- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07229079
The Effectiveness of Basic Body Awareness Therapy in Individuals With Pes Planus
November 14, 2025 updated by: Fatma Betül YARDIMCI, Mardin Artuklu University
The Effectiveness of Basic Body Awareness Therapy Combined With Short Foot Exercises in Individuals With Pes Planus
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Pes planus is a common orthopedic condition characterized by the collapse of the medial longitudinal arch of the foot, which negatively affects lower extremity biomechanics, postural stability, and balance.
Currently, interventions targeting muscle activation-such as short foot exercises (SFE)-are widely used in the management of pes planus.
However, it is believed that holistic approaches incorporating sensory input and body awareness may further enhance functional outcomes in these individuals.
Basic Body Awareness Therapy (BBAT) is a physiotherapeutic method designed to improve movement quality, balance, and posture.
In this study, BBAT will be applied for the first time in individuals with pes planus.
This project aims to investigate the effects of BBAT, when combined with SFE, on medial longitudinal arch height, foot function, gait, balance, proprioception, plantar sensation, and body awareness in individuals with pes planus.
The study will be conducted as a randomized controlled trial.
Fifty participants who meet the inclusion criteria will be randomly assigned into two groups of 25: a BBAT group (SFE + BBAT) and a control group (SFE only).
Interventions will be administered twice a week for a duration of eight weeks.
Assessments will be conducted at three time points: before the intervention, immediately after the eight-week intervention period, and two months post-intervention (follow-up).
This study aims to demonstrate that BBAT can provide significant improvements in both somatic and sensory parameters in individuals with pes planus, offering a holistic complement to traditional exercise-based approaches.
In doing so, it is expected to contribute an innovative perspective to clinical physiotherapy practices and address a significant gap in the existing literature.
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Fatma Betül Yardımcı
- Phone Number: +905063196665
- Email: fatmabetulyardimci@gmail.com
Study Contact Backup
- Name: Bahar Anaforoglu
- Phone Number: +905057421220
- Email: anaforoglub@hotmail.com
Study Locations
-
-
Mardi̇n
-
Mardin, Mardi̇n, Turkey (Türkiye)
- Recruiting
- Mardin Artuklu University
-
Contact:
- fatma betül yardımcı
- Phone Number: 05063196665
- Email: fatmabetulyardimci@gmail.com
-
Contact:
- bahar anaforoglu
- Email: anaforoglub@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Aged 18-45 years
- Willing to participate in the study
- Flexible pes planus (Navicular Drop ≥10 mm and positive Jack's Toe Raise Test)
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: BBAT Group
Participants will receive Short Foot Exercises (SFE) plus Basic Body Awareness Therapy (BBAT).
|
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.
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
|
|
Active Comparator: Control Group
Participants will receive only Short Foot Exercises (SFE).
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Navicular Drop Test
Time Frame: Baseline (pre-intervention), post-intervention (8 weeks), follow-up (2 months after intervention)
|
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
Time Frame: Baseline, post-intervention (8 weeks), follow-up (2 months)
|
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
Time Frame: Baseline, post-intervention (8 weeks), follow-up (2 months)
|
Active and passive joint position sense of the ankle measured with digital goniometer.
Eyes closed; angular error from target angle recorded.
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Baseline, post-intervention (8 weeks), follow-up (2 months)
|
|
Light Touch Sensation
Time Frame: Baseline, post-intervention (8 weeks), follow-up (2 months)
|
Semmes-Weinstein Monofilament Test at seven foot reference points.
Threshold of sensation recorded.
|
Baseline, post-intervention (8 weeks), follow-up (2 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Static Balance
Time Frame: Baseline, post-intervention (8 weeks), follow-up (2 months)
|
Flamingo Balance Test.
Participant stands on one leg on a narrow beam for 1 minute; balance errors recorded.
|
Baseline, post-intervention (8 weeks), follow-up (2 months)
|
|
Gait Performance
Time Frame: Baseline, post-intervention (8 weeks), follow-up (2 months)
|
10-Meter Walk Test performed at comfortable walking speed.
Time recorded and averaged over three trials.
|
Baseline, post-intervention (8 weeks), follow-up (2 months)
|
|
Body Awareness
Time Frame: Baseline, post-intervention (8 weeks), follow-up (2 months)
|
Body Awareness Questionnaire assessing participant's perception of bodily sensations and processes.
Score range 18-126; higher scores indicate better awareness.
|
Baseline, post-intervention (8 weeks), follow-up (2 months)
|
|
Foot Function Index - Pain Subscale
Time Frame: Baseline, post-intervention (8 weeks), follow-up (2 months)
|
The Pain subscale of the Foot Function Index (FFI) assesses foot pain during daily activities.
It includes 9 items rated on a 0-10 Likert-type scale.
Higher scores indicate worse pain.self-rate
23 items using a visual analog scale.
|
Baseline, post-intervention (8 weeks), follow-up (2 months)
|
|
Foot Function Index - Disability Subscale
Time Frame: Baseline, post-intervention (8 weeks), follow-up (2 months)
|
The Disability subscale of the Foot Function Index (FFI) evaluates difficulty in performing functional activities.
It contains 9 items scored on a 0-10 Likert-type scale.
Higher scores indicate greater disability.
|
Baseline, post-intervention (8 weeks), follow-up (2 months)
|
|
Foot Function Index - Activity Limitation Subscale
Time Frame: Baseline, post-intervention (8 weeks), follow-up (2 months)
|
The Activity Limitation subscale of the Foot Function Index (FFI) measures limitations in essential daily activities.
It consists of 5 items rated on a 0-10 Likert-type scale.
Higher scores indicate greater activity limitation.
|
Baseline, post-intervention (8 weeks), follow-up (2 months)
|
|
Foot Function Index - Total Score
Time Frame: Baseline, post-intervention (8 weeks), follow-up (2 months)
|
The Total Score of the Foot Function Index (FFI) is calculated by combining all pain, disability, and activity limitation items (23 items in total).
Each item is rated on a 0-10 Likert-type scale.
The total score reflects the overall foot-related functional status, with higher scores indicating worse function.
|
Baseline, post-intervention (8 weeks), follow-up (2 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Fatma Betül Yardımcı, MSc, Mardin Artuklu University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2025
Primary Completion (Estimated)
November 1, 2025
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
November 13, 2025
First Submitted That Met QC Criteria
November 13, 2025
First Posted (Estimated)
November 14, 2025
Study Record Updates
Last Update Posted (Actual)
November 17, 2025
Last Update Submitted That Met QC Criteria
November 14, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Talipes
- Musculoskeletal Diseases
- Musculoskeletal Abnormalities
- Congenital Abnormalities
- Lower Extremity Deformities, Congenital
- Limb Deformities, Congenital
- Foot Deformities
- Foot Deformities, Acquired
- Foot Deformities, Congenital
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Flatfoot
Other Study ID Numbers
- FBYDRTEZ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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