Effects of Ankle Weighted Cuffs Training in Autism Children

NCT ID: NCT06673810

Last Updated: 2025-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-28

Study Completion Date

2025-01-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group A

Ankle Weighted Cuffs Training Along with Routine Physical Therapy Exercises

Group Type EXPERIMENTAL

Ankle Weighted Cuffs Training Along with Routine Physical Therapy Exercises

Intervention Type 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

Control Group

Routine Physical Therapy Exercises

Group Type OTHER

Routine Physical Therapy Exercises

Intervention Type 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

Interventions

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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

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hafiza Rashida Maqbool, MS*

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Pakistan Society for the Rehabilitation of Disabled

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type BACKGROUND
PMID: 31489038 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34340633 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32668622 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38108559 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31678694 (View on PubMed)

Other Identifiers

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REC/RCR/AHS/24/0705

Identifier Type: -

Identifier Source: org_study_id

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