Comparison of the Effects of Vojta and Bobath Treatment on Gait and Balance in Diplegic Cerebral Palsy

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 3 to 8 years
• All sexes
• No healthy volunteers
• Child

Trial locations and contacts

1 site in 1 country.

About this study

Official title: Comparison of the Effects of Vojta and Bobath Treatment on Gait and Balance in Diplegic Cerebral Palsy.

Conditions

Cerebral Palsy Spastic Diplegia

Being tested

Vojta Therapy, Bobath Therapy, Combined Vojta and Bobath Therapy

Keywords

Cerebral palsy, Bobath Therapy, Vojta Therapy, balance, gait

Medical subject headings

Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Vojta TherapyOther

  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.

• Bobath TherapyOther

  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.

• Combined Vojta and Bobath TherapyOther

  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 being measured

The primary outcome is the main question the study is designed to answer.

1. Gross Motor Functional Classification System (GMFCS)

   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 \&amp; 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.

   Measured: 8 weeks

2. Goniometer

   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.

   Measured: 8 weeks

3. Paediatric Berg Balance Scale

   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)].

   Measured: 8 weeks

4. Step Length

   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.

   Measured: 8 weeks

5. Stride Length

   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.

   Measured: 8 weeks

6. Cadence

   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.

   Measured: 8 weeks

7. Walking Base

   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.

   Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted3 Jan 2025
2. Study start25 Aug 2023
3. Primary completion25 Feb 2024
4. Study completion25 Feb 2024

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Cerebral Palsy Spastic DiplegiaStudies of the same condition, open and under way.
• More trials run by Riphah International UniversityThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.