Autism Spectrum DisorderNCT06198166
Effects of Cuevas Medek Exercises Children With Autism Spectrum Disorder
A study testing Cuevas Medek and Standard kinetic programs in people with Autism Spectrum Disorder, run by Riphah International University at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Cuevas Medek and Standard kinetic programs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2023to 1 Mar 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
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Children with planned surgical or medical surgeries during study period.
- Severe behavioral problems.
- Unstable medical condition.
- History neurological disorder (seizures, epilepsy)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Lahore, Punjab Province, 54000
About this study
Official title: 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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Cuevas Medek, Standard kinetic programs
- Keywords
- Autism Spectrum Disorder, Balance, Cuevas Medek Exercises(CME)
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cuevas MedekOther
Also called Standard
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
Standard kinetic programsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cuevas Medek | Experimental | 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 Receives: Other: Cuevas Medek |
| Standard kinetic programs | Active comparator | 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. Receives: Other: Standard kinetic programs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start1 Dec 2023
- Primary completion1 Feb 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Intsam Aslam, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198166
- Sponsor's protocol ID
- REC/RCR&AHS/23/0752
- Status last verified
- Jun 2024
- First submitted
- 26 Dec 2023
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26171247
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cuevas Medek Exercises on Balance and Posture Control in Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT06198166
- Acronym / sponsor ID
- REC/RCR&AHS/23/0752
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, Balance, Cuevas Medek Exercises(CME)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 10 Jan 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.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Cuevas Medek | Experimental | Other: Cuevas MedekThis 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 |
| Standard kinetic programs | Active comparator | Other: Standard kinetic programsThis 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. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Children with planned surgical or medical surgeries during study period.
- Severe behavioral problems.
- Unstable medical condition.
- History neurological disorder (seizures, epilepsy)
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 MedekAlso: StandardGroup 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 | Cuevas Medek |
| Standard kinetic programsGroup 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. | Other | Standard kinetic programs |
Primary outcome
Pediatric Balance Scale
Time frame: 12 weeks
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.
Posture and posture ability scale
Time frame: 12 weeks
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
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 13 Jun 2024.
- Background: PubMed 26171247Memari 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.
- 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.
Intsam Aslam, MS* 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 and Standard kinetic programs in people with Autism Spectrum Disorder, 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 5 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 13 Jun 2024. 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?
Pediatric Balance Scale (time frame: 12 weeks). 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 NCT06198166, which also lists 1 linked publication.
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 13 Jun 2024.