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NCT Number: 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

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.

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Key information

Conditions

Spastic Diplegia Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Cerebral palsy, spastic, diplegic Motor Function Nervous System Diseases Quality of Lifte

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foundation University College of Physical Thrapy

Islamabad, 44000, Pakistan

About this study

OBJECTIVES:

The objectives of this study are:

  • To determine the additional effect of Cuevas Medek Exercises with conventional exercises on gross motor proficiency in children with spastic diplegic cerebral palsy.
  • 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:

  • 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<0.05)
  • 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<0.05)

Null Hypothesis:

  • 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>0.05)
  • 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>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 & 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:

  • Gross motor function measure
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosed spastic diplegic cerebral palsy children
  • age group 6-12 years old
  • both male and female
  • GMFCS II & 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

Treatment and study plan

Control Group

Procedure

Conventional Physical Therapy ( 12 weeks intervention) 24 randomly allocated participants will get the conventional physical therapy that includes the stretching exercises (PNF technique) for 6 weeks; targeting all the affected lower limb muscles, strengthening exercises of all the weak lower limb muscles for 12 weeks along with gait training on parallel bars. Duration of session is 45 min.

Experimental group

Procedure

Conventional Physical Therapy and Cuevas Medek Exercises ( 12 weeks intervention) 24 randomly allocated participants will get the conventional physical therapy that includes the stretching exercises (PNF technique) for 6 weeks; targeting all the affected lower limb muscles, strengthening exercises of all the weak lower limb muscles for 12 weeks along with gait training on parallel bars.Along with conventional physical therapy, experimental group participants will get Cuevas Medek Exercises that includes antigravity exercises, specefic types of stretchings and balancing exercises. Types of exercises that will be performed on the patient out of 100 exercises,will depend on the patient's need that is affecting his or her gross motor proficiency.Total duration of session is 90 min.

Primary outcomes

  1. Gross Motor Function

    Time frame: 12 weeks

    Gross Motor Function Measure-88 score, will be used to assess gross motor function in children with cerebral palsy. It is a four point scale, consists of 88 items divided into five dimensions of gross motor function: a. lying and rolling, b. crawling and kneeling, c. sitting, d. standing, e. walking, running and jumping. It takes about 45 to 60 minutes. Equipments required for this measure tool are; mat, bench, toy and access to stairs.

    Item scores are summed to calculate raw and percent scores for each of the five dimensions. Then, Average the percent scores for each dimension to get the total score. Total score (in percent), will be compared on each assessment to find out the improvement in the individual through that specefic intervention.

  2. Quality of Life

    Time frame: 12 weeks

    CP QOL Child Primary Caregiver It is a validated questionnaire that assesses the subjective well- being and happiness of children with CP. It consist of 66 questions and should be answered by caregivers of CP child, who report their perception of their child's quality of life of areas: well being and social acceptance, functionality, participation and physical health, emotional well being and self esteem, access to services, pain and disability impact and family health. The questionnaire is scored by summing the items to get a total score, with higher scores representing better quality of life.

Sponsors and collaborators

Lead sponsor

Foundation University Islamabad

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 13, 2025
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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