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Completed

NCT Number: NCT06198166

Effects of Cuevas Medek Exercises Children With Autism Spectrum Disorder

Autism spectrum disorders (ASDs) describe a group of neurodevelopmental conditions in which the individuals face challenges with social engagement. This childhood disorder is characterized by core impairments in social/communication and repetitive behaviors. Autism spectrum disorder (ASD) is a lifelong disorder that occurs in approximately 1 in 68 children aged 8 years. It is primarily characterized by limited social interaction and communication, restricted interest, and stereotyped or repetitive behaviors. The motor deficits associated with ASD can relate to impairments of motor planning and control processes.

This Randomized Clinical Trial will recruit the participants through non probability convenience sampling. Participants will be randomly divided into 2 groups. Two groups of children aged between 2 and 6 years, suffering from autism spectrum disorder, one for control and one for experiment. Controlled will get conventional treatment while study group will get conventional treatment with Cuevas Medak Exercises (CME). Treatment duration is of 12 weeks. Progress will be monitored every month. The frequency of recovery sessions will 3 sessions/week, and the duration of a session will 45 minutes. Patient evaluation will be made at the beginning and the end of the treatment through pediatric balance scale and posture and postural ability scale. Data will be analyzed through SPSS 25.

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Key information

Conditions

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

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

About this study

Autism spectrum disorders (ASDs) describe a group of neurodevelopmental conditions in which the individuals face challenges with social engagement. This childhood disorder is characterized by core impairments in social/communication and repetitive behaviours. Two groups of children aged between 2 and 6 years, suffering from autism spectrum disorder, one for control and one for experiment. Controlled will get conventional treatment while study group will get conventional treatment with Cuevas Medak Exercises (CME). Treatment duration is of 12 weeks. Progress will be monitored every month. The frequency of recovery sessions will 3 sessions/week, and the duration of a session will 45 minutes. Patient evaluation will be made at the beginning and the end of the treatment through pediatric balance scale and posture and postural ability scale. Data will be analyzed through SPSS 25.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children with medical diagnosis of mild ASD diagnosed by CARS assessment tool with score ranges from 15 to 30.
  • Children having postural and balance problems with scoring of 8 out of 14 items of pediatric balance scale.
  • Age ranging from 2 to 6 years
  • Parental/Caregiver report of Difficulty with motor planning, motor skills and/or postural control.
  • Children who will able to follow verbal instruction and participate in exercise program.

Exclusion criteria

  • Children with planned surgical or medical surgeries during study period.
  • Severe behavioral problems.
  • Unstable medical condition.
  • History neurological disorder (seizures, epilepsy)

Treatment and study plan

Cuevas Medek

Other

Group A: will receive Cuevas Medek (CME) In a following procedure: supporting the patient in balance at the leg level and with slight posterior support. Then, once kept in the air for few seconds, slight up and down oscillations will make. The materials that will be used consists of three wooden boxes with the same dimensions (20cm x 40cm x 60cm), a bigger box, a wooden plate and two planks with the same dimensions (17cm x 80cm). Boxes

Other names: Standard

Standard kinetic programs

Other

Group B: will receive standard kinetic programs consisting of stretching (2 sets 15 repetitions with 5 seconds hold) , passive mobilizations (2 sets of 20 repetitions), orthosis( for 6 hours). These techniques and orthotics devices typically focus on tight muscles, maintain proper foot alignment and to address sensory processing difficulties and promote relaxation. Stretching will focus on the hamstrings and calf muscles tightness.

Primary outcomes

  1. Pediatric Balance Scale

    Time frame: 12 weeks

    This tool is used for assessing change from baseline. The PBS is easy to administer, does not require specialized equipment, and can be completed in <20 minutes. A 0 to 4 grading scale provides a quantitative and qualitative measure of performance. It involves 14 mobility tasks, with the tasks varying in degrees of difficulty. The tasks are divided in to 3 domains, sitting balance, standing balance and dynamic balance. The PBS has high validity and reliability of 0.98. 41-56=low fall risk, 21-40 = medium fall risk, 0-20 high fall risk.

  2. Posture and posture ability scale

    Time frame: 12 weeks

    The Posture and Postural Ability Scale is a 7-point ordinal scale for the assessment of postural ability in standing, sitting, supine and prone. There are six items for assessment of quality of posture in the frontal plane and another six items in the sagittal plane. The Cronbach alpha value of posture and postural ability scale is 0.98

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Cuevas Medek Exercises on Balance and Posture Control in Children With Autism Spectrum Disorder

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 10, 2024
Registry last updated
Jun 13, 2024

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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