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RecruitingNCT06673849Updated Nov 5, 2024

Rhythmic Stabilization Versus Ball Balancing

An interventional study of Rhythmic Stabilization and Ball Balancing in Spastic Cerebral Palsy (sCP), sponsored by Riphah International University. Recruiting at 1 site in Pakistan. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2024-11-05.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Sep 2024; still recruiting 2 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
6 Years to 12 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Spastic Cerebral Palsy (sCP)

Keywords

  • Ball Balancing
  • Corticobulbar tracts
  • Corticospinal tracts
  • Epilepsy
  • Rhythmic Stabilization
  • Spastic CP
03

In context

Muscle Spasticity

704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.

This study's planned enrollment of 36 is close to the median of 36 across 525 interventional studies indexed under Muscle Spasticity.

Browse Muscle Spasticity studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Children with any other neurological impairment
  • Children with audio visual impairment
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    Rhythmic Stabilization group

    The CP child will positions his/her upper extremity anywhere in its available range of motion and holds an isometric contraction. The physiotherapist will provide enough resistance to cause the child to react, but not enough to break the isometric contraction. As the child progresses, length of time of rhythmic stabilization increases, the therapist's resistance increases, and amount of contact area between therapist's hands and child's upper extremity decreases. The exercise program consisted of 30-minute sessions per week for six weeks

    Other: Rhythmic Stabilization

  • Experimental
    Ball Balancing group

    Have the child balance on his/her hands on a 48-inch Gymnastic ball, first with eyes open, then closed. Progress from both hands on one large ball to each hand on separate balls and then to the weaker arm on one ball. Also, progress through the four body positions. With his/her eyes open, then closed. If he/she misses the position, he/she opens his/her eyes and actively moves to the desired position. Use a spotter, especially when doing this exercise for the first time or changing body positions, since the patient may fall off the Gymnastic ball. Start with one repetition of 10 seconds and progress to three to five repetitions of 60 seconds each and this will be done till 6 weeks

    Other: Ball Balancing

Interventions

  • OtherRhythmic 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 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.

  • OtherBall 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 through four body positions with eyes open, then closed. 5. Correction: If the child misses a position, they open their eyes and reposition actively.

06

What researchers measure

Primary outcomes

  1. QUEST ( Quality of Upper Extremity Skills Test)

    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.

    Time frame: 6 weeks

  2. SHUEE Scale

    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

    Time frame: 6 weeks

07

Study locations

1 of 1 sites recruiting
  • Riphah International University
    Lahore, Punjab 54700, Pakistan
    Recruiting
08

References and documents

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. PubMed 32206590 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06673849
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
Nov 5, 2024
Start date
Sep 25, 2024
Primary completion
Dec 2, 2024 (estimated)
Completion
Jan 2, 2025 (estimated)
Last update
Nov 5, 2024

Study contacts

Imran Amjad, PhD
Contact
Imran.amjad@riphah.edu.pk
9233224390125
Muhammad Asif Javed, MS
Contact
a.javed@riphah.edu.pk
03224209422
Masifah Kashif, MS*
principal investigator · Riphah International University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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