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
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.
OBJECTIVES:
The objectives of this study are:
HYPOTHESIS:
Alternate Hypothesis:
Null Hypothesis:
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
Exclusion Criteria
Sampling technique: convenicence sampling
Outcome Measures:
Data analysis techniques:
Data will be analyzed using SPSS version 20.0.0.
Significance of the study:
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 →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.
Exclusion criteria:
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
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
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.
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.
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
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
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Foundation University Islamabad