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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Pakistan
    • Punjab
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Vojta Therapy group
Vojta Therapy group for gait & balance
Other: Vojta Therapy
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
Other: Bobath Therapy
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
Other: Combined Vojta and Bobath Therapy
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 25, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 25, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 25, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 1, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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