Spastic Cerebral PalsyNCT05719623
Cuevas Medek Exercises on Balance and Postural Control in Children With Spastic Cerebral Palsy
A study testing CUEVAS MEDEK EXERCISES and BALANCE AND POSTURAL in people with Spastic Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
Cerebral palsy (CP) is a disorder characterized by abnormal tone, posture and movement and clinically classified based on the predominant motor syndrome-spastic hemiplegia, spastic diplegia, spastic quadriplegia, and extra-pyramidal or dyskinetic. Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Spastic Cerebral Palsy
- What is being tested?
- CUEVAS MEDEK EXERCISES and BALANCE AND POSTURAL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 sitePakistan
- Study dates
- 9 Feb 2023to 30 Sep 2023
- 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 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children with medical diagnosis of Spastic Cerebral Palsy
- Age ranging from 2 to 5 years.
- Children who will able to stand and walk
Who cannot join
- Children with planned surgical or medical surgeries during study period
- Children with impaired cognition
- Children with hearing impairment and visual impairment
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Helping Hands Organization (HHRD) Bahawalpur.
Bahawalpur, Punjab Province, 63080.
About this study
Official title: Effects of Cuevas Medek Exercises on Balance and Postural Control in Children With Spastic Cerebral Palsy
Cerebral palsy (CP) is a disorder characterized by abnormal tone, posture and movement and clinically classified based on the predominant motor syndrome-spastic hemiplegia, spastic diplegia, spastic quadriplegia, and extra-pyramidal or dyskinetic. Clinical prediction models and neuroimaging have been used to diagnose CP before the age of 2 years, but further research is necessary. Cuevas Medek Exercises (CME) is a pediatric physiotherapy approach for children with developmental motor delay impacting the central nervous system. According to Ramon Cuevas, who developed the therapy, CME are mainly based on the principle of provoking novel automatic motor reactions using exercises against gravity with progressive distal holding. This study will find the effects of Cuevas Medak Exercises on Balance and Postural control in children with spastic cerebral palsy.
This Randomized Controlled Trial will recruit the participants through random sampling. Participants will be randomly divided into 2 groups. Two groups of children aged between 2 and 5 years, suffering from cerebral palsy in spastic form, one for control and one for experiment. Controlled will get conventional treatment while study group will get conventional treatment with Cuevas Medak Exercises. Treatment duration is of 12 weeks. Progress will 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 static balance test. Data will be analyzed through SPSS 25.
Read the detailed description
Cerebral palsy (CP) is a disorder characterized by abnormal tone, posture and movement and clinically classified based on the predominant motor syndrome-spastic hemiplegia, spastic diplegia, spastic quadriplegia, and extra-pyramidal or dyskinetic (1). Children born preterm account for one-third to one-half of CP diagnoses in HICs, although this proportion is much lower in low-income countries (LICs), where mortality of very preterm babies remains high . Clinical prediction models and neuroimaging have been used to diagnose CP before the age of 2 years, but further research is necessary (.
The CPs share a common clinical sign of non-progressive dysfunction of posture and movement control but not a common diagnosis. Although there are many CP types, many causes, and now many associated pathogenic genetic variants, it is probably not advisable to change the clinical diagnosis of CP made by specialist pediatricians in cases that fulfill the clinical definition.
In order to prevent greater developmental motor delay, a physiotherapy intervention focusing on optimizing neuroplasticity must be done, stimulating the child to achieve the developmental motor milestones . Cuevas Medek Exercises (CME) is a pediatric physiotherapy approach for children with developmental motor delay impacting the central nervous system. According to Ramon Cuevas, who developed the therapy, CME are mainly based on the principle of provoking novel automatic motor reactions using exercises against gravity with progressive distal holding CME therapy is a physiotherapy approach to treat children with developmental motor delay by impacting CNS. Postural control and balance training are essentials for the children to be mobile. The aim of the study is to find the effects of Cuevas Medek Exercises on balance and postural control on children with spastic Cerebral Palsy so that the children with motor development disorders of neurological cause like cerebral palsy can develop automatic motor reactions which they would not be able to develop on their own, because of neurological injuries and help them to improve their quality of life.
- Conditions
- Spastic Cerebral Palsy
- Being tested
- CUEVAS MEDEK EXERCISES, BALANCE AND POSTURAL
- Keywords
- Spastic Cerebral Palsy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CUEVAS MEDEK EXERCISESOther
Also called Conventional Physical therapy
stretchings/strengthening
BALANCE AND POSTURALOther
BALANCE AND POSTURAL
| Study group | Role | What they receive |
|---|---|---|
| CUEVAS MEDEK EXERCISES | Experimental | Experimental group will get conventional treatment along with Cuevas Medak Exercises Receives: Other: CUEVAS MEDEK EXERCISES |
| BALANCE AND POSTURAL | Other | Controlled will get conventional treatment Receives: Other: BALANCE AND POSTURAL |
What is being measured
The primary outcome is the main question the study is designed to answer.
pediatric balance scale
The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points
Measured: 12 weeks
Secondary outcomes (1)
static balance test.
The Four Stage Balance Test is a validated measure recommended to screen individuals for fall risk. It is based on the persons ability to hold four progressively more challenging positions[1](evaluates static balance).
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 posted9 Feb 2023
- Study start9 Feb 2023
- Primary completion31 Aug 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic Cerebral PalsyStudies 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
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara khan, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05719623
- Sponsor's protocol ID
- REC/RCR&AHS/22/0734
- Status last verified
- Oct 2023
- First submitted
- 31 Jan 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cuevas Medek Exercises on Balance and Postural Control in Children With Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05719623
- Acronym / sponsor ID
- REC/RCR&AHS/22/0734
- Conditions
- Spastic Cerebral Palsy
- Keywords
- Spastic Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 9 Feb 2023 (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.
Cerebral palsy (CP) is a disorder characterized by abnormal tone, posture and movement and clinically classified based on the predominant motor syndrome-spastic hemiplegia, spastic diplegia, spastic quadriplegia, and extra-pyramidal or dyskinetic. Clinical prediction models and neuroimaging have been used to diagnose CP before the age of 2 years, but further research is necessary. Cuevas Medek Exercises (CME) is a pediatric physiotherapy approach for children with developmental motor delay impacting the central nervous system. According to Ramon Cuevas, who developed the therapy, CME are mainly based on the principle of provoking novel automatic motor reactions using exercises against gravity with progressive distal holding. This study will find the effects of Cuevas Medak Exercises on Balance and Postural control in children with spastic cerebral palsy.
This Randomized Controlled Trial will recruit the participants through random sampling. Participants will be randomly divided into 2 groups. Two groups of children aged between 2 and 5 years, suffering from cerebral palsy in spastic form, one for control and one for experiment. Controlled will get conventional treatment while study group will get conventional treatment with Cuevas Medak Exercises. Treatment duration is of 12 weeks. Progress will 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 static balance test. Data will be analyzed through SPSS 25.
Detailed description
Cerebral palsy (CP) is a disorder characterized by abnormal tone, posture and movement and clinically classified based on the predominant motor syndrome-spastic hemiplegia, spastic diplegia, spastic quadriplegia, and extra-pyramidal or dyskinetic (1). Children born preterm account for one-third to one-half of CP diagnoses in HICs, although this proportion is much lower in low-income countries (LICs), where mortality of very preterm babies remains high . Clinical prediction models and neuroimaging have been used to diagnose CP before the age of 2 years, but further research is necessary (.
The CPs share a common clinical sign of non-progressive dysfunction of posture and movement control but not a common diagnosis. Although there are many CP types, many causes, and now many associated pathogenic genetic variants, it is probably not advisable to change the clinical diagnosis of CP made by specialist pediatricians in cases that fulfill the clinical definition.
In order to prevent greater developmental motor delay, a physiotherapy intervention focusing on optimizing neuroplasticity must be done, stimulating the child to achieve the developmental motor milestones . Cuevas Medek Exercises (CME) is a pediatric physiotherapy approach for children with developmental motor delay impacting the central nervous system. According to Ramon Cuevas, who developed the therapy, CME are mainly based on the principle of provoking novel automatic motor reactions using exercises against gravity with progressive distal holding CME therapy is a physiotherapy approach to treat children with developmental motor delay by impacting CNS. Postural control and balance training are essentials for the children to be mobile. The aim of the study is to find the effects of Cuevas Medek Exercises on balance and postural control on children with spastic Cerebral Palsy so that the children with motor development disorders of neurological cause like cerebral palsy can develop automatic motor reactions which they would not be able to develop on their own, because of neurological injuries and help them to improve their quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CUEVAS MEDEK EXERCISES | Experimental | Other: CUEVAS MEDEK EXERCISESExperimental group will get conventional treatment along with Cuevas Medak Exercises |
| BALANCE AND POSTURAL | Other | Other: BALANCE AND POSTURALControlled will get conventional treatment |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children with medical diagnosis of Spastic Cerebral Palsy
- Age ranging from 2 to 5 years.
- Children who will able to stand and walk
Key exclusion criteria (3 listed)
- Children with planned surgical or medical surgeries during study period
- Children with impaired cognition
- Children with hearing impairment and visual impairment
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 EXERCISESAlso: Conventional Physical therapystretchings/strengthening | Other | CUEVAS MEDEK EXERCISES |
| BALANCE AND POSTURALBALANCE AND POSTURAL | Other | BALANCE AND POSTURAL |
Primary outcome
pediatric balance scale
Time frame: 12 weeks
The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points
1 secondary outcome
static balance test.
Time frame: 12 weeks
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 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Spastic Cerebral Palsy
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Telerehabilitation Compared With Clinic-Based Physiotherapy in Children With Spastic Cerebral Palsy
Spastic Cerebral Palsy
Not yet recruiting
Video-based Visual Feedback Combined With Task-oriented Physiotherapy Among Cerebral Palsy
Cerebral Palsy (CP)
Recruiting
Intrathecal Baclofen and Pediatric Dystonia
Dystonic Cerebral Palsy
Not yet recruitingObservational study
Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
Cerebral Palsy Infantile, Upper Limb Spasticity
Recruiting
Short-Term Effects of Manual Therapy Prior to Neuromotor Therapy in Children With Cerebral Palsy
Cerebral Palsy (CP), Unilateral Spastic Cerebral Palsy
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.
Sara khan, 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 EXERCISES and BALANCE AND POSTURAL in people with Spastic Cerebral Palsy, 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 3 inclusion and 3 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 Oct 2023. 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2023.