Treadmill Training With and Without Compression Stockings on Toe Walking and Balance in Children With Autism.
Effects of Treadmill Training With and Without Compression Stockings on Toe Walking and Balance in Children With Autism.
1 other identifier
interventional
24
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 15, 2025
CompletedFirst Submitted
Initial submission to the registry
March 19, 2025
CompletedFirst Posted
Study publicly available on registry
March 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 12, 2025
CompletedMarch 25, 2025
March 1, 2025
1 month
March 19, 2025
March 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
baseline, 3rd week, 6th week.
Study Arms (2)
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.
Group B intervention: Treadmill Training Group
ACTIVE COMPARATORDuration: Treadmill for 10 minutes. • Frequency: 5 sessions/ week for 6 weeks.
Interventions
* 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.
* 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Associated orthopedic conditions.
- Underlying genetic disorders.
- Global developmental delay.
- Patient's parents'/guardians' refusal to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Muhammad Asif Javed
Lahore, Punjab Province, 54000, Pakistan
Related Publications (2)
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.
PMID: 36890589BACKGROUNDGrandits 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.
PMID: 38162972BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Qutbia Abaq Javed Cheema, MS-PPT
Riphah International University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2025
First Posted
March 25, 2025
Study Start
March 15, 2025
Primary Completion
April 28, 2025
Study Completion
May 12, 2025
Last Updated
March 25, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share