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

NCT07688785 | Recruiting

• 1 other identifier: 2026/144
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Gait; Body Awareness

Keywords

Basic body awareness therapy; healthy young adult; Gait Analysis; plantar pressure

Outcome Measures

Primary Outcomes (8)

• 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.

  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

  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

  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

  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

  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: %

  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: %

  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: %

  Baseline, after 12 weeks of intervention, and 3 months after intervention completion.

Secondary Outcomes (3)

• 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.

Study Arms (1)

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.

Other: Basic Body Awareness Therapy

Interventions

Basic Body Awareness Therapy OTHER

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.

Experimental: Basic Body Awareness Therapy-BBAT Group

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead
• Saglik Bilimleri Universitesi: collaborator

Study Sites (1)

University of Health Sciences

Ankara, 06100, Turkey (Türkiye)

RECRUITING

Study Officials

• Özge ÇANKAYA, PhD

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

• Nilufer Keskin Dilbay, PhD

  Saglik Bilimleri Universitesi

  STUDY DIRECTOR

Central Study Contacts

Özge ÇANKAYA, PhD

CONTACT

+905053732255; ozgemuezzinoglu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single-arm, quasi-experimental intervention study with repeated measures at baseline, after a 12-week BBAT program, and at 3-month follow-up.

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 7, 2026
• Study Start: June 29, 2026
• Primary Completion (Estimated): September 29, 2026
• Study Completion (Estimated): January 4, 2027
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)