Down SyndromeNCT06461858
Effects of Cuevas Medek Exercises on Trunk Control and Balance in Children With Down Syndrome
A study testing cuevas medek technique (exercise) and conventional therapy in people with Down Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 6 years, women only
- Conditions the study is for
- Down Syndrome
- What is being tested?
- cuevas medek technique (exercise) and conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Aug 2024to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- All children with Ds between 2-6 years old children were eligible for inclusion (5).
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 200,000 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 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
- Being tested
- cuevas medek technique (exercise), conventional therapy
- Keywords
- Down syndrome, ,Trunk Control, Balance, conventional therapy., Cuevas Medek exercises
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
conventional therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Baseline and 6th Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start10 Aug 2024
- Primary completion15 Sep 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fareeha Kausar, PP-DPT, Study chair, Riphah International UniversityHafiza Sara wafa, MS-PPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461858
- Sponsor's protocol ID
- REC/RCR & 23/0773
- Status last verified
- Mar 2025
- First submitted
- 12 Jun 2024
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37238393Verheyden 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.
PubMed 15137564de 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.
PubMed 32695363Westcott 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.
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.
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.
PubMed 21068635Mitroi 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cuevas Medek Exercises on Trunk Control and Balance in Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT06461858
- Acronym / sponsor ID
- REC/RCR & 23/0773
- Conditions
- Down Syndrome
- Keywords
- Down syndrome, ,Trunk Control, Balance, conventional therapy., Cuevas Medek exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Aug 2024 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 200,000 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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| This group (Group A) will receive cuevas medek technique (exercise) | Experimental | Other: cuevas medek technique (exercise)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 B) will receive conventional therapy. | Active comparator | Other: conventional therapythis 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. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- All children with Ds between 2-6 years old children were eligible for inclusion (5).
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cuevas medek technique (exercise)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 | This group (Group A) will receive cuevas medek technique (exercise) |
| conventional therapyGroup 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 | This group (Group B) will receive conventional therapy. |
Primary outcome
Trunk Impairment Scale for Trunk Control
Time frame: Baseline and 6th Week
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).
Pediatric Clinical Test of Sensory Interaction for Balance for balance
Time frame: Baseline and 6th Week
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Background: PubMed 37238393Jacewicz 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.
- Background: PubMed 15137564Verheyden 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.
- Background: PubMed 32695363de 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.
- BackgroundWestcott 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.
- BackgroundCrowe 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: PubMed 21068635Franjoine 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.
- BackgroundMitroi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fareeha Kausar, PP-DPT study chair
Riphah International University
Hafiza Sara wafa, MS-PPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cuevas medek technique (exercise) and conventional therapy in people with Down Syndrome, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trunk Impairment Scale for Trunk Control (time frame: Baseline and 6th Week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06461858, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.