Effects of Cuevas Medek Exercises on Trunk Control and Balance in Children With Down Syndrome

NCT06461858 | Completed

• 1 other identifier: REC/RCR & 23/0773
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Down syndrome, a genetic condition caused by the presence of an extra copy of chromosome 21. This additional genetic material affects the normal development of the brain and body, leading to intellectual and developmental delays. Individuals with Down syndrome often have distinctive physical features, such as a flat facial profile, almond-shaped eyes, and a short neck. Down syndrome has three types include Trisomy 21 (95% cases, extra chromosome 21), Translocation (3-4%, extra part attached), and Mosaic (1-2%, mixture of normal and trisomic cells). Children with Down syndrome often face challenges in motor development, including issues with muscle tone and coordination. However, targeted interventions and exercises, such as those focused on trunk control and balance, can have positive impact. The significance of this study is that it will define that specific exercises will affect the trunk control and balance in children with down syndrome. This will be a randomized clinical trial; data will be collected from Rising Sun Institute in Lahore. Study will be conducted on 32 patients. The study will include children with Down syndrome aged between 2- and 6-years old children. Patients have uncontrolled epilepsy, Surgical or other medical intervention not included in study. In our data collection, there are two distinct groups, having same baseline of trunk control and balance. The first group, known as the experimental group, group A, receives Cuevas Medek exercises three times a week, twice a day, for 45 minutes per session, in contrast, group B, referred to as the conventional therapy group (Routine physical therapy), follows a regimen of conventional therapy 2 times a week for 6 weeks for 20 mints. Variables will be measured by following measurement tools:1. Trunk control measured through TIS (trunk impairment scale) assesses Static Sitting Balance, Dynamic Sitting Balance, and Coordination. 2. Pediatric Clinical Test of Sensory Interaction for Balance (P-CTSIB) used to identify the balance impairments in pediatric populations. 3.Balance appraised with the Berg Balance Scale (PBS). Pre and post assessment of trunk control and balance perform by these tools.

Conditions

Down Syndrome

Keywords

Down syndrome; ,Trunk Control; Balance; conventional therapy.; Cuevas Medek exercises

Outcome Measures

Primary Outcomes (2)

• Trunk Impairment Scale for Trunk Control

  This scale assesses the control in trunk muscles. The static subscale investigates: (1) the ability of the subject to maintain a sitting position with feet supported; (2) the ability to maintain a sitting position while the legs are passively crossed, and (3) the ability to maintain a sitting position when the subject crosses the legs actively. Interpretation: For each item, a 2-, 3- or 4-point ordinal scale is used. On the static and dynamic sitting balance and coordination subscales the maximal scores that can be attained are 7, 10 and 6 points. The total score for TIS ranges between 0 for a minimal performance to 23 for a perfect performance. Reliability: Intra-observer and inter-observer reliability is high. Test/retest and interobserver reliability for the TIS total score (ICC) - 0.96 and 0.99, respectively. Validity:(construct validity) was 0.86, between the TIS and the Trunk Control Test (concurrent validity) 0.83 (6).

  Baseline and 6th Week

• Pediatric Clinical Test of Sensory Interaction for Balance for balance

  This scale is used to identify the balance impairments in pediatric populations. Patient completes 3 trials of each of the 6 conditions (with hands on hips): stand on firm surface eyes open, stand on firm surface eyes closed, stand on firm surface with conflict dome, stand on foam eyes open, stand on foam eyes closed, stand on foam with conflict dome. The patient then completes all 6 conditions in narrow base of support with malleoli touching and tandem stance. The best score of 2 trials for each condition is documented (higher time or least sway). Timing is stopped if the child makes a postural adjustment (moving hands, feet, or eyes) (7).Reliability: Interrater=.69-.90; test-retest=.45-.78.Validity: construct validity= .63-.68 (8).

  Baseline and 6th Week

Study Arms (2)

This group (Group A) will receive cuevas medek technique (exercise)

EXPERIMENTAL

The first group, known as the experimental group, group A, receives Cuevas Medek exercises once a week, for 45 minutes per session,for 6 weeks.

Other: cuevas medek technique (exercise)

This group (Group B) will receive conventional therapy.

ACTIVE COMPARATOR

this second group, group B, referred to as the conventional therapy group (Routine physical therapy), follows a regimen of conventional therapy once a week for 6 weeks for 20 mints.

Other: conventional therapy

Interventions

cuevas medek technique (exercise) OTHER

The first group, known as the experimental group, group A, receives Cuevas Medek exercises once a week, for 45 minutes per session,for 6 weeks

This group (Group A) will receive cuevas medek technique (exercise)

conventional therapy OTHER

Group B, referred to as the conventional therapy group (Routine physical therapy), follows a regimen of conventional therapy once a week for 6 weeks for 20 mints.

This group (Group B) will receive conventional therapy.

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Encompass children with scores falling within 41-50 range on the Berg Balance Scale.
• Had not received any strengthening exercise program in past 3 months
• Consent from parents and participants should be taken.

You may not qualify if:

• Epilepsy
• Surgical or other medical intervention scheduled during the intervention period or up to three months prior to the trial
• Participant unable to give clear voluntary assent and/or no written consent given by parent or guardian (5).
• Orthopedic condition or medical problems that prevent children from participating in exercise (4).

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Al-Qaim Hospital

Rawalpindi, Punjab Province, 04625, Pakistan

Location

Related Publications (7)

• Jacewicz J, Dziuba-Slonina A, Chwalczynska A. Assessment of Balance Parameters in Children with Weakened Axial Muscle Tone Undergoing Sensory Integration Therapy. Children (Basel). 2023 May 7;10(5):845. doi: 10.3390/children10050845.

  PMID: 37238393 BACKGROUND

• Verheyden G, Nieuwboer A, Mertin J, Preger R, Kiekens C, De Weerdt W. The Trunk Impairment Scale: a new tool to measure motor impairment of the trunk after stroke. Clin Rehabil. 2004 May;18(3):326-34. doi: 10.1191/0269215504cr733oa.

  PMID: 15137564 BACKGROUND

• de Oliveira GR, Fabris Vidal M. A normal motor development in congenital hydrocephalus after Cuevas Medek Exercises as early intervention: A case report. Clin Case Rep. 2020 Apr 27;8(7):1226-1229. doi: 10.1002/ccr3.2860. eCollection 2020 Jul.

  PMID: 32695363 BACKGROUND

• Westcott SL, Crowe TK, Deitz JC, Richardson PK. Test-retest reliability of the pediatric clinical test of sensory interaction for balance (P-CTSIB). Physical & Occupational Therapy in Pediatrics. 1994;14(1):1-22.

  BACKGROUND

• Crowe TK, Deitz JC, Richardson PK, Atwater SW. Interrater reliability of the pediatric clinical test of sensory interaction for balance. Physical & Occupational Therapy in Pediatrics. 1991;10(4):1-27.

  BACKGROUND

• Franjoine MR, Darr N, Held SL, Kott K, Young BL. The performance of children developing typically on the pediatric balance scale. Pediatr Phys Ther. 2010 Winter;22(4):350-9. doi: 10.1097/PEP.0b013e3181f9d5eb.

  PMID: 21068635 BACKGROUND

• Mitroi S. Stimulation of triple extension tone and orthostatic balance in the child with cerebral palsy through exercises specific to Medek method. Physical Education, Sport and Kinesiology Journal. 2016;1(43):48-51.

  BACKGROUND

MeSH Terms

Conditions

Down Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Fareeha Kausar, PP-DPT

  Riphah International University

  STUDY CHAIR

• Hafiza Sara wafa, MS-PPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 17, 2024
• Study Start: August 10, 2024
• Primary Completion: September 15, 2024
• Study Completion: October 1, 2024
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)