- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06757101
Comparison of the Effects of Vojta and Bobath Treatment on Gait and Balance in Diplegic Cerebral Palsy
January 1, 2025 updated by: Riphah International University
Comparison of the Effects of Vojta and Bobath Treatment on Gait and Balance in Diplegic Cerebral Palsy.
This study aims compare the effects of Vojta verses Bobath therapy on gait in children with diplegic cerebral palsy and to compare the effects of Vojta versus Bobath therapy on balance in children with diplegic cerebral palsy.
The study will also determine the combined effects of Vojta and Bobath on gait and balance in children with diplegic cerebral palsy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study may provide non-invasive and cost-effective treatment option in improving balance & gait in children with cerebral palsy.
This can increase the child independence, confidence and quality of life.
Additionally, this study may contribute to the development of evidence-based rehabilitation protocols, which can help guide clinical decision-making and treatment options.
The study may provide insight into the feasibility and safety of combining Vojta and Bobath treatments, which can guide future research and practice in this area.
Moreover, combination of treatments may have better outcomes as compared to the two individual techniques.
The study aims compare the effects of Vojta verses Bobath therapy on gait in children with diplegic cerebral palsy and to compare the effects of Vojta versus Bobath therapy on balance in children with diplegic cerebral palsy.
The study will also determine the combined effects of Vojta and Bobath on gait and balance in children with diplegic cerebral palsy.
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Punjab
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Rawalpindi, Punjab, Pakistan, 46060
- Child Development Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Diagnosed cases of spastic diplegic cerebral palsy
- GMFCS level II & III
- Modified Ashworth score greater than 1+
- Age 3-8 Years
- Either gender
- Children capable of understanding and executing commands;
- Children who can adopt the orthostatic position necessary to assess balance & gait
Exclusion Criteria:
- Children with any other associated disease (DDH, any orthopedic complication)
- Children with mental retardation;
- Who cannot participate constantly in physical therapy sessions;
- Profound visual or hearing impairments;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Vojta Therapy group
Vojta Therapy group for gait & balance
|
Exercises will be performed in supine, lateral, decubitus and reflex crawling.
Exercises will include Stretching's, ROMs Exercises, Stimulation of 10 different zones for locomotion & gentle pressure applied to stimulation areas.
Frequency of exercises will be 2 times a week, duration 40 minutes per day.
|
|
Experimental: Bobath Therapy group
Bobath Therapy group for gait & balance
|
Exercises will be performed in supine, lateral, prone and standing position.
Exercises includes stretching Exercises, ROMs, Quadruped imbalance exercise, Imbalance from the kneeling exercise, Cervant Knight exercise, Tandem walk, Kicking a ball, Step climbing, marching at one place with alternate foot Frequency of exercises will be 2 times a week, duration 40 minutes per day.
|
|
Experimental: Combined Vojta and Bobath therapy
Combined Vojta and Bobath therapy for gait & balance
|
Combined Vojta and Bobath exercises along with the conventional treatment.
Frequency of exercises will be 2 times a week, duration 40 minutes per day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gross Motor Functional Classification System (GMFCS)
Time Frame: 8 weeks
|
The Gross Motor Functional Classification System (GMFCS) is the assessment tool to measure motor function in children with cerebral palsy.
GMFCS is a five-level classification that differentiates children with Level I:Walks independently, Level II: Walks with limitations, Level III: Walks with hand- held mobility, Level IV: Self mobility with limitations, may use powered mobility & Level V: Transported in a manual wheelchair.
The inter-rater reliability of GMFCS have a moderate agreement with a kappa (k) of 0.55 in children <2 years of age and excellent agreement with a kappa of 0.75 in children 2-12 years of age.
This strong inter-rater reliability supports the use of the GMFCS as a classification of gross motor function in children ages 2-12 years.
|
8 weeks
|
|
Goniometer
Time Frame: 8 weeks
|
The Goniometer measures the angle created at a joint by the adjacent bones of the body.
Goniometer measurement represent the actual joint range of motion.
There are multiple types of goniometer but universal goniometer is widely used in physiotherapy settings.
|
8 weeks
|
|
Paediatric Berg Balance Scale
Time Frame: 8 weeks
|
The Paediatric Berg Balance Scale is used to assess functional balance skills in school-aged children.
The scale consists of 14 items that scored from 0 points (lowest function) to 4 (highest function) with a maximum score of 56 points.
Concurrent validity between Pediatric Balance Scale and GMFM at baseline (r=0.095),
follow-up (r=0.44-0.87).
Predictive validity of Pediatric validity and GMFM at follow-up (r=0.90-0.92)
The test retest reliability is extremely high [(ICC3, 1=0.9987)].
|
8 weeks
|
|
Step Length
Time Frame: 8 weeks
|
Step length is typically measured in centimeters (cm) or inches.
Step length is used in clinical settings to assess gait abnormalities and has implications for rehabilitation.
Adequate step length contributes to effective ambulation and helps maintain stability and momentum during walking.
|
8 weeks
|
|
Stride Length
Time Frame: 8 weeks
|
Stride length is a key parameter in gait analysis that refers to the distance covered in one complete cycle of walking or running, specifically the distance between the initial contact point of one foot and the initial contact point of the same foot on the next step.
Stride length is typically measured in units such as centimeters (cm) or inches.
Stride length is critical in clinical assessments for identifying gait abnormalities.
|
8 weeks
|
|
Cadence
Time Frame: 8 weeks
|
Cadence refers to the number of steps a person takes per unit of time, typically expressed as steps per minute (spm).
It is a critical metric in gait analysis, providing insights into walking or running patterns and overall locomotion efficiency.
A normal cadence (generally between 100 to 130 steps per minute for walking) is important for maintaining stability and rhythm during locomotion.
Abnormal cadence can lead to increased fall risk and affect overall mobility.
|
8 weeks
|
|
Walking Base
Time Frame: 8 weeks
|
Walking base, also known as base of support or stance width, refers to the distance between the feet when a person is walking.
Specifically, it is the lateral distance between the heel centers of both feet during the walking cycle.
A wider walking base indicates that the feet are positioned farther apart, while a narrower walking base means they are closer together.
Walking base is typically measured in centimeters (cm).Walking base is a significant parameter in the assessment of gait and balance, providing insights into an individual's stability and mobility.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Abrish Habib Abbasi, MS-NMPT, Riphah International University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 25, 2023
Primary Completion (Actual)
February 25, 2024
Study Completion (Actual)
February 25, 2024
Study Registration Dates
First Submitted
August 26, 2023
First Submitted That Met QC Criteria
January 1, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 1, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Unsa Baloch/ 01641
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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