Clinical trial NCT06966609: Additional Effects of Cuevas Medek Exercises Along With Conventional Physical Therapy on Gross Motor Proficiency and Quality of Life, in Children With Spastic Diplegic Cerebral Palsy
Official title: Additional Effects of Cuevas Medek Exercises Along With Conventional Physical Therapy on Gross Motor Proficiency and Quality of Life, in Children With Spastic Diplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spastic Diplegia Cerebral Palsy
Quality of Lifte
Motor Function
Keywords: Spastic Diplegic Cerebral Palsy
Gross motor proficiency
quality of life
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 56
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cerebral palsy (CP) is a prevalent pediatric neurological disorder hindering movement and posture development due to non-progressive disruptions in brain development. Motor disorders along with dysfunctions in sensations, perception, cognition, communication, behavior and secondary musculoskeletal problems are also present in children with CP.

Cuevas Medek Exercises (CME) is an innovative, intensive and dynamic therapy approach for management of movement disorders. It evoke automatic postural responses in children with motor delay problems by application of distal support, triggering stronger gravity induced reactions to enhanced motor output by compelling both mind and body responses.

It incorporates antigravity posture, ROM, weight-bearing, and stretching into functional exercises; for improved agility, flexibility, balance and coordination.

Detailed description: OBJECTIVES:

The objectives of this study are:

1. To determine the additional effect of Cuevas Medek Exercises with conventional exercises on gross motor proficiency in children with spastic diplegic cerebral palsy.
2. To determine the additional effect of Cuevas Medek Exercises with conventional exercises on quality of life of caregiver and children with spastic diplegic cerebral palsy.

HYPOTHESIS:

Alternate Hypothesis:

1. There is a statistically significant effect of Cuevas Medek Exercises in conjunction with conventional physical therapy as compared to conventional physical therapy alone on gross motor proficiency in children with spastic diplegic cerebral palsy. (p\&amp;lt;0.05)
2. There is a statistically significant effect of Cuevas Medek Exercises in conjunction with conventional physical therapy as compared to conventional physical therapy alone on quality of life in children with spastic diplegic cerebral palsy. (p\&amp;lt;0.05)

Null Hypothesis:

1. There is a statistically no significant effect of Cuevas Medek Exercises in conjunction with conventional physical therapy as compared to conventional physical therapy alone on gross motor proficiency in children with spastic diplegic cerebral palsy. (p\&amp;gt;0.05)
2. There is a statistically no significant effect of Cuevas Medek Exercises in conjunction with conventional physical therapy as compared to conventional physical therapy alone on quality of life in children with spastic diplegic cerebral palsy. (p\&amp;gt;0.05)

Research Design: Experimental study. Randomized Control Trial

Clinical setting: Fauji Foundation Hospital Study duration 1 year following synopsis approval.(Feb 2024- Jan 2025)

Selection Criteria:

Inclusion Criteria

* diagnosed spastic diplegic cerebral palsy children
* age group 6-12 years old
* both male and female
* GMFCS II \&amp;amp; III
* parents of spastic diplegic CP child

Exclusion Criteria

* diagnosed cognitive impairment
* diagnosed hearing impairment and visual impairment
* children with planned surgical procedures during study period

Sampling technique: convenicence sampling

Outcome Measures:

1. Gross motor function measure
2. CP QOL - CHILD

Data analysis techniques:

Data will be analyzed using SPSS version 20.0.0.

Significance of the study:

* Till date no study has yet evaluated the effect of Cuevas Medek Exrcises on gross motor proficiency and quality of life in children with spastic diplegic cerebral palsy. Therefore, advancement in the scientific knowledge can be achieved.
* Caregivers of cerebral palsy suffer from a substantial psychosocial burden. Therefore, to determine whether CME Therapy effects functional dependency and quality of life of both patient and caregivers.
* This study will contribute to future research directions and encouraging further exploration of CME Therapy as a promising intervention for spastic diplegic cerebral palsy.

Eligibility criteria: Inclusion Criteria:

* diagnosed spastic diplegic cerebral palsy children
* age group 6-12 years old
* both male and female
* GMFCS II \&amp; III
* parents of spastic diplegic CP child

Exclusion criteria:

* diagnosed cognitive impairment
* diagnosed hearing impairment and visual impairment
* children with planned surgical procedures during study period

Primary outcomes:
measure: Gross Motor Function
timeFrame: 12 weeks
measure: Quality of Life
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Foundation University College of Physical Thrapy
Study officials:
References: