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CompletedNCT06966609Updated May 13, 2025

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

An interventional study of Control Group and Experimental Group in Spastic Diplegia Cerebral Palsy, Quality of Lifte and Motor Function, sponsored by Foundation University Islamabad. Completed at 1 site in Pakistan. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-05-13.

Sponsored by Foundation University Islamabad · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Jun 2024, registered May 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
6 Years to 12 Years
Sex
All
01

Study 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.

Read the 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\<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\<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\>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\>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:

  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.
02

Conditions studied

  • Spastic Diplegia Cerebral Palsy
  • Quality of Lifte
  • Motor Function

Keywords

  • Spastic Diplegic Cerebral Palsy
  • Gross motor proficiency
  • quality of life
03

In context

Muscle Spasticity

704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.

This study's enrollment of 56 is above the median of 36 across 525 interventional studies indexed under Muscle Spasticity.

Browse Muscle Spasticity studies →

Lead sponsor

Foundation University Islamabad is the lead sponsor of 238 studies on the registry; 128 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion criteria:

  • diagnosed cognitive impairment
  • diagnosed hearing impairment and visual impairment
  • children with planned surgical procedures during study period
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    Interventional Group A

    It includes participants receiving cuevas medek exercise combined with conventional physical therapy for 12 weeks treatment. 1. Stretching Exercises (PNF stretching) * 0-6 weeks; 3 sets (5 repetition of 20sec) 4 times a week * 6-12 weeks; 3 sets(10 repetition of 60sec) 4 times a week * Muscles included: Flexors (hip, knee, ankle), extensors (hip, knee, ankle), abductor(hip) and adductors(hip) 2. Strengthening Exercises (Isometric muscle strengthening ) * 3 sets ( 10 repetition) * Rest interval: 1min * Frequency: 3 times a week * Muscles included: Flexors(hip, knee, ankle), extensors(hip, knee, ankle), abductor(hip) and adductors(hip) 3. Gait training Parallel bar walking 4. Cuevas Medek Exercise(99 exercises) * Frequency: 3 times a week * Duration: 45mins * Repetition: 3-8 times * Exercises divided into following, will be administered according to patient need/goal; 1. Head control 2. Trunk control 3. Trunk and hip control 4. Coordination 5. Balance reaction 6. Stability

    Procedure: Experimental Group

  • Active comparator
    Interventional Group B

    It includes participants receiving conventional physical therapy for 12 weeks treatment. 1. Stretching Exercises (PNF stretching) * 0-6 weeks; 3 sets (5 repetition of 20sec) 4 times a week * 6-12 weeks; 3 sets(10 repetition of 60sec) 4 times a week * Muscles included: Flexors (hip, knee, ankle), extensors (hip, knee, ankle), abductor(hip) and adductors(hip) 2. Strengthening Exercises (Isometric muscle strengthening ) * 3 sets ( 10 repetition) * Rest interval: 1min * Frequency: 3 times a week * Muscles included: Flexors(hip, knee, ankle), extensors(hip, knee, ankle), abductor(hip) and adductors(hip) 3. Gait training Parallel bar walking Treatment time: 45mins

    Procedure: Control Group

Interventions

  • ProcedureControl Group

    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.

  • ProcedureExperimental Group

    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.

06

What researchers measure

Primary outcomes

  1. Gross Motor Function

    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.

    Time frame: 12 weeks

  2. Quality of Life

    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.

    Time frame: 12 weeks

07

Study locations

1 site
  • Foundation University College of Physical Thrapy
    Islamabad, 44000, Pakistan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06966609
Lead sponsor
Foundation University Islamabad
Responsible party
Sponsor
First posted
May 13, 2025
Start date
Jun 10, 2024
Primary completion
Dec 1, 2024
Completion
Dec 20, 2024
Last update
May 13, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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