- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07688785
Effects of Basic Body Awareness Therapy on Gait and Plantar Pressure in Healthy Young Adults
Effects of Basic Body Awareness Therapy on Spatiotemporal Gait Characteristics and Plantar Pressure Distribution in Healthy Young Adults
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Özge ÇANKAYA, PhD
- Phone Number: +905053732255
- Email: ozgemuezzinoglu@gmail.com
Study Locations
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Ankara, Turkey (Türkiye), 06100
- University of Health Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental: Basic Body Awareness Therapy-BBAT Group
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Gait Speed
Time Frame: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
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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.
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Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
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Change in Cadence
Time Frame: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
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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 |
Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
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|
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 |
Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
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Change in Step Time
Time Frame: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
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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 |
Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
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Change in Stride Time
Time Frame: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
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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 |
Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
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Change in Stance Phase Duration
Time Frame: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
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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: % |
Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
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Change in Swing Phase Duration
Time Frame: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
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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: % |
Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
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Change in Gait Asymmetry Index
Time Frame: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
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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: % |
Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Static Plantar Load Distribution
Time Frame: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
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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.
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Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
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Change in Dynamic Plantar Pressure Distribution During Walking
Time Frame: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
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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
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Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
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Therapy Adherence
Time Frame: Throughout the 12-week intervention period.
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Attendance will be monitored using session attendance records.
Therapy adherence will be defined as participation in at least 80% of planned BBAT sessions.
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Throughout the 12-week intervention period.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Özge ÇANKAYA, PhD, Saglik Bilimleri Universitesi
- Study Director: Nilufer Keskin Dilbay, PhD, Saglik Bilimleri Universitesi
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2026/144
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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