Autism Spectrum DisorderNCT06893718
Treadmill Training With and Without Compression Stockings on Toe Walking and Balance in Children With Autism.
A study testing Compressions Stocking Group and Treadmill Training Group in people with Autism Spectrum Disorder, run by Riphah International University at 1 site in Pakistan.
Trial summary
Autism Spectrum Disorder (ASD) affects around 1.7% of US children, with co-occurring conditions like ADHD, anxiety, and epilepsy complicating daily functioning. Early intervention strategies, such as sensory-based therapies and physical exercises like treadmill training, are used to improve motor skills and overall… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Compressions Stocking Group and Treadmill Training Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Mar 2025to 12 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with ASD who toe walk.
- Gait disorder more than 30% of the time.
- Compliance with our treatment protocol.
- Children whose guardians agreed on the study
Who cannot join
- Associated orthopedic conditions.
- Underlying genetic disorders.
- Global developmental delay.
- Patient's parents'/guardians' refusal to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Muhammad Asif Javed
Lahore, Punjab Province, 54000
Muhammad Asif Javed, MS-PT(Neuro), 923224209422, a.javed@riphah.edu.pk
About this study
Official title: Effects of Treadmill Training With and Without Compression Stockings on Toe Walking and Balance in Children With Autism.
Autism Spectrum Disorder (ASD) affects around 1.7% of US children, with co-occurring conditions like ADHD, anxiety, and epilepsy complicating daily functioning. Early intervention strategies, such as sensory-based therapies and physical exercises like treadmill training, are used to improve motor skills and overall functioning in children with ASD. A randomized controlled trial is being conducted to evaluate the impact of treadmill interventions on children with toe-walking behaviors. Participants will be assigned to either Group A or Group B, with treadmill sessions with or without compression stockings. The study aims to investigate the potential benefits of treadmill therapy as part of a multidisciplinary approach to treating ASD.
Read the detailed description
Autism spectrum disorder (ASD) is a complex neurodevelopmental condition characterized by difficulties in social communication, repetitive behaviors, and sensory sensitivities, typically appearing early in life. The disorder's prevalence varies globally, with recent estimates in the US showing approximately 1.7% of children affected. Diagnosis relies on comprehensive evaluations using standardized tools, such as the Autism Diagnostic Observation Schedule, to assess behavioral patterns and developmental history. Individuals with ASD often experience cooccurring conditions like ADHD, anxiety, and epilepsy, which can further impact daily functioning. Motor abnormalities, including toe-walking, are observed in some cases and may indicate underlying neurological issues or developmental delays. Early intervention, including sensory-based therapies and physical exercises like treadmill training, aims to improve motor skills and overall functioning in children with ASD, highlighting the importance of multidisciplinary support for optimal developmental outcomes.
The study will be a Randomized Controlled Trial (RCT) designed to investigate the impact of treadmill interventions on children with autism spectrum disorder (ASD) who exhibit toe-walking behaviors. Legal guardians will receive comprehensive information about the research objectives, methods, and potential benefits, and informed consent will be obtained prior to participation. Initial assessments will thoroughly evaluate each participant's baseline strength, frequency of toe walking, and balance using standardized tools like the 50-foot walk test for toe walking and the Pediatric Balance Scale for balance assessment. Participants meeting specific inclusion criteria: children diagnosed with ASD, displaying toe walking more than 30% of the time, and compliant with the treatment protocol and Exclusion Criteria: Associated orthopedic conditions, underlying genetic disorders, global developmental delay, patient's parents'/guardians' refusal to provide informed consent will be assigned to either Group A or Group B by Non- Probability Convenient Sampling technique. Group A will undergo treadmill sessions while wearing compression stockings for one hour before and during a 10-minute treadmill walk, with incline adjustments from 10% to 12% over six weeks. Group B will undergo identical treadmill sessions without compression stockings. The study will be conducted in a controlled environment at a single autism center, ensuring consistent conditions for both groups. IBM SPSS Statistics version 27 will be used for data analysis.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Compressions Stocking Group, Treadmill Training Group
- Keywords
- "Autism, Toe Walking, Treadmill, Compression Stockings.
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compressions Stocking GroupOther
- Incline: Initially 5% incline and after 4 weeks an incline of 10% will be observed
- Speed: Constant speed of 3.4 mph.
- Warm up: Calf stretch 10 reps/ 2 sets.
Treadmill Training GroupOther
- Incline: Initially 5% incline and after 4 weeks an incline of 10% will be observed
- Speed: Constant speed of 3.4 mph.
- Warm up: Calf stretch 10 reps/ 2 sets.
| Study group | Role | What they receive |
|---|---|---|
| Group A intervention: Compressions Stocking Group | Experimental | * Duration:
* Stockings for 1 hour before and during treadmill walking.
* Treadmill for 10 minutes.
* Frequency: 5 sessions/ week for 6 weeks. Receives: Other: Compressions Stocking Group; Other: Treadmill Training Group |
| Group B intervention: Treadmill Training Group | Active comparator | Duration: Treadmill for 10 minutes.
• Frequency: 5 sessions/ week for 6 weeks. Receives: Other: Compressions Stocking Group; Other: Treadmill Training Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Balance Scale
The 14-item Pediatric Balance Scale (PBS) is a tool used to assess children's functional balance. The PBS was created by altering the Berg Balance Scale (BBS) to be used with children with cerebral palsy (CP) who have trouble responding to external stimuli and maintaining their posture. For kids with mild to severe motor impairments, the PBS has been further refined as a balancing assessment tool.
Measured: baseline, 3rd week, 6th week.
Toe Walking
Trials frequently use the 50-Foot Timed Walk (50FTW) as a gait assessment tool. Initially, exercise-based research was the main application of the 50FWT. Around 15.24 meters (50 feet) away, the participants walk a straight line at their typical walking pace. A fat, colored tape was used to measure a distance of 15.24 meters to chart the course.
Measured: baseline, 3rd week, 6th week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start15 Mar 2025
- Primary completion28 Apr 2025 (estimated)
- Study completion12 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qutbia Abaq Javed Cheema, MS-PPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06893718
- Sponsor's protocol ID
- REC/RCR/AHS/25/qutbia abaq
- Status last verified
- Mar 2025
- First submitted
- 19 Mar 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dehghani M, Jafarnezhadgero AA, Darvishani MA, Aali S, Granacher U. Effects of an 8-week multimodal exercise program on ground reaction forces and plantar pressure during walking in boys with autism spectrum disorder. Trials. 2023 Mar 8;24(1):170. doi: 10.1186/s13063-023-07158-7.
PubMed 36890589Grandits JB, Kent HW, Sanborn SM, Pilcher JJ. The effect of compression on repetitive behaviors and task participation in children with autism spectrum disorder. Front Psychol. 2023 Dec 13;14:1292439. doi: 10.3389/fpsyg.2023.1292439. eCollection 2023.
PubMed 38162972
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Treadmill Training With and Without Compression Stockings on Toe Walking and Balance in Children With Autism.
- ClinicalTrials.gov ID
- NCT06893718
- Acronym / sponsor ID
- REC/RCR/AHS/25/qutbia abaq
- Conditions
- Autism Spectrum Disorder
- Keywords
- "Autism, Toe Walking, Treadmill, Compression Stockings.
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 28 Apr 2025 (estimated)
- Study completion
- 12 May 2025 (estimated)
- First posted
- 25 Mar 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.
Autism Spectrum Disorder (ASD) affects around 1.7% of US children, with co-occurring conditions like ADHD, anxiety, and epilepsy complicating daily functioning. Early intervention strategies, such as sensory-based therapies and physical exercises like treadmill training, are used to improve motor skills and overall functioning in children with ASD. A randomized controlled trial is being conducted to evaluate the impact of treadmill interventions on children with toe-walking behaviors. Participants will be assigned to either Group A or Group B, with treadmill sessions with or without compression stockings. The study aims to investigate the potential benefits of treadmill therapy as part of a multidisciplinary approach to treating ASD.
Detailed description
Autism spectrum disorder (ASD) is a complex neurodevelopmental condition characterized by difficulties in social communication, repetitive behaviors, and sensory sensitivities, typically appearing early in life. The disorder's prevalence varies globally, with recent estimates in the US showing approximately 1.7% of children affected. Diagnosis relies on comprehensive evaluations using standardized tools, such as the Autism Diagnostic Observation Schedule, to assess behavioral patterns and developmental history. Individuals with ASD often experience cooccurring conditions like ADHD, anxiety, and epilepsy, which can further impact daily functioning. Motor abnormalities, including toe-walking, are observed in some cases and may indicate underlying neurological issues or developmental delays. Early intervention, including sensory-based therapies and physical exercises like treadmill training, aims to improve motor skills and overall functioning in children with ASD, highlighting the importance of multidisciplinary support for optimal developmental outcomes.
The study will be a Randomized Controlled Trial (RCT) designed to investigate the impact of treadmill interventions on children with autism spectrum disorder (ASD) who exhibit toe-walking behaviors. Legal guardians will receive comprehensive information about the research objectives, methods, and potential benefits, and informed consent will be obtained prior to participation. Initial assessments will thoroughly evaluate each participant's baseline strength, frequency of toe walking, and balance using standardized tools like the 50-foot walk test for toe walking and the Pediatric Balance Scale for balance assessment. Participants meeting specific inclusion criteria: children diagnosed with ASD, displaying toe walking more than 30% of the time, and compliant with the treatment protocol and Exclusion Criteria: Associated orthopedic conditions, underlying genetic disorders, global developmental delay, patient's parents'/guardians' refusal to provide informed consent will be assigned to either Group A or Group B by Non- Probability Convenient Sampling technique. Group A will undergo treadmill sessions while wearing compression stockings for one hour before and during a 10-minute treadmill walk, with incline adjustments from 10% to 12% over six weeks. Group B will undergo identical treadmill sessions without compression stockings. The study will be conducted in a controlled environment at a single autism center, ensuring consistent conditions for both groups. IBM SPSS Statistics version 27 will be used for data analysis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A intervention: Compressions Stocking Group | Experimental | Other: Compressions Stocking Group, Other: Treadmill Training Group* Duration: * Stockings for 1 hour before and during treadmill walking. * Treadmill for 10 minutes. * Frequency: 5 sessions/ week for 6 weeks. |
| Group B intervention: Treadmill Training Group | Active comparator | Other: Compressions Stocking Group, Other: Treadmill Training GroupDuration: Treadmill for 10 minutes. • Frequency: 5 sessions/ week for 6 weeks. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children with ASD who toe walk.
- Gait disorder more than 30% of the time.
- Compliance with our treatment protocol.
- Children whose guardians agreed on the study
Key exclusion criteria (4 listed)
- Associated orthopedic conditions.
- Underlying genetic disorders.
- Global developmental delay.
- Patient's parents'/guardians' refusal to provide informed consent
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 |
|---|---|---|
| Compressions Stocking Group* Incline: Initially 5% incline and after 4 weeks an incline of 10% will be observed * Speed: Constant speed of 3.4 mph. * Warm up: Calf stretch 10 reps/ 2 sets. | Other | Group A intervention: Compressions Stocking Group, Group B intervention: Treadmill Training Group |
| Treadmill Training Group* Incline: Initially 5% incline and after 4 weeks an incline of 10% will be observed * Speed: Constant speed of 3.4 mph. * Warm up: Calf stretch 10 reps/ 2 sets. | Other | Group A intervention: Compressions Stocking Group, Group B intervention: Treadmill Training Group |
Primary outcome
Pediatric Balance Scale
Time frame: baseline, 3rd week, 6th week.
The 14-item Pediatric Balance Scale (PBS) is a tool used to assess children's functional balance. The PBS was created by altering the Berg Balance Scale (BBS) to be used with children with cerebral palsy (CP) who have trouble responding to external stimuli and maintaining their posture. For kids with mild to severe motor impairments, the PBS has been further refined as a balancing assessment tool.
Toe Walking
Time frame: baseline, 3rd week, 6th week.
Trials frequently use the 50-Foot Timed Walk (50FTW) as a gait assessment tool. Initially, exercise-based research was the main application of the 50FWT. Around 15.24 meters (50 feet) away, the participants walk a straight line at their typical walking pace. A fat, colored tape was used to measure a distance of 15.24 meters to chart the course.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Background: PubMed 36890589Dehghani M, Jafarnezhadgero AA, Darvishani MA, Aali S, Granacher U. Effects of an 8-week multimodal exercise program on ground reaction forces and plantar pressure during walking in boys with autism spectrum disorder. Trials. 2023 Mar 8;24(1):170. doi: 10.1186/s13063-023-07158-7.
- Background: PubMed 38162972Grandits JB, Kent HW, Sanborn SM, Pilcher JJ. The effect of compression on repetitive behaviors and task participation in children with autism spectrum disorder. Front Psychol. 2023 Dec 13;14:1292439. doi: 10.3389/fpsyg.2023.1292439. eCollection 2023.
- Individual participant dataSharing planned: No
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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.
Qutbia Abaq Javed Cheema, MS-PPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compressions Stocking Group and Treadmill Training Group in people with Autism Spectrum Disorder, run by Riphah International University at 1 site in Pakistan.
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 25 Mar 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact IMRAN AMJAD, PHD (9233224390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Balance Scale (time frame: baseline, 3rd week, 6th week.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06893718, which also lists 2 linked publications.
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 25 Mar 2025.