Ignite Creation Date:
2024-07-17 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06461858
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-06-12
Brief Title:
Effects of Cuevas Medek Exercises on Trunk Control and Balance in Children With Down Syndrome
Sponsor:
Riphah International University
Organization:
Riphah International University
Study Overview
Official Title:
Effects of Cuevas Medek Exercises on Trunk Control and Balance in Children With Down Syndrome
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 tools1 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 3Balance appraised with the Berg Balance Scale PBS Pre and post assessment of trunk control and balance perform by these tools
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 tools1 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 3Balance appraised with the Berg Balance Scale PBS Pre and post assessment of trunk control and balance perform by these tools
Detailed Description:
Cuevas Medek Exercises CME is a pediatric physiotherapy approach for children with developmental motor delay impacting the central nervous system According to Ramon Cuevas the creator of the method its main principle involves provoking novel automatic motor reactions using exercises against gravity with progressive distal holdings The physiotherapy intervention was composed of 1-hour sessions once or twice per week and daily home program exercises In CME interventions the exercises are repeated 3 5 or 8 times depending on the effectiveness and the quality of the expected reaction The better the reaction the more repetitions are done Moreover different and more challenging exercises should be performed to provoke the brain to react in a new way 1
Down syndrome Ds is an autosomal disorder caused by the presence of an extra chromosome 21 also known as trisomy 21 Statistics vary but it is estimated that over 200000 people in the United States today have Ds 2 Ds causes a range of intellectual disabilities and developmental delays in motor skills The lifespan of people with Ds has increased from an average of 12 years in the 1940s to 60 years now for people with Ds in high-income countries Most adults with Ds lead a sedentary lifestyle previous research reported that less than 10 of adults with Ds achieve the recommended amount of physical activity Adults with Ds often experience cardiovascular issues and generally higher rates of obesity than their peers and low aerobic capacity In addition to lower cardiovascular function individuals with Ds exhibit lower strength compared with other sedentary peers In children with Down syndrome dysfunction of stereognosis and decrease in motor skills are also related to hypotonia Hypotonicity disrupts the feedback mechanism which enables the perception of the position of the body in space and plays a role in the voluntary control of muscles and as a result body posture and the quality of movement are affected 3
Children with weakened axial muscle tone face various problems every day One is maintaining a stable body posture which limits their participation in activities and games with peers The study aimed to assess balance parameters in children with weakened axial muscle tone Disturbances in ADL and IADL may be caused among other things by reduced muscle tone Children with weakened muscle tone often have problems with properly integrating stimuli because skeletal muscles whose strength is weakened in these children are involved in mobility strength and balance enabling participation and performance of various activities Previous studies have shown that low muscle mass and strength contribute to adverse health effects in childhood such as increased risk of metabolic dysfunctions cardiovascular diseases reduction of bone minerals or poorer cognitive and motor performance in early childhood compared to other children of the same age These children in the later period struggle not only with motor difficulties but also with cognitive ones There are several neuromuscular and musculoskeletal characteristics in Down syndrome which can result in developmental delays generalized hypotonia and laxity of the joints due to hypotonia are present 1
These factors may cause motor and postural delays sensory processing and sensory integration deficits due to limitations in primary sensory experiments when the sensory and motor interventions are performed earlier it is probably more effective on the improvement of generation of new synapses and prevention of decrease in synapses in the next years of the life of these children and more neuro-plasticity of the nervous system Individuals with Ds often have significant involvement of the musculoskeletal system including ligamentous laxity and low muscle tone leading to a higher risk of pes planus scoliosis hip disorders and patellar instability if untreated Strengthening of core muscles and joint stabilizers are frequently recommended strategies to counteract the effects of ligamentous laxity and low muscle tone 2
This study aims will investigate the impact of Cuevas Medek exercises on trunk control and balance in children with Down syndrome Additionally it seeks to discern any distinctions in outcomes between conventional exercises or strength training alone and a combination of conventional exercises and Cuevas Medek exercises in terms of trunk abdominal lumbar endurance and overall balance in this specific population of children with down syndrome
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 tools1 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 3Balance appraised with the Berg Balance Scale PBS Pre and post assessment of trunk control and balance perform by these tools
Down syndrome Ds is an autosomal disorder caused by the presence of an extra chromosome 21 also known as trisomy 21 Statistics vary but it is estimated that over 200000 people in the United States today have Ds 2 Ds causes a range of intellectual disabilities and developmental delays in motor skills The lifespan of people with Ds has increased from an average of 12 years in the 1940s to 60 years now for people with Ds in high-income countries Most adults with Ds lead a sedentary lifestyle previous research reported that less than 10 of adults with Ds achieve the recommended amount of physical activity Adults with Ds often experience cardiovascular issues and generally higher rates of obesity than their peers and low aerobic capacity In addition to lower cardiovascular function individuals with Ds exhibit lower strength compared with other sedentary peers In children with Down syndrome dysfunction of stereognosis and decrease in motor skills are also related to hypotonia Hypotonicity disrupts the feedback mechanism which enables the perception of the position of the body in space and plays a role in the voluntary control of muscles and as a result body posture and the quality of movement are affected 3
Children with weakened axial muscle tone face various problems every day One is maintaining a stable body posture which limits their participation in activities and games with peers The study aimed to assess balance parameters in children with weakened axial muscle tone Disturbances in ADL and IADL may be caused among other things by reduced muscle tone Children with weakened muscle tone often have problems with properly integrating stimuli because skeletal muscles whose strength is weakened in these children are involved in mobility strength and balance enabling participation and performance of various activities Previous studies have shown that low muscle mass and strength contribute to adverse health effects in childhood such as increased risk of metabolic dysfunctions cardiovascular diseases reduction of bone minerals or poorer cognitive and motor performance in early childhood compared to other children of the same age These children in the later period struggle not only with motor difficulties but also with cognitive ones There are several neuromuscular and musculoskeletal characteristics in Down syndrome which can result in developmental delays generalized hypotonia and laxity of the joints due to hypotonia are present 1
These factors may cause motor and postural delays sensory processing and sensory integration deficits due to limitations in primary sensory experiments when the sensory and motor interventions are performed earlier it is probably more effective on the improvement of generation of new synapses and prevention of decrease in synapses in the next years of the life of these children and more neuro-plasticity of the nervous system Individuals with Ds often have significant involvement of the musculoskeletal system including ligamentous laxity and low muscle tone leading to a higher risk of pes planus scoliosis hip disorders and patellar instability if untreated Strengthening of core muscles and joint stabilizers are frequently recommended strategies to counteract the effects of ligamentous laxity and low muscle tone 2
This study aims will investigate the impact of Cuevas Medek exercises on trunk control and balance in children with Down syndrome Additionally it seeks to discern any distinctions in outcomes between conventional exercises or strength training alone and a combination of conventional exercises and Cuevas Medek exercises in terms of trunk abdominal lumbar endurance and overall balance in this specific population of children with down syndrome
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 tools1 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 3Balance appraised with the Berg Balance Scale PBS Pre and post assessment of trunk control and balance perform by these tools
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None