- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06673810
Effects of Ankle Weighted Cuffs Training in Autism Children
Effects Of Ankle Weighted Cuffs Training on Kinesthetic Awareness and Toe Walking in Children With Autism Spectrum Disorder.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54700
- Pakistan Society for the Rehabilitation of Disabled
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A
Ankle Weighted Cuffs Training Along with Routine Physical Therapy Exercises
|
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
|
|
Other: Control Group
Routine Physical Therapy Exercises
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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
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
|
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hafiza Rashida Maqbool, MS*, Riphah International University
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR/AHS/24/0705
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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