantarflexion exercises in long sitting (10 sec hold × 15 repetitions ×2 sets) * Active inversion exercises in long sitting (10 sec hold × 15 repetitions ×2 sets) * Active eversion exercises in long sitting (10 sec hold × 15 repetitions ×2 sets) C. Cool down: • Calf stretches in long sitting for 10 sec hold × 3 sets.

Other: Conventional foot exercises and short foot exercises

Interventions

Core stabilty exercises are the exercises where subjects will be trained to perform exercises like: Curl ups, bridging, side bridges, Planks, and Quadripedal stance exercises in a phased manner, each phase lasting 2 weeks. Complexities and duration of exercises will be increased in each phase. Short foot exercises for control group will include traditional treatment of stretching and strengthening of foot musculature.

Main RCT Experimental groupPilot experimental group

Ankle dorsiflexion, Plantar flexion, Inversion and Eversion range of motion exercises

Main RCT Control GroupPilot Control group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects of age group 18 to 30 years.
  • Both males and females.
  • No recent history of lower limb injuries.
  • Subjects with bilateral flexible flat feet as per the definition.
  • Subjects with positive navicular drop test (\> 10mm).
  • Subjects with Positive Jack toe rising test.

You may not qualify if:

  • Rigid flat foot
  • Subject who are involved in a specific sport at least 2 h /day and 3 times a week regularly.
  • History of arthritic symptoms of lower limb joints.
  • History of any ligament or tendon injuries around ankle, knee, or hip joint.
  • History of any limb surgery or back surgery.
  • Chronic back pain.
  • Any history of neurological deficit or diabetic neuropathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Rehabilitation Sciences / Kulliyah of Allied Health Sciences / International Islamic university of Malaysia

Kuantan, Pahang, 25200, Malaysia

Location

Related Publications (7)

  • Juniartha, I. P., Tinduh, D., Nugraheni, N., Pawana, I. P. A., Setiawati, R., & Melaniani, S. (2023). The validity and reliability of various footprint analysis in flatfoot diagnosis of competitive athletes. Bali Medical Journal, 12(1), 851-856. https://doi.org/10.15562/bmj.v12i1.4071

    BACKGROUND
  • Aenumulapalli A, Kulkarni MM, Gandotra AR. Prevalence of Flexible Flat Foot in Adults: A Cross-sectional Study. J Clin Diagn Res. 2017 Jun;11(6):AC17-AC20. doi: 10.7860/JCDR/2017/26566.10059. Epub 2017 Jun 1.

    PMID: 28764143BACKGROUND
  • Anvita Telang, & Supriya Dhumale. (2020). Comparison of Core Stability in Individuals with Flexible Flat Foot and Normal Foot. International Journal of Science and Research. 9 (5), 1232-1243.

    BACKGROUND
  • Brijwasi T, Borkar P. A comprehensive exercise program improves foot alignment in people with flexible flat foot: a randomised trial. J Physiother. 2023 Jan;69(1):42-46. doi: 10.1016/j.jphys.2022.11.011. Epub 2022 Dec 14.

    PMID: 36526555BACKGROUND
  • Eloho Nyerhovwo Igbinedion, Augustina Oghenevwaerhe Jewo, God'swill Okoro, & John Chinedu Obianke. (2022). Prevalence of Flat Foot using Plantar Arch Index among Young Adults of Delta State Nigeria. Mal J Med Health Sci,18(3), 112-117.

    BACKGROUND
  • Khamis S, Yizhar Z. Effect of feet hyperpronation on pelvic alignment in a standing position. Gait Posture. 2007 Jan;25(1):127-34. doi: 10.1016/j.gaitpost.2006.02.005. Epub 2006 Apr 18.

    PMID: 16621569BACKGROUND
  • Chevidikunnan MF, Al Saif A, Gaowgzeh RA, Mamdouh KA. Effectiveness of core muscle strengthening for improving pain and dynamic balance among female patients with patellofemoral pain syndrome. J Phys Ther Sci. 2016 May;28(5):1518-23. doi: 10.1589/jpts.28.1518. Epub 2016 May 31.

    PMID: 27313363BACKGROUND

MeSH Terms

Conditions

Flatfoot

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Limitations and Caveats

The study included a small sample of young adults. Therefore, findings may have limited generalizability beyond the studied population.

Results Point of Contact

Title
Shahid Mohd Dar
Organization
International Islamic University of Malaysia

Study Officials

  • Shahid M Dar, MPT

    International Islamic University of Malaysia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
In both the phases ,both groups will have different careproviders and therapists treating, so blinding is not required. But the Assessors who assessed outcome measurements before and after treatment were blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study will have two phases First phase(Pilot RCT study) Second phase (Randomized control trial). But The pilot study was only to report feasibility and acceptability of intervention programme.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

August 19, 2024

First Posted

August 22, 2024

Study Start

October 16, 2024

Primary Completion

January 15, 2026

Study Completion

January 16, 2026

Last Updated

April 14, 2026

Results First Posted

April 14, 2026

Record last verified: 2026-03

Locations