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临床试验/NCT07688785
NCT07688785招募中不适用

Effects of Basic Body Awareness Therapy on Spatiotemporal Gait Characteristics and Plantar Pressure Distribution in Healthy Young Adults

Hacettepe University1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2026年6月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
33
试验地点
1
主要终点
Change in Gait Speed

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

盲法说明

No masking will be used because all participants receive the same behavioral physiotherapy intervention and assessments are performed within a single-group repeated-measures design.

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Basic Body Awareness Therapy (Other)

结局指标

主要结局

Change in Gait Speed

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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: %

次要结局

  • Change in Static Plantar Load Distribution(Baseline, after 12 weeks of intervention, and 3 months after intervention completion.)
  • Change in Dynamic Plantar Pressure Distribution During Walking(Baseline, after 12 weeks of intervention, and 3 months after intervention completion.)
  • Therapy Adherence(Throughout the 12-week intervention period.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Özge ÇANKAYA

Principal Investigator

Hacettepe University

研究点 (1)

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