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

NCT06966609 | Completed

• 1 other identifier: FUI/CTR/2024/36
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Spastic Diplegia Cerebral Palsy; Quality of Lifte; Motor Function

Keywords

Spastic Diplegic Cerebral Palsy; Gross motor proficiency; quality of life

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12 weeks

Study Arms (2)

Interventional Group A

EXPERIMENTAL

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

Interventional Group B

ACTIVE COMPARATOR

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

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.

Interventional Group B

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.

Interventional Group A

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Foundation University Islamabad: lead

Study Sites (1)

Foundation University College of Physical Thrapy

Islamabad, 44000, Pakistan

Location

MeSH Terms

Conditions

Cerebral palsy, spastic, diplegic; Cerebral Palsy

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2025
• First Posted: May 13, 2025
• Study Start: June 10, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 20, 2024
• Last Updated: May 13, 2025

Record last verified: 2025-05

Locations

PA (1)