NCT07229079

Brief Summary

This study investigates whether adding Basic Body Awareness Therapy (BBAT) to Short Foot Exercises (SFE) improves pes planus, balance, and body awareness in adults with flexible pes planus. Fifty participants aged 18-45 will be randomly assigned to either a BBAT + SFE group or an SFE-only control group. The interventions will last eight weeks with supervised sessions twice weekly and additional home exercises. Outcomes will be measured before, after, and two months post-intervention.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

January 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2025

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

10 months

First QC Date

November 13, 2025

Last Update Submit

November 14, 2025

Conditions

Keywords

Short Foot Exercises (SFE)Basic Body Awareness Therapy (BBAT)Pes PlanusBalanceProprioceptionFlatfoot

Outcome Measures

Primary Outcomes (4)

  • Navicular Drop Test

    Assessment of medial longitudinal arch height to determine presence and severity of pes planus. Test performed in both sitting (non-weight-bearing) and standing (weight-bearing) positions. Difference ≥10 mm indicates pes planus.

    Baseline (pre-intervention), post-intervention (8 weeks), follow-up (2 months after intervention)

  • Dynamic Balance

    Y Balance Test measuring reach distance in anterior, posteromedial, and posterolateral directions. Results normalized to leg length.

    Baseline, post-intervention (8 weeks), follow-up (2 months)

  • Proprioception

    Active and passive joint position sense of the ankle measured with digital goniometer. Eyes closed; angular error from target angle recorded.

    Baseline, post-intervention (8 weeks), follow-up (2 months)

  • Light Touch Sensation

    Semmes-Weinstein Monofilament Test at seven foot reference points. Threshold of sensation recorded.

    Baseline, post-intervention (8 weeks), follow-up (2 months)

Secondary Outcomes (7)

  • Foot Function Index - Pain Subscale

    Baseline, post-intervention (8 weeks), follow-up (2 months)

  • Foot Function Index - Disability Subscale

    Baseline, post-intervention (8 weeks), follow-up (2 months)

  • Foot Function Index - Activity Limitation Subscale

    Baseline, post-intervention (8 weeks), follow-up (2 months)

  • Foot Function Index - Total Score

    Baseline, post-intervention (8 weeks), follow-up (2 months)

  • Static Balance

    Baseline, post-intervention (8 weeks), follow-up (2 months)

  • +2 more secondary outcomes

Study Arms (2)

BBAT Group

EXPERIMENTAL

Participants will receive Short Foot Exercises (SFE) plus Basic Body Awareness Therapy (BBAT).

Behavioral: Basic Body Awareness Therapy (BBAT)Behavioral: Short Foot Exercises (SFE)

Control Group

ACTIVE COMPARATOR

Participants will receive only Short Foot Exercises (SFE).

Behavioral: Short Foot Exercises (SFE)

Interventions

Participants will perform Basic Body Awareness Therapy (BBAT) combined with SFE for 8 weeks. BBAT sessions are 45 minutes, twice weekly in small groups under a certified physiotherapist. Exercises target postural control, motor coordination, body awareness, balance, and functional movement, progressing from supine to sitting, standing, and walking positions. After each BBAT session, participants perform SFE following the same progression as the Control Group.

BBAT Group

Participants will perform Short Foot Exercises (SFE) for 8 weeks. Sessions are twice weekly under physiotherapist supervision in small groups (3-8 participants) and 5 days/week at home. Exercises progress from sitting (weeks 1-2), standing (weeks 3-4), single-leg (weeks 5-6), to functional activities (weeks 7-8). Each session lasts \~20 minutes, 3 sets of 10 reps with 1-minute rest. Participants receive instruction on proper technique and adherence is monitored online

BBAT GroupControl Group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18-45 years
  • Willing to participate in the study
  • Flexible pes planus (Navicular Drop ≥10 mm and positive Jack's Toe Raise Test)

You may not qualify if:

  • Pain in lower extremity joints
  • Obesity (BMI \>30)
  • Pregnancy
  • Systemic, neuromuscular, or neurological disorders
  • Posterior tibial tendon dysfunction (unable to perform heel-rise test)
  • History of lower limb surgery
  • Previous treatment for pes planus or use of foot orthoses
  • Lower extremity injury in past 6 months
  • Orthopedic conditions other than pes planus and mild hallux valgus (Manchester Scale C or D excluded)
  • Participation in regular exercise program in past 6 months
  • Prior personal experience with TBFT and/or short foot exercises

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mardin Artuklu University

Mardin, Mardi̇n, Turkey (Türkiye)

RECRUITING

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

Study Officials

  • Fatma Betül Yardımcı, MSc

    Mardin Artuklu University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatma Betül Yardımcı

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are randomly assigned to either the Control Group (Short Foot Exercises only) or the Experimental Group (BBAT + SFE) in parallel arms for comparison.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RESEARCH ASSISTANT

Study Record Dates

First Submitted

November 13, 2025

First Posted

November 14, 2025

Study Start

January 1, 2025

Primary Completion

November 1, 2025

Study Completion

December 1, 2025

Last Updated

November 17, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations