University of Health Sciences
Ankara, 06100, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07688785
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.
Interested in participating?
Request Info18 year–25 year
All sexes
Interventional
Not applicable
Ankara, 06100, Turkey (Türkiye)
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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
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
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
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
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: %
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: %
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: %
Time frame: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
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.
Time frame: Baseline, after 12 weeks of intervention, and 3 months after intervention completion.
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
Time frame: Throughout the 12-week intervention period.
Attendance will be monitored using session attendance records. Therapy adherence will be defined as participation in at least 80% of planned BBAT sessions.
Contact information is provided by the study sponsor or research team.
Hacettepe University
Other
Effects of Basic Body Awareness Therapy on Spatiotemporal Gait Characteristics and Plantar Pressure Distribution in Healthy Young Adults
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