NCT06673732

Brief Summary

In Autism spectrum disorder (ASD) is a developmental disability caused by differences in the brain. People with ASD often have problems with social communication and interaction, and restricted or repetitive behaviors or interests. People with ASD may also have different ways of learning, moving, or paying attention. The Aim of this thesis is Effects of Muscle Energy Technique with and without Stationary Cycling on toe walking children with Autism Spectrum Disorder This study seeks to explore whether the synergistic application of these interventions can provide a more comprehensive and effective approach in managing the debilitating symptoms associated with toe walking in Autistic children.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2024

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 26, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 3, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 5, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2025

Completed
Last Updated

November 5, 2024

Status Verified

November 1, 2024

Enrollment Period

3 months

First QC Date

November 3, 2024

Last Update Submit

November 3, 2024

Conditions

Keywords

Autism spectrum disorderMuscle Energy TechniqueToe-walkingStationary Cycling

Outcome Measures

Primary Outcomes (1)

  • Observational Gait Scale

    Observational Gait Scale An Assessment/observational gait exam is the Observational Gait Scale (OGS). The OGS is primarily used to rate gait metrics using a structured scale from video recordings It focuses on the knee joint and foot position during mid-stance. . In routine clinical practice, observational gait evaluation is regarded as a more economical option to IGA. The purpose of this paper is to evaluate the validity and reliability of the various pediatric gait analysis techniques by doing a thorough evaluation and comparing them to IGA.(20) The OGS score\'s validity was assessed by contrasting it with the 3-DGA. For knee and foot posture in mid-stance, first foot contact, and heel rise, the OGS was shown to have satisfactory interrater and intrarater reliability with weighted kappas (wk) ranging from 0.53 to 0.91 (intrarater) and 0.43 to 0.86 (interrater).

    8 weeks

Secondary Outcomes (2)

  • foot Posture Index

    5-10 minutes

  • Foot Dynamometer:

    8 weeks

Study Arms (2)

Group A

EXPERIMENTAL

Group A (n=14) will receive Muscle Energy Technique (MET) combined with stationary Cycling. In the first three days, an initial assessment will be conducted, including Visual Gait Analysis, the Observational Gait Scale, and the Foot Posture Index. From Week 1 to 4, MET will involve the patient contracting for 5-10 seconds while the therapist resists, followed by a rapid 10-second stretch (3-5 repetitions), along with stationary Cycling for 5-10 minutes. A follow-up assessment will occur in Week 4. From Week 5 to 8, the same protocol will continue with 5-8 repetitions and cycling for 10-20 minutes, concluding with a final assessment in Week 8.

Other: Muscle Energy Technique without Stationary Cycling

Group B

EXPERIMENTAL

Group B (n=14) will undergo Muscle Energy Technique without stationary cycling. In the first 3 days, an initial assessment, including Visual Gait Analysis, Observational Gait Scale, and Foot Posture Index, will be conducted. From Week 1 to 4, the technique involves the patient contracting for 5-10 seconds while the therapist resists, followed by a rapid 10-second stretch (3-5 repetitions). A follow-up assessment will occur in Week 4. From Week 5 to 8, the same process continues with 5-8 repetitions, ending with a final assessment in Week 8.

Other: Muscle Energy Technique with Stationary Bi-Cyclying

Interventions

MET for post-isometric relaxation of the Achilles, calf, quads, hamstrings, and ankle, position each muscle at resistance, just short of pain. The patient contracts (10-20% effort) for 5-10 seconds while the therapist resists. After relaxing and exhaling, the therapist gently stretches the muscle to the new barrier. Repeat this process 2-3 times, gradually increasing the stretch with each repetition. For PFS MET of the Achilles tendon, calf, quads, hamstrings, and ankle, contract the muscle maximally for 5-10 seconds while the therapist resists. Afterward, the muscle is relaxed, and the therapist quickly stretches it to the new barrier, holding for 10 seconds. Following a 20-second rest, repeat the process 3-5 times. For Reciprocal Inhibition MET, the muscle is placed mid-range, the patient pushes against resistance, then relaxes while the therapist stretches the muscle. This is repeated 3-5 times. Stationary cycling complements the routine.

Group B

MET for post-isometric relaxation of the Achilles, calf, quads, hamstrings, and ankle, position each muscle at resistance, just short of pain. The patient contracts (10-20% effort) for 5-10 seconds while the therapist resists. After relaxing and exhaling, the therapist gently stretches the muscle to the new barrier. Repeat this process 2-3 times, gradually increasing the stretch with each repetition. Post FS MET of the Achilles tendon, calf, quads, hamstrings, and ankle, contract the muscle maximally for 5-10 seconds while the therapist resists. Afterward, the muscle is relaxed, and the therapist quickly stretches it to the new barrier, holding for 10 seconds. Following a 20-second rest, repeat the process 3-5 times. For Reciprocal Inhibition MET, the muscle is placed mid-range, the patient pushes against resistance, then relaxes while the therapist stretches the muscle. This is repeated 3-5 times without Stationary Cycling

Group A

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children with diagnosed Autism .
  • Aged between 4 to 10 years.
  • Autistic children with Toe-Walking
  • Regular for follow-up
  • Both Gender included

You may not qualify if:

  • Children with Comorbidities .
  • Children with mild cognitive dysfunction
  • Children less then 4 year or older than 10 years..
  • Autistic Children with limb deformity
  • Autistic Children with Mental Retardation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54700, Pakistan

RECRUITING

Related Publications (1)

  • Lord C, Brugha TS, Charman T, Cusack J, Dumas G, Frazier T, Jones EJH, Jones RM, Pickles A, State MW, Taylor JL, Veenstra-VanderWeele J. Autism spectrum disorder. Nat Rev Dis Primers. 2020 Jan 16;6(1):5. doi: 10.1038/s41572-019-0138-4.

    PMID: 31949163BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Rna Mohammad Iqbal, MS*

    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
Masking Details
Single( Participant) Participants will get separate treatment protocols and possible efforts will be put to mask the both group about the treatment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2024

First Posted

November 5, 2024

Study Start

September 26, 2024

Primary Completion

January 7, 2025

Study Completion

January 7, 2025

Last Updated

November 5, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations