Treadmill Training With and Without Compression Stockings on Toe Walking and Balance in Children With Autism.

NCT ID: NCT06893718

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-15
• Study Completion Date: 2025-05-12

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Group A intervention: Compressions Stocking Group

• Duration:
• Stockings for 1 hour before and during treadmill walking.
• Treadmill for 10 minutes.
• Frequency: 5 sessions/ week for 6 weeks.

Group Type: EXPERIMENTAL

Compressions Stocking Group

Intervention Type: OTHER

• 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 Group

Intervention Type: OTHER

• 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.

Group B intervention: Treadmill Training Group

Duration: Treadmill for 10 minutes.

• Frequency: 5 sessions/ week for 6 weeks.

Group Type: ACTIVE_COMPARATOR

Compressions Stocking Group

Intervention Type: OTHER

• 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 Group

Intervention Type: OTHER

• 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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Associated orthopedic conditions.
• Underlying genetic disorders.
• Global developmental delay.
• Patient's parents'/guardians' refusal to provide informed consent

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qutbia Abaq Javed Cheema, MS-PPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Muhammad Asif Javed

Lahore, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

IMRAN AMJAD, PHD

Role: CONTACT

imran.amjad@riphah.edu.pk

9233224390125

Muhammad Asif Javed, MS

Role: CONTACT

a.javed@riphah.edu.pk

923224209422

Facility Contacts

Muhammad Asif Javed, MS-PT(Neuro)

Role: primary

a.javed@riphah.edu.pk

923224209422

References

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.

Reference Type: BACKGROUND

PMID: 36890589 (View on PubMed)

Grandits 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.

Reference Type: BACKGROUND

PMID: 38162972 (View on PubMed)

Other Identifiers

REC/RCR/AHS/25/qutbia abaq

Identifier Type: -

Identifier Source: org_study_id