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

NCT ID: NCT06966609

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-10
• Study Completion Date: 2024-12-20

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<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.

Conditions

Spastic Diplegia Cerebral Palsy; Quality of Lifte; Motor Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Experimental Group

Intervention Type: 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 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

Group Type: ACTIVE_COMPARATOR

Control Group

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Experimental 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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Foundation University Islamabad

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Foundation University College of Physical Thrapy

Islamabad, , Pakistan

Countries

Pakistan

Other Identifiers

FUI/CTR/2024/36

Identifier Type: -

Identifier Source: org_study_id