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Recruiting NCT06673849

Rhythmic Stabilization Versus Ball Balancing

No phase Interventional Spastic Cerebral Palsy (sCP)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rhythmic Stabilization, Ball Balancing.
Who it may be relevant to
Registry conditions: Spastic Cerebral Palsy (sCP). Basic parameters: 6 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Other Rhythmic Stabilization
    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 res
  • Other Ball Balancing
    Ball Balancing Program Objective: Improve balance and stability. Equipment: 48-inch gymnastic ball Program Details: * Duration: 6 weeks * Frequency: As needed Steps: 1. Initial Balance: * Eyes Open: Balance on hands for 10 seconds. * Progression: Increase to 3-5 repetitions of 60 seconds. 2. Eyes Closed: Repeat the above exercise with eyes closed. 3. Variations: * Both Hands on One Ball * Each Hand on Separate Balls * Weaker Arm on One Ball 4. Body Positions: Progress throug

Primary outcome measures

  • QUEST ( Quality of Upper Extremity Skills Test) [Time frame: 6 weeks]
  • SHUEE Scale [Time frame: 6 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • Riphah International University — Lahore

Publications

  • Patel DR, Neelakantan M, Pandher K, Merrick J. Cerebral palsy in children: a clinical overview. Transl Pediatr. 2020 Feb;9(Suppl 1):S125-S135. doi: 10.21037/tp.2020.01.01. PMID 32206590

Identifiers

NCT: NCT06673849 · REC/RCR/AHS/24/MASIFAH

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗