AzTrials
AzTrials

Autism Spectrum DisorderNCT06673810

Effects of Ankle Weighted Cuffs Training in Autism Children

A study testing Ankle Weighted Cuffs Training Along with Routine Physical Therapy Exercises and Routine Physical Therapy Exercises in people with Autism Spectrum Disorder, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 4 to 14 years
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
Ankle Weighted Cuffs Training Along with Routine Physical Therapy Exercises and Routine Physical Therapy Exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 sitePakistan
Study dates
28 Oct 2024to 15 Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Pakistan Society for the Rehabilitation of Disabled

    Lahore, Punjab Province, 54700

Other trials in Pakistan

About this study

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

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.

Read the detailed description

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.

Being tested
Ankle Weighted Cuffs Training Along with Routine Physical Therapy Exercises, Routine Physical Therapy Exercises
Keywords
Kinesthetic awareness, Toe walking, Ankle weighted training, Autism Spectrum Disorder
Medical subject headings
Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ankle Weighted Cuffs Training Along with Routine Physical Therapy ExercisesOther

    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 ExercisesOther

    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

Study groups in NCT06673810
Study groupRoleWhat they receive
Group AExperimentalAnkle Weighted Cuffs Training Along with Routine Physical Therapy Exercises
Receives: Other: Ankle Weighted Cuffs Training Along with Routine Physical Therapy Exercises
Control GroupOtherRoutine Physical Therapy Exercises
Receives: Other: Routine Physical Therapy Exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6 weeks

  2. 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

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2024
  2. Study start28 Oct 2024
  3. Primary completion25 Dec 2024
  4. Study completion15 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06673810
Sponsor's protocol ID
REC/RCR/AHS/24/0705
Status last verified
Jan 2025
First submitted
3 Nov 2024
Last updated
23 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31489038

  • 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.

    PubMed 34340633

  • 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.

    PubMed 32668622

  • 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.

    PubMed 38108559

  • 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.

    PubMed 31678694

Questions about this trial

What is this clinical trial studying?

A study testing Ankle Weighted Cuffs Training Along with Routine Physical Therapy Exercises and Routine Physical Therapy Exercises in people with Autism Spectrum Disorder, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Limb Position Sense Test (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06673810, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in