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Completed

NCT Number: NCT06673810

Effects of Ankle Weighted Cuffs Training in Autism Children

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.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

4 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pakistan Society for the Rehabilitation of Disabled

Lahore, Punjab Province, 54700, Pakistan

About this study

The current study will be randomized control trial and data will be collected from (PSRD) pakistan society rehablitation of the disabled. The study will include 44 patients equally divided into two groups and randomly allocated. Inclusion criteria for the study will be a parent-confirmed ASD diagnosis from a psychiatrist or licensed psychologist, both male and female children, age between 4 to 14 years. Children with a history of lower limb surgery, a recent (<1 year) ankle sprain and severe behavioral disturbances will be excluded from the study. Experimental group will have ankle weighted cuffs while performing routine physical therapy exercises. Control group will perform routine physical therapy exercises. Outcomes will be analyzed by Limb Position Sense Test and 50 ft walk test. Data collection will be done before and after the intervention. Data will be analyzed through SPSS version 25.00.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Ankle Weighted Cuffs Training Along with Routine Physical Therapy Exercises

Other

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

Routine Physical Therapy Exercises

Other

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

Primary outcomes

  1. Limb Position Sense Test

    Time frame: 6 weeks

    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

    • Hip abduction with full knee extension
    • Hip adduction in neutral
    • Hip flexion with knee flexion with foot on the mat
    • 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

  2. 50 ft Walk Test

    Time frame: 6 weeks

    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

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects Of Ankle Weighted Cuffs Training on Kinesthetic Awareness and Toe Walking in Children With Autism Spectrum Disorder.

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Nov 5, 2024
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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