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NCT Number: NCT06673849

Rhythmic Stabilization Versus Ball Balancing

Spastic Cerebral Palsy (CP) is the leading cause of upper motor neuron syndrome (UMN) in children. The primary factors contributing to motor behavior disorders in these children are impairments in motor control and muscle strength. These impairments result in changes in muscle growth and hinder the development of motor skills, leading to reduced muscle force generation and decreased flexibility. Spastic cerebral palsy is the most prevalent type, affecting 77% of individuals with CP, and is caused by damage to the motor cortex and pyramidal tracts. The motor cortex is responsible for transmitting voluntary movement signals from the brain to the muscles. Characteristics of spastic cerebral palsy include stiff muscles (hypertonia), which can cause jerky and repetitive limb movements (spasticity). Additionally, individuals with CP often have difficulties in processing somatosensory and proprioceptive information. Proprioceptive training refers to interventions aimed at enhancing proprioceptive function to ultimately improve motor performance, a concept that has been explored in studies focused on sports injuries. In this study, we will utilize two proprioceptive exercises-rhythmic stabilization and ball balancing-to promote functional improvement in the upper extremities of children with spastic CP.

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Key information

Conditions

Spastic Cerebral Palsy (sCP) Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Epilepsy Nervous System Diseases

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

There will be two groups: Group A will consist of 16 patients undergoing rhythmic stabilization, while Group B will also have 16 patients participating in ball balancing activities. Data will be collected both before and after the intervention to determine the most effective approach. Data analysis will be conducted using SPSS version 23.00.

This study will be a randomized clinical trial, with data collected from the University of Lahore Teaching Hospital (ULTH) and the Pakistan Society for the Rehabilitation of the Disabled (PSRD) in Lahore. A total of 32 patients will participate, equally divided into two groups through random allocation. The inclusion criteria will consist of children aged 5-12 with spastic CP, encompassing both genders. Patients with any neurological conditions, other orthopedic issues, a history of spine surgery, severe systemic disorders, psychiatric disorders, or neuromuscular disorders will be excluded from the study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Spastic diplegic CP children age 6 to 12 years,
  • Each gender included
  • Grade 1 of spasticity according to modified Ashworth scale (21)
  • With normal I.Q. greater than 70 (assessed by psychologist),
  • Can follow commands(

Exclusion criteria

  • Children with any other neurological impairment
  • Children with audio visual impairment

Treatment and study plan

Rhythmic Stabilization

Other

Rhythmic Stabilization Program for Children with Cerebral Palsy Objective: Enhance upper extremity strength and stability through rhythmic stabilization exercises.

Program Overview:

Duration: 30-minute sessions Frequency: Once per week for 6 weeks

Exercise Steps:

Positioning: The child positions their upper extremity within their available range of motion.

Isometric Contraction: The child holds an isometric contraction, maintaining the position without movement.

Therapist's Role: Apply resistance that is sufficient to elicit a reaction but not enough to disrupt the isometric contraction.

Progression: Gradually increase the duration of the isometric hold. Increase the amount of resistance applied. Decrease the contact area between the therapist's hands and the child's upper extremity to enhance stability challenges. Monitoring and Adjustments: Assess the child's ability to maintain the contraction and adapt the resistance and support as needed. Encourage the child's engagement.

Ball Balancing

Other

Ball Balancing Program Objective: Improve balance and stability. Equipment: 48-inch gymnastic ball

Program Details:

  • Duration: 6 weeks
  • Frequency: As needed

Steps:

  • Initial Balance:
  • Eyes Open: Balance on hands for 10 seconds.
  • Progression: Increase to 3-5 repetitions of 60 seconds.
  • Eyes Closed: Repeat the above exercise with eyes closed.
  • Variations:
  • Both Hands on One Ball
  • Each Hand on Separate Balls
  • Weaker Arm on One Ball
  • Body Positions: Progress through four body positions with eyes open, then closed.
  • Correction: If the child misses a position, they open their eyes and reposition actively.

Primary outcomes

  1. QUEST ( Quality of Upper Extremity Skills Test)

    Time frame: 6 weeks

    The Quality of Upper Extremity Skills Test (QUEST) is a reliable and valid tool that assesses hand function and movement patterns in children with cerebral palsy. It can be used with children aged 6 to 12 years (23). The test is conducted in a play environment and consists of 34 activity items. The test assesses four domains: Dissociated movements, Grasp, Protective extension. Reliability is 0.96 and validity is 0.84.

  2. SHUEE Scale

    Time frame: 6 weeks

    The Shriners Hospital for Children Upper Extremity Evaluation (SHUEE) is a video-based tool for the assessment of upper extremity function in children with hemiplegic cerebral palsy. This tool includes spontaneous functional analysis and Effects of Rhythmic Stabilization versus Ball Balancing on Spastic CP 3dynamic positional analysis and assesses the ability to perform grasp and release. The validity is 0.47 and reliability is 0.99

Study contacts

Contact information is provided by the study sponsor or research team.

Imran Amjad, PhD

CONTACT

[email protected]

9233224390125

Muhammad Asif Javed, MS

CONTACT

[email protected]

03224209422

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Rhythmic Stabilization Versus Ball Balancing on Upper Extremity Function in Children With Spastic Cerebral Palsy

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Nov 5, 2024
Registry last updated
Nov 5, 2024

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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