GaitNCT07688785
Effects of Basic Body Awareness Therapy on Gait and Plantar Pressure in Healthy Young Adults
A study testing Basic Body Awareness Therapy in people with Gait and Body Awareness, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This interventional study will evaluate the effects of Basic Body Awareness Therapy (BBAT) on gait and plantar pressure outcomes in healthy young adults. Participants aged 18 to 25 years will receive a 12-week BBAT program delivered twice weekly by a physiotherapist trained in BBAT. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Gait, Body Awareness
- What is being tested?
- Basic Body Awareness Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Jun 2026to 4 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18 to 25 years
- Able to walk independently
- No history of lower-extremity, spine, or balance-affecting trauma and/or surgery within the last 6 months
- Not receiving regular Basic Body Awareness Therapy
- Provides written informed consent
Who cannot join
- History of neurological, vestibular, or rheumatological disease
- Acute musculoskeletal injury
- Serious visual or hearing impairment
- Pain, deformity, or assistive device use that may affect walking performance
- Participation in a physiotherapy program and/or regular exercise program within the last 6 months
- Any condition preventing regular participation in assessment or therapy sessions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
University of Health Sciences
Ankara, 06100
Özge Çankaya, +905053732255, ozgemuezzinoglu@gmail.com
About this study
Official title: Effects of Basic Body Awareness Therapy on Spatiotemporal Gait Characteristics and Plantar Pressure Distribution in Healthy Young Adults
This interventional study will evaluate the effects of Basic Body Awareness Therapy (BBAT) on gait and plantar pressure outcomes in healthy young adults. Participants aged 18 to 25 years will receive a 12-week BBAT program delivered twice weekly by a physiotherapist trained in BBAT. Outcomes will be assessed at baseline, after the 12-week intervention, and at 3-month follow-up. The primary aim is to determine changes in gait speed and other spatiotemporal gait parameters during the 10-meter walk test. Secondary aims are to examine changes in static and dynamic plantar load distribution, right-left load sharing, and regional plantar pressure parameters. The study hypothesizes that BBAT will improve gait speed, reduce right-left differences in spatiotemporal gait parameters, improve bilateral load distribution during static stance and walking, and maintain these gains at 3-month follow-up.
Read the detailed description
Gait is a functional task requiring integrated postural control, sensorimotor processing, muscle coordination, and adaptation to the environment. Gait speed and related spatiotemporal parameters are sensitive indicators of functional status and movement capacity. Body awareness refers to the conscious perception and regulation of posture, movement quality, proprioceptive input, and interoceptive sensations. Basic Body Awareness Therapy is a physiotherapy-based mind-body approach that focuses on posture, balance, coordination, breathing, weight transfer, trunk control, and movement quality.
This study is designed as a single-group, quasi-experimental interventional study with repeated assessments. After completion of the informed consent process, demographic and health-related data will be collected. Gait and static stance measurements will be performed using Noraxon Ultium instrumented insoles. For static stance, participants will stand comfortably on both feet for one minute while plantar load distribution and right-left weight sharing are recorded. Participants will then complete the 10-meter walk test at maximum walking speed. Plantar loading data, including pressure distribution, step length, step time, stance and swing phases, and regional plantar pressure variables, will be processed using MyoResearch 3.16 software. The gait cycle will be normalized to 100%, divided into stance and swing phases, and plantar regions will be analyzed as heel, arch/midfoot, metatarsal, and toe segments.
The BBAT intervention will be delivered for 12 weeks, twice per week, with each session lasting approximately 45 to 60 minutes. Sessions will be supervised by a physiotherapist who has completed BBAT Level C training. The program will consist of low-intensity exercises focusing on awareness of contact with the floor, postural alignment, breathing and movement integration, weight transfer, trunk control, balance, and fluent movement quality. Therapy adherence will be monitored using attendance records, and adherence will be defined as participation in at least 80% of planned sessions. Measurements will be repeated after the 12-week intervention and 3 months after intervention completion to assess short-term effects and early maintenance of behavioral change.
The sample size was determined using G*Power 3.1 software. Considering the single-group design with three repeated measurements (pre-test, post-test at week 12, and 3-month follow-up), the parameters were set as a medium effect size of f = 0.25, an alpha error probability of 0.05, a power (1-β) of 0.80, a correlation among repeated measures of 0.50, and a non-sphericity correction ε = 1.00. Based on these parameters, the required sample size was calculated as 28 participants. Considering a possible dropout/follow-up loss rate of approximately 15%, the target sample size was determined as 33 participants.
- Conditions
- Gait, Body Awareness
- Being tested
- Basic Body Awareness Therapy
- Keywords
- Basic body awareness therapy, healthy young adult, Gait Analysis, plantar pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic Body Awareness TherapyOther
The Basic Body Awareness Therapy program includes low-intensity physiotherapy exercises focused on awareness of contact with the floor, postural alignment, breathing-movement integration, weight transfer, trunk control, balance, and fluent movement quality.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Basic Body Awareness Therapy-BBAT Group | Experimental | Participants will receive a 12-week BBAT program, two sessions per week, with each session lasting approximately 45-60 minutes. Sessions will be supervised by a physiotherapist trained in BBAT. Receives: Other: Basic Body Awareness Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gait Speed
Gait speed will be assessed during the 10-meter walk test using Noraxon Ultium instrumented insoles. Participants will be instructed to walk at maximum walking speed on a 10-meter walkway. The best test performance will be used for analysis. The metric will be recorded in meters/second.
Measured: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
Change in Cadence
Cadence will be assessed during the 10-meter walk test using Noraxon Ultium instrumented insoles and processed using MyoResearch 3.16. Cadence will be recorded as the number of steps per minute.
Unit of Measure: steps/min
Measured: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
Change in Step Length
Step length will be assessed during the 10-meter walk test using Noraxon Ultium instrumented insoles and processed using MyoResearch 3.16. Step length will be recorded in meters.
Unit of Measure: m
Measured: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
Change in Step Time
Step time will be assessed during the 10-meter walk test using Noraxon Ultium instrumented insoles and processed using MyoResearch 3.16. Step time will be recorded in seconds.
Unit of Measure: s
Measured: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
Change in Stride Time
Stride time will be assessed during the 10-meter walk test using Noraxon Ultium instrumented insoles and processed using MyoResearch 3.16. Stride time will be recorded in seconds.
Unit of Measure: s
Measured: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
Change in Stance Phase Duration
Stance phase duration will be assessed during the 10-meter walk test using Noraxon Ultium instrumented insoles and processed using MyoResearch 3.16. Stance phase duration will be recorded as a percentage of the gait cycle.
Unit of Measure: %
Measured: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
Change in Swing Phase Duration
Swing phase duration will be assessed during the 10-meter walk test using Noraxon Ultium instrumented insoles and processed using MyoResearch 3.16. Swing phase duration will be recorded as a percentage of the gait cycle.
Unit of Measure: %
Measured: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
Change in Gait Asymmetry Index
The asymmetry index for gait-phase timing parameters will be calculated using the formula:
AI = [(Right - Left) / ((Right + Left)/2)] × 100
The asymmetry index will be expressed as a percentage, with higher values indicating greater gait asymmetry.
Unit of Measure: %
Measured: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
Secondary outcomes (3)
Change in Static Plantar Load Distribution
Static plantar load distribution will be assessed during one minute of comfortable bipedal standing using Noraxon Ultium instrumented insoles. Outcomes will include right-left load sharing and regional plantar pressure/load parameters.
Measured: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
Change in Dynamic Plantar Pressure Distribution During Walking
Dynamic plantar pressure variables will be recorded during the 10-meter walk test. Plantar regions will be analyzed as heel, arch/midfoot, metatarsal, and toe segments. Variables will include regional pressure distribution and bilateral differences in plantar loading
Measured: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
Therapy Adherence
Attendance will be monitored using session attendance records. Therapy adherence will be defined as participation in at least 80% of planned BBAT sessions.
Measured: Throughout the 12-week intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start29 Jun 2026
- Primary completion29 Sep 2026 (estimated)
- Study completion4 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GaitStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm, quasi-experimental intervention study with repeated measures at baseline, after a 12-week BBAT program, and at 3-month follow-up.
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi
- Responsible party
- Principal investigator, Özge ÇANKAYA, Hacettepe University
- Investigators
- Özge ÇANKAYA, PhD, Principal investigator, Saglik Bilimleri UniversitesiNilufer Keskin Dilbay, PhD, Study director, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07688785
- Sponsor's protocol ID
- 2026/144
- Status last verified
- Jul 2026
- First submitted
- 26 Jun 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Basic Body Awareness Therapy on Spatiotemporal Gait Characteristics and Plantar Pressure Distribution in Healthy Young Adults
- ClinicalTrials.gov ID
- NCT07688785
- Acronym / sponsor ID
- 2026/144
- Conditions
- Gait, Body Awareness
- Keywords
- Basic body awareness therapy, healthy young adult, Gait Analysis, plantar pressure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi
- Study start
- 29 Jun 2026 (actual)
- Primary completion
- 29 Sep 2026 (estimated)
- Study completion
- 4 Jan 2027 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This interventional study will evaluate the effects of Basic Body Awareness Therapy (BBAT) on gait and plantar pressure outcomes in healthy young adults. Participants aged 18 to 25 years will receive a 12-week BBAT program delivered twice weekly by a physiotherapist trained in BBAT. Outcomes will be assessed at baseline, after the 12-week intervention, and at 3-month follow-up. The primary aim is to determine changes in gait speed and other spatiotemporal gait parameters during the 10-meter walk test. Secondary aims are to examine changes in static and dynamic plantar load distribution, right-left load sharing, and regional plantar pressure parameters. The study hypothesizes that BBAT will improve gait speed, reduce right-left differences in spatiotemporal gait parameters, improve bilateral load distribution during static stance and walking, and maintain these gains at 3-month follow-up.
Detailed description
Gait is a functional task requiring integrated postural control, sensorimotor processing, muscle coordination, and adaptation to the environment. Gait speed and related spatiotemporal parameters are sensitive indicators of functional status and movement capacity. Body awareness refers to the conscious perception and regulation of posture, movement quality, proprioceptive input, and interoceptive sensations. Basic Body Awareness Therapy is a physiotherapy-based mind-body approach that focuses on posture, balance, coordination, breathing, weight transfer, trunk control, and movement quality.
This study is designed as a single-group, quasi-experimental interventional study with repeated assessments. After completion of the informed consent process, demographic and health-related data will be collected. Gait and static stance measurements will be performed using Noraxon Ultium instrumented insoles. For static stance, participants will stand comfortably on both feet for one minute while plantar load distribution and right-left weight sharing are recorded. Participants will then complete the 10-meter walk test at maximum walking speed. Plantar loading data, including pressure distribution, step length, step time, stance and swing phases, and regional plantar pressure variables, will be processed using MyoResearch 3.16 software. The gait cycle will be normalized to 100%, divided into stance and swing phases, and plantar regions will be analyzed as heel, arch/midfoot, metatarsal, and toe segments.
The BBAT intervention will be delivered for 12 weeks, twice per week, with each session lasting approximately 45 to 60 minutes. Sessions will be supervised by a physiotherapist who has completed BBAT Level C training. The program will consist of low-intensity exercises focusing on awareness of contact with the floor, postural alignment, breathing and movement integration, weight transfer, trunk control, balance, and fluent movement quality. Therapy adherence will be monitored using attendance records, and adherence will be defined as participation in at least 80% of planned sessions. Measurements will be repeated after the 12-week intervention and 3 months after intervention completion to assess short-term effects and early maintenance of behavioral change.
The sample size was determined using G*Power 3.1 software. Considering the single-group design with three repeated measurements (pre-test, post-test at week 12, and 3-month follow-up), the parameters were set as a medium effect size of f = 0.25, an alpha error probability of 0.05, a power (1-β) of 0.80, a correlation among repeated measures of 0.50, and a non-sphericity correction ε = 1.00. Based on these parameters, the required sample size was calculated as 28 participants. Considering a possible dropout/follow-up loss rate of approximately 15%, the target sample size was determined as 33 participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, quasi-experimental intervention study with repeated measures at baseline, after a 12-week BBAT program, and at 3-month follow-up.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Basic Body Awareness Therapy-BBAT Group | Experimental | Other: Basic Body Awareness TherapyParticipants will receive a 12-week BBAT program, two sessions per week, with each session lasting approximately 45-60 minutes. Sessions will be supervised by a physiotherapist trained in BBAT. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged 18 to 25 years
- Able to walk independently
- No history of lower-extremity, spine, or balance-affecting trauma and/or surgery within the last 6 months
- Not receiving regular Basic Body Awareness Therapy
- Provides written informed consent
Key exclusion criteria (6 listed)
- History of neurological, vestibular, or rheumatological disease
- Acute musculoskeletal injury
- Serious visual or hearing impairment
- Pain, deformity, or assistive device use that may affect walking performance
- Participation in a physiotherapy program and/or regular exercise program within the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Basic Body Awareness TherapyThe Basic Body Awareness Therapy program includes low-intensity physiotherapy exercises focused on awareness of contact with the floor, postural alignment, breathing-movement integration, weight transfer, trunk control, balance, and fluent movement quality. | Other | Experimental: Basic Body Awareness Therapy-BBAT Group |
Primary outcome
Change in Gait Speed
Time frame: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
Gait speed will be assessed during the 10-meter walk test using Noraxon Ultium instrumented insoles. Participants will be instructed to walk at maximum walking speed on a 10-meter walkway. The best test performance will be used for analysis. The metric will be recorded in meters/second.
Change in Cadence
Time frame: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
Cadence will be assessed during the 10-meter walk test using Noraxon Ultium instrumented insoles and processed using MyoResearch 3.16. Cadence will be recorded as the number of steps per minute. Unit of Measure: steps/min
Change in Step Length
Time frame: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
Step length will be assessed during the 10-meter walk test using Noraxon Ultium instrumented insoles and processed using MyoResearch 3.16. Step length will be recorded in meters. Unit of Measure: m
Change in Step Time
Time frame: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
Step time will be assessed during the 10-meter walk test using Noraxon Ultium instrumented insoles and processed using MyoResearch 3.16. Step time will be recorded in seconds. Unit of Measure: s
Change in Stride Time
Time frame: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
Stride time will be assessed during the 10-meter walk test using Noraxon Ultium instrumented insoles and processed using MyoResearch 3.16. Stride time will be recorded in seconds. Unit of Measure: s
Change in Stance Phase Duration
Time frame: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
Stance phase duration will be assessed during the 10-meter walk test using Noraxon Ultium instrumented insoles and processed using MyoResearch 3.16. Stance phase duration will be recorded as a percentage of the gait cycle. Unit of Measure: %
Change in Swing Phase Duration
Time frame: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
Swing phase duration will be assessed during the 10-meter walk test using Noraxon Ultium instrumented insoles and processed using MyoResearch 3.16. Swing phase duration will be recorded as a percentage of the gait cycle. Unit of Measure: %
Change in Gait Asymmetry Index
Time frame: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
The asymmetry index for gait-phase timing parameters will be calculated using the formula: AI = [(Right - Left) / ((Right + Left)/2)] × 100 The asymmetry index will be expressed as a percentage, with higher values indicating greater gait asymmetry. Unit of Measure: %
3 secondary outcomes
Change in Static Plantar Load Distribution
Time frame: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
Change in Dynamic Plantar Pressure Distribution During Walking
Time frame: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
Therapy Adherence
Time frame: Throughout the 12-week intervention period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Özge ÇANKAYA, PhD principal investigator
Saglik Bilimleri Universitesi
Nilufer Keskin Dilbay, PhD study director
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Basic Body Awareness Therapy in people with Gait and Body Awareness, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Özge ÇANKAYA, PhD (+905053732255, ozgemuezzinoglu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gait Speed (time frame: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.