Effects of Cuevas Medek Exercises on Trunk Control and Balance in Children With Down Syndrome
NCT Number: NCT06461858
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Down Syndrome
Interventions: OTHER: cuevas medek technique (exercise)|OTHER: conventional therapy
Sponsor: Riphah International University
Sex: FEMALE
Age: CHILD
Enrollment: 32
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-10
Completion Date: 2024-10-01
Locations: Al-Qaim Hospital, Rawalpindi, Punjab, 04625, Pakistan

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.

Primary Outcome Measures: 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