Cuevas Medek Exercises on Balance and Postural Control in Children With Spastic Cerebral Palsy
Primary Purpose
Spastic Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
CUEVAS MEDEK EXERCISES
BALANCE AND POSTURAL
Sponsored by
About this trial
This is an interventional treatment trial for Spastic Cerebral Palsy focused on measuring Spastic Cerebral Palsy
Eligibility Criteria
Inclusion Criteria: Children with medical diagnosis of Spastic Cerebral Palsy Age ranging from 2 to 5 years. Children who will able to stand and walk Exclusion Criteria: Children with planned surgical or medical surgeries during study period Children with impaired cognition Children with hearing impairment and visual impairment
Sites / Locations
- Helping Hands Organization (HHRD) Bahawalpur.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
CUEVAS MEDEK EXERCISES
BALANCE AND POSTURAL
Arm Description
Experimental group will get conventional treatment along with Cuevas Medak Exercises
Controlled will get conventional treatment
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT05719623
First Posted
January 31, 2023
Last Updated
October 11, 2023
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05719623
Brief Title
Cuevas Medek Exercises on Balance and Postural Control in Children With Spastic Cerebral Palsy
Official Title
Effects of Cuevas Medek Exercises on Balance and Postural Control in Children With Spastic Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
February 9, 2023 (Actual)
Primary Completion Date
August 31, 2023 (Actual)
Study Completion Date
September 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spastic Cerebral Palsy
Keywords
Spastic Cerebral Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CUEVAS MEDEK EXERCISES
Arm Type
Experimental
Arm Description
Experimental group will get conventional treatment along with Cuevas Medak Exercises
Arm Title
BALANCE AND POSTURAL
Arm Type
Other
Arm Description
Controlled will get conventional treatment
Intervention Type
Other
Intervention Name(s)
CUEVAS MEDEK EXERCISES
Other Intervention Name(s)
Conventional Physical therapy
Intervention Description
stretchings/strengthening
Intervention Type
Other
Intervention Name(s)
BALANCE AND POSTURAL
Intervention Description
BALANCE AND POSTURAL
Primary Outcome Measure Information:
Title
pediatric balance scale
Description
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
static balance test.
Description
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).
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Children with medical diagnosis of Spastic Cerebral Palsy
Age ranging from 2 to 5 years.
Children who will able to stand and walk
Exclusion Criteria:
Children with planned surgical or medical surgeries during study period
Children with impaired cognition
Children with hearing impairment and visual impairment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara khan, MS
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helping Hands Organization (HHRD) Bahawalpur.
City
Bahawalpur.
State/Province
Punjab
ZIP/Postal Code
63080.
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cuevas Medek Exercises on Balance and Postural Control in Children With Spastic Cerebral Palsy
We'll reach out to this number within 24 hrs