NCT06673810

Brief Summary

Autism spectrum disorders (ASD) are a diverse group of conditions. They are characterized by some degree of difficulty with social interaction, communication and behaviors. Kinesthetic awareness can be defined as how we sense our body and the way it moves. This person might have difficulty understanding where their body is in relation to other objects, thus appearing clumsy, knocking things over, dropping items or misjudging personal space and thus standing too close to others.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

October 28, 2024

Completed
6 days 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

December 25, 2024

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
Last Updated

January 23, 2025

Status Verified

January 1, 2025

Enrollment Period

2 months

First QC Date

November 3, 2024

Last Update Submit

January 22, 2025

Conditions

Keywords

Kinesthetic awarenessToe walkingAnkle weighted trainingAutism Spectrum Disorder

Outcome Measures

Primary Outcomes (2)

  • Limb Position Sense Test

    For the limb-matching test, Participant instructed to keep his eyes closed while the therapist positioned one extremity, and he then was instructed to copy the position with his opposite extremity. Then participant will be asked to replicate 4 positions with his lower extremities while positioned supine on a mat. The limb-matching test positions are described. Limb Matching Test Positions 1. Hip abduction with full knee extension 2. Hip adduction in neutral 3. Hip flexion with knee flexion with foot on the mat 4. Hip and knee flexion at 90° Dynamic Position Sense Movements for Limb Movement Sense Test 1.Hip circles counterclockwise 2.Hip circles clockwise 3.Active hip abduction and adduction with knee fully extended Intra-class correlations (ICC), which are most often used to express test-retest reliability, were moderate at best, ranging from 0·40 to 0·61 for the four types of position sense tests

    6 weeks

  • 50 ft Walk Test

    The aim of the 50-FWT is to determine the percentage of toe walking performed by each child over a 50ft distance. During the 50-FWT, the children are barefoot to ensure the physical therapist's view of their feet is not obstructed by shoes. To prevent the child from walking past the 50-ft distance, a parent or therapist stands at the end of the walk test to assist in stopping. This allows the physical therapist to read the pedometer value before the child began to move again. The child stands at the start line and the accelerometer is set to 0. Each child ambulates 50 ft. The physical therapist walks at least 6 ft behind the child to assess toe walking while not interfering with gait. The pedometer counts the total number of steps taken during the 50-FWT. The therapist counts the number of steps with initial contact on the toe. The number of toe-walking steps counted by the therapist is divided by the total number of steps counted by the pedometer to get a percentage of toe walking

    6 weeks

Study Arms (2)

Group A

EXPERIMENTAL

Ankle Weighted Cuffs Training Along with Routine Physical Therapy Exercises

Other: Ankle Weighted Cuffs Training Along with Routine Physical Therapy Exercises

Control Group

OTHER

Routine Physical Therapy Exercises

Other: Routine Physical Therapy Exercises

Interventions

Group A will have free ankle weighted cuffs while performing routine physical therapy. These weighted cuffs will be above of the child's ankle and child will be encouraged to perform his/her routine physical activities. Ankle weights will correspond to 2% to 3% of the individual's body weight (sandbags) will be attached at 5 cm above the left and right ankle joints

Group A

Group B will perform all the routine physical exercises which include jogging, walk/run interval training, treadmill training and cycling . Intervention period will be of 6 weeks comprising of 3 sessions per week of 30 to 45 minutes per session

Control Group

Eligibility Criteria

Age4 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • A pre-diagnosed autism spectrum disorder from a psychiatrist or licensed psychologist.
  • Both male and female children.
  • Age between 4 to 14 years.

You may not qualify if:

  • Children with a history of lower limb surgery.
  • Children with a recent (\<1 year) ankle sprain.
  • Children presented severe behavioral disturbances, such as aggressive behaviors, self- injurious behaviors, severe motor hyperactivity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan Society for the Rehabilitation of Disabled

Lahore, Punjab Province, 54700, Pakistan

Location

Related Publications (5)

  • Leyden J, Fung L, Frick S. Autism and toe-walking: are they related? Trends and treatment patterns between 2005 and 2016. J Child Orthop. 2019 Aug 1;13(4):340-345. doi: 10.1302/1863-2548.13.180160.

    PMID: 31489038BACKGROUND
  • Armitano-Lago C, Bennett HJ, Haegele JA. Lower Limb Proprioception and Strength Differences Between Adolescents With Autism Spectrum Disorder and Neurotypical Controls. Percept Mot Skills. 2021 Oct;128(5):2132-2147. doi: 10.1177/00315125211036418. Epub 2021 Aug 2.

    PMID: 34340633BACKGROUND
  • Guinchat V, Vlamynck E, Diaz L, Chambon C, Pouzenc J, Cravero C, Baeza-Velasco C, Hamonet C, Xavier J, Cohen D. Compressive Garments in Individuals with Autism and Severe Proprioceptive Dysfunction: A Retrospective Exploratory Case Series. Children (Basel). 2020 Jul 13;7(7):77. doi: 10.3390/children7070077.

    PMID: 32668622BACKGROUND
  • Valagussa G, Purpura G, Balatti V, Trentin L, Signori A, Grossi E. Quantitative assessment of tip-toe behavior in individuals with autism spectrum disorder and intellectual disability: A cross-sectional study. Autism Res. 2024 Feb;17(2):311-323. doi: 10.1002/aur.3072. Epub 2023 Dec 18.

    PMID: 38108559BACKGROUND
  • Washabaugh EP, Augenstein TE, Krishnan C. Functional resistance training during walking: Mode of application differentially affects gait biomechanics and muscle activation patterns. Gait Posture. 2020 Jan;75:129-136. doi: 10.1016/j.gaitpost.2019.10.024. Epub 2019 Oct 21.

    PMID: 31678694BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Hafiza Rashida Maqbool, MS*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2024

First Posted

November 5, 2024

Study Start

October 28, 2024

Primary Completion

December 25, 2024

Study Completion

January 15, 2025

Last Updated

January 23, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations