Toe Walking BehaviorsNCT07078214
Backward Walking Effects on Toe Walking in a Child With ASD: Single-Case Study
A study testing Foot Sole Surface Area Measurements and Walking Exercise Program and Implementation Process in people with Toe Walking Behaviors and Backward Walking, run by Giresun University at 1 site in Turkey (Türkiye).
Trial summary
This study tested the hypothesis that backward walking exercises can reduce Toe Walking Behaviors (TWB) in children with ASD and emphasized the importance of pedobarographic measurements for quantitative TWB assessment. Read more about this study
- Who is it for?
- Ages 3 years and older, women only
- Conditions the study is for
- Toe Walking Behaviors, Backward Walking
- What is being tested?
- Foot Sole Surface Area Measurements and Walking Exercise Program and Implementation Process
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Feb 2025to 15 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 3 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- It was required that the participant be diagnosed with ASD, exhibit TWB, be able to follow simple instructions, have no health problems other than ASD, and not have participated in any exercise program or physical therapy rehabilitation. It has been reported by orthopedic and physical therapy specialists, whom the parents had previously consulted, that the child exhibits TWB with ASD characteristics only, without any musculoskeletal problems.
Who cannot join
- Children with any musculoskeletal problems, diagnoses other than ASD (such as cerebral palsy, etc.), or those who had previously undergone surgical operations on the lower extremities were not included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Giresun University, Sport Science Faculty, Güre Campus
Giresun, Centre, 28100
About this study
Official title: The Effect of Backward Walking on Toe Walking Behaviors in a Child With Autism Spectrum Disorder: Single-participant (Subject) Experimental Research
This study tested the hypothesis that backward walking exercises can reduce Toe Walking Behaviors (TWB) in children with ASD and emphasized the importance of pedobarographic measurements for quantitative TWB assessment.
Read the detailed description
Study Description: Backward Walking Exercise Intervention for Toe Walking in Children with Autism Spectrum Disorder Study Overview This research study investigates whether backward walking exercises can help reduce toe walking behavior in young children with Autism Spectrum Disorder (ASD). Toe walking is a common movement pattern where children walk on their toes instead of using their whole foot, which can affect balance, coordination, and overall development.
Background and Importance Children with Autism Spectrum Disorder often develop unusual walking patterns, including toe walking, which can impact their physical development and daily activities. Traditional approaches to address this behavior have shown limited success, making it important to explore new, evidence-based interventions that can be easily implemented and monitored.
Study Design and Approach
This study uses a single-subject research design, which allows for detailed examination of individual responses to treatment. The research follows a structured A-B-A pattern:
Baseline Phase (1 week): Researchers measure the child's natural walking pattern without any intervention Implementation Phase (9 weeks): The child participates in backward walking exercises on a treadmill Monitoring Phase (1 week): Researchers observe whether improvements continue after stopping the exercises Participants The study focuses on young children (approximately 3-4 years old) who have been diagnosed with Autism Spectrum Disorder and demonstrate persistent toe walking behavior. Participant is carefully selected to ensure they can safely participate in treadmill-based exercises.
What the Study Involves Exercise Program: Children participate in backward walking exercises on a specially adapted treadmill, designed to be safe and appropriate for their developmental level. These sessions occur 5 days per week during the treatment phase.
Measurement Technology: The study uses advanced foot pressure measurement technology (pedobarographic analysis) to precisely track how much of the child's foot touches the ground during walking. This provides objective, quantitative data about walking patterns.
Monitoring and Safety: All activities are supervised by trained researchers and adapted to each child's individual needs and abilities.
Study Duration
The complete study spans 11 weeks:
Week 1: Baseline measurements Weeks 2-10: Backward walking exercise intervention Week 11: Follow-up monitoring Potential Benefits This research may help establish backward walking exercises as an effective, non-invasive intervention for addressing toe walking in children with ASD. The findings could contribute to improved physical therapy approaches and better developmental outcomes for children with autism.
Scientific Significance This study employs rigorous single-subject methodology following established research guidelines (SCRIBE) to ensure reliable and valid results. The use of objective measurement technology provides precise data that can help clinicians and families make informed decisions about treatment approaches.
- Conditions
- Toe Walking Behaviors, Backward Walking
- Being tested
- Foot Sole Surface Area Measurements, Walking Exercise Program and Implementation Process
- Keywords
- Autism, Backward walking, Toe walking
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot Sole Surface Area MeasurementsOther
The child's TWB was measured using the BTS P-Walk platform [2440x740x8 mm, 12,000 sensors] with an additional 500mm sensor-free mat for accurate start/end measurements. The system focused on foot-ground contact surface area data.Before measurements, the child familiarized herself with the platform through play. All walks were barefoot, with at least 3 attempts per assessment and the clearest data selected. To encourage platform crossing, the child carried a small object to her mother waiting opposite. To prevent upper extremity interference with gait, only return walks (without object) were analyzed for measurement.
Walking Exercise Program and Implementation ProcessOther
The backward walking exercise program was performed on a treadmill at 1±0.2 km/h speed, conducted 5 days per week between 14:00-15:00 hours when the child was most alert according to maternal reports. Initially planned for minimum 5-minute sessions with gradual increases, but the child's short attention span and unfamiliarity with backward walking limited sessions to 3 minutes during first two days. Favorite cartoons displayed via tablet during sessions successfully enabled gradual time increases. Week 1 progressed from 3-5 minutes daily. Weeks 2-5 showed progressive increases to 6-9 minutes with sessions increased to 2 daily, separated by 10-15 minute play breaks. From week 6 onwards, two 10±0.2 minute sessions continued daily. Starting week 3, sessions were restructured as 5 minutes backward + 1 minute forward + 2-7 minutes backward walking to combat attention deficits after 5 minutes, improving exercise efficiency.
| Study group | Role | What they receive |
|---|---|---|
| A child with ASD exhibiting TWB (pseudonym "Daisy") | Experimental | Intervention Type: Backward walking exercise (treadmill-based) Frequency: 5 days per week Duration: 9 weeks (intervention phase) Session duration: 10-12 minutes/session; 2 sessions Intensity: Adapted according to participant's developmental level and safety requirements Implementation setting: In a controlled laboratory environment, specially adapted treadmill Supervision: Continuous supervision by trained researchers Measurement: Plantar surface area measurement using pedobarographic analysis Safety protocol: Safety measures adapted to individual needs Receives: Other: Foot Sole Surface Area Measurements; Other: Walking Exercise Program and Implementation Process |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot Sole Surface Area Measurements
Toe walking behavior (TWB) was measured using the BTS P-Walk platform [2440x740x8 mm with 2400x500 mm sensorized area containing 12,000 sensors]. A 500 mm sensor-free mat was added at platform ends for accurate start/end measurements. The system focused on foot-ground contact surface area data relevant to this study's objectives. Before measurements, the child familiarized herself with the platform through play activities to ensure comfort. All assessments were conducted barefoot with at least three walks per session, selecting the clearest data for analysis. To encourage natural platform crossing, the child carried a small object to her mother waiting opposite. To prevent upper extremity interference with gait patterns, only return walks without the object were analyzed, ensuring accurate toe walking measurements unaffected by carrying tasks or arm movements during the assessment protocol. Changes assessed using visual analysis and statistical measures including ES calculations.
Measured: 11weeks (55 days)- 9 weeks of implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start3 Feb 2025
- Primary completion18 Apr 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Toe Walking BehaviorsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is a prospective research based on single-subject experimental design. Model A-B-A (Reversal Design) was preferred because it was desired that the provided benefit continue in favor of the child without interruption. In this design, the baseline level of the targeted behavior is determined, and during the implementation phase, the behavior is expected to gradually change toward the main goal, and the effects of the independent variable are monitored during a second baseline phase (withdrawal or monitoring). Additionally, the principles and instructions in the SCRIBE guidelines were taken into consideration in the design and implementation of this study. This guideline is a reporting manual for single-participant designs in behavioral interventions.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Giresun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ekrem AKBUGA, PhD, Giresun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07078214
- Sponsor's protocol ID
- GRU-SBF-EA-001
- Status last verified
- Jul 2025
- First submitted
- 28 Jun 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I do not want to share my data. I am sorry.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Backward Walking on Toe Walking Behaviors in a Child With Autism Spectrum Disorder: Single-participant (Subject) Experimental Research
- ClinicalTrials.gov ID
- NCT07078214
- Acronym / sponsor ID
- GRU-SBF-EA-001
- Conditions
- Toe Walking Behaviors, Backward Walking
- Keywords
- Autism, Backward walking, Toe walking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Giresun UniversityUniversity, hospital or other
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 18 Apr 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 22 Jul 2025 (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 study tested the hypothesis that backward walking exercises can reduce Toe Walking Behaviors (TWB) in children with ASD and emphasized the importance of pedobarographic measurements for quantitative TWB assessment.
Detailed description
Study Description: Backward Walking Exercise Intervention for Toe Walking in Children with Autism Spectrum Disorder Study Overview This research study investigates whether backward walking exercises can help reduce toe walking behavior in young children with Autism Spectrum Disorder (ASD). Toe walking is a common movement pattern where children walk on their toes instead of using their whole foot, which can affect balance, coordination, and overall development.
Background and Importance Children with Autism Spectrum Disorder often develop unusual walking patterns, including toe walking, which can impact their physical development and daily activities. Traditional approaches to address this behavior have shown limited success, making it important to explore new, evidence-based interventions that can be easily implemented and monitored.
Study Design and Approach
This study uses a single-subject research design, which allows for detailed examination of individual responses to treatment. The research follows a structured A-B-A pattern:
Baseline Phase (1 week): Researchers measure the child's natural walking pattern without any intervention Implementation Phase (9 weeks): The child participates in backward walking exercises on a treadmill Monitoring Phase (1 week): Researchers observe whether improvements continue after stopping the exercises Participants The study focuses on young children (approximately 3-4 years old) who have been diagnosed with Autism Spectrum Disorder and demonstrate persistent toe walking behavior. Participant is carefully selected to ensure they can safely participate in treadmill-based exercises.
What the Study Involves Exercise Program: Children participate in backward walking exercises on a specially adapted treadmill, designed to be safe and appropriate for their developmental level. These sessions occur 5 days per week during the treatment phase.
Measurement Technology: The study uses advanced foot pressure measurement technology (pedobarographic analysis) to precisely track how much of the child's foot touches the ground during walking. This provides objective, quantitative data about walking patterns.
Monitoring and Safety: All activities are supervised by trained researchers and adapted to each child's individual needs and abilities.
Study Duration
The complete study spans 11 weeks:
Week 1: Baseline measurements Weeks 2-10: Backward walking exercise intervention Week 11: Follow-up monitoring Potential Benefits This research may help establish backward walking exercises as an effective, non-invasive intervention for addressing toe walking in children with ASD. The findings could contribute to improved physical therapy approaches and better developmental outcomes for children with autism.
Scientific Significance This study employs rigorous single-subject methodology following established research guidelines (SCRIBE) to ensure reliable and valid results. The use of objective measurement technology provides precise data that can help clinicians and families make informed decisions about treatment approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a prospective research based on single-subject experimental design. Model A-B-A (Reversal Design) was preferred because it was desired that the provided benefit continue in favor of the child without interruption. In this design, the baseline level of the targeted behavior is determined, and during the implementation phase, the behavior is expected to gradually change toward the main goal, and the effects of the independent variable are monitored during a second baseline phase (withdrawal or monitoring). Additionally, the principles and instructions in the SCRIBE guidelines were taken into consideration in the design and implementation of this study. This guideline is a reporting manual for single-participant designs in behavioral interventions.
| Arm | Type | Receives |
|---|---|---|
| A child with ASD exhibiting TWB (pseudonym "Daisy") | Experimental | Other: Foot Sole Surface Area Measurements, Other: Walking Exercise Program and Implementation ProcessIntervention Type: Backward walking exercise (treadmill-based) Frequency: 5 days per week Duration: 9 weeks (intervention phase) Session duration: 10-12 minutes/session; 2 sessions Intensity: Adapted according to participant's developmental level and safety requirements Implementation setting: In a controlled laboratory environment, specially adapted treadmill Supervision: Continuous supervision by trained researchers Measurement: Plantar surface area measurement using pedobarographic analysis Safety protocol: Safety measures adapted to individual needs |
Who may qualify
- Ages
- 3 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- It was required that the participant be diagnosed with ASD, exhibit TWB, be able to follow simple instructions, have no health problems other than ASD, and not have participated in any exercise program or physical therapy rehabilitation. It has been reported by orthopedic and physical therapy specialists, whom the parents had previously consulted, that the child exhibits TWB with ASD characteristics only, without any musculoskeletal problems.
Key exclusion criteria (1 listed)
- Children with any musculoskeletal problems, diagnoses other than ASD (such as cerebral palsy, etc.), or those who had previously undergone surgical operations on the lower extremities were not included in the study.
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 |
|---|---|---|
| Foot Sole Surface Area MeasurementsThe child's TWB was measured using the BTS P-Walk platform [2440x740x8 mm, 12,000 sensors] with an additional 500mm sensor-free mat for accurate start/end measurements. The system focused on foot-ground contact surface area data.Before measurements, the child familiarized herself with the platform through play. All walks were barefoot, with at least 3 attempts per assessment and the clearest data selected. To encourage platform crossing, the child carried a small object to her mother waiting opposite. To prevent upper extremity interference with gait, only return walks (without object) were analyzed for measurement. | Other | A child with ASD exhibiting TWB (pseudonym "Daisy") |
| Walking Exercise Program and Implementation ProcessThe backward walking exercise program was performed on a treadmill at 1±0.2 km/h speed, conducted 5 days per week between 14:00-15:00 hours when the child was most alert according to maternal reports. Initially planned for minimum 5-minute sessions with gradual increases, but the child's short attention span and unfamiliarity with backward walking limited sessions to 3 minutes during first two days. Favorite cartoons displayed via tablet during sessions successfully enabled gradual time increases. Week 1 progressed from 3-5 minutes daily. Weeks 2-5 showed progressive increases to 6-9 minutes with sessions increased to 2 daily, separated by 10-15 minute play breaks. From week 6 onwards, two 10±0.2 minute sessions continued daily. Starting week 3, sessions were restructured as 5 minutes backward + 1 minute forward + 2-7 minutes backward walking to combat attention deficits after 5 minutes, improving exercise efficiency. | Other | A child with ASD exhibiting TWB (pseudonym "Daisy") |
Primary outcome
Foot Sole Surface Area Measurements
Time frame: 11weeks (55 days)- 9 weeks of implementation
Toe walking behavior (TWB) was measured using the BTS P-Walk platform [2440x740x8 mm with 2400x500 mm sensorized area containing 12,000 sensors]. A 500 mm sensor-free mat was added at platform ends for accurate start/end measurements. The system focused on foot-ground contact surface area data relevant to this study's objectives. Before measurements, the child familiarized herself with the platform through play activities to ensure comfort. All assessments were conducted barefoot with at least three walks per session, selecting the clearest data for analysis. To encourage natural platform crossing, the child carried a small object to her mother waiting opposite. To prevent upper extremity interference with gait patterns, only return walks without the object were analyzed, ensuring accurate toe walking measurements unaffected by carrying tasks or arm movements during the assessment protocol. Changes assessed using visual analysis and statistical measures including ES calculations.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Individual participant dataSharing planned: No. I do not want to share my data. I am sorry.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foot Sole Surface Area Measurements and Walking Exercise Program and Implementation Process in people with Toe Walking Behaviors and Backward Walking, run by Giresun 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 22 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot Sole Surface Area Measurements (time frame: 11weeks (55 days)- 9 weeks of implementation). 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 22 Jul 2025.