- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06673849
Rhythmic Stabilization Versus Ball Balancing
Effects of Rhythmic Stabilization Versus Ball Balancing on Upper Extremity Function in Children With Spastic Cerebral Palsy
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Muhammad Asif Javed, MS
- Phone Number: 03224209422
- Email: a.javed@riphah.edu.pk
Study Contact Backup
- Name: IMRAN AMJAD, PhD
- Phone Number: 9233224390125
- Email: imran.amjad@riphah.edu.pk
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54700
- Recruiting
- Riphah International University
-
Contact:
- Muhammad Asif Javed, MS
- Phone Number: 03224209422
- Email: a.javed@riphah.edu.pk
-
Contact:
- IMRAN AMJAD, PhD
- Phone Number: 9233224390125
- Email: imran.amjad@riphah.edu.pk
-
Principal Investigator:
- Masifah Kashif, MS*
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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
|
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. |
|
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
|
Ball Balancing Program Objective: Improve balance and stability. Equipment: 48-inch gymnastic ball Program Details:
Steps:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 weeks
|
|
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
|
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Masifah Kashif, MS*, Riphah International University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR/AHS/24/MASIFAH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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