NCT06893718

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

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2025

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2025

Completed
Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

1 month

First QC Date

March 19, 2025

Last Update Submit

March 19, 2025

Conditions

Keywords

"Autism, Toe Walking, Treadmill, Compression Stockings.

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.

Other: Compressions Stocking GroupOther: Treadmill Training Group

Group B intervention: Treadmill Training Group

ACTIVE COMPARATOR

Duration: Treadmill for 10 minutes. • Frequency: 5 sessions/ week for 6 weeks.

Other: Compressions Stocking GroupOther: Treadmill Training Group

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.

Group A intervention: Compressions Stocking GroupGroup B intervention: 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.

Group A intervention: Compressions Stocking GroupGroup B intervention: Treadmill Training Group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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

RECRUITING

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: 36890589BACKGROUND
  • 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.

    PMID: 38162972BACKGROUND

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Qutbia Abaq Javed Cheema, MS-PPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Asif Javed, MS

CONTACT

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

Locations