Effects of Cuevas Medek Exercises Children With Autism Spectrum Disorder

Effects of Cuevas Medek Exercises on Balance and Posture Control in 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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Other: Cuevas Medek; Other: Standard kinetic programs

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • Riphah International University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cuevas Medek; This group will receive 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. These oscillations will reflexively induce an increase in tone of the body extensors, but also of the lower limbs. Always from the same position, gait movements will be imitated. At the beginning, due to poor coordination between muscle groups, the child may tend to go outside the support base and therefore we have to "run" following his center of gravity. The action is similar to the one when someone try to maintain balance of a cane in the palm and have to move his hands according to the cane's oscillation until he manage to regain balance	Other: Cuevas Medek; 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
Active Comparator: Standard kinetic programs; This group 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.	Other: Standard kinetic programs; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pediatric Balance Scale	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.	12 weeks
Posture and posture ability scale	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	12 weeks

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Intsam Aslam, MS*, Riphah International University

Publications and helpful links

General Publications

• Memari AH, Panahi N, Ranjbar E, Moshayedi P, Shafiei M, Kordi R, Ziaee V. Children with Autism Spectrum Disorder and Patterns of Participation in Daily Physical and Play Activities. Neurol Res Int. 2015;2015:531906. doi: 10.1155/2015/531906. Epub 2015 Jun 15.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): March 1, 2024

Study Registration Dates

• First Submitted: December 26, 2023
• First Submitted That Met QC Criteria: December 26, 2023
• First Posted (Actual): January 10, 2024

Study Record Updates

• Last Update Posted (Actual): June 13, 2024
• Last Update Submitted That Met QC Criteria: June 11, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Balance; Autism Spectrum Disorder; Cuevas Medek Exercises(CME)
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
• Other Study ID Numbers: REC/RCR&AHS/23/0752

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No