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

NCT06757101 | Completed

• 1 other identifier: Unsa Baloch/ 01641
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Palsy Spastic Diplegia

Keywords

Cerebral palsy; Bobath Therapy; Vojta Therapy; balance; gait

Outcome Measures

Primary Outcomes (7)

• 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.

  8 weeks

• 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.

  8 weeks

• 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 \[(ICC3, 1=0.9987)\].

  8 weeks

• 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.

  8 weeks

• 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.

  8 weeks

• 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.

  8 weeks

• 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.

  8 weeks

Study Arms (3)

Vojta Therapy group

EXPERIMENTAL

Vojta Therapy group for gait \& balance

Other: Vojta Therapy

Bobath Therapy group

EXPERIMENTAL

Bobath Therapy group for gait \& balance

Other: Bobath Therapy

Combined Vojta and Bobath therapy

EXPERIMENTAL

Combined Vojta and Bobath therapy for gait \& balance

Other: Combined Vojta and Bobath Therapy

Interventions

Vojta Therapy OTHER

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.

Vojta Therapy group

Bobath Therapy OTHER

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.

Bobath Therapy group

Combined Vojta and Bobath Therapy OTHER

Combined Vojta and Bobath exercises along with the conventional treatment. Frequency of exercises will be 2 times a week, duration 40 minutes per day.

Combined Vojta and Bobath therapy

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Child Development Center

Rawalpindi, Punjab Province, 46060, Pakistan

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Abrish Habib Abbasi, MS-NMPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2023
• First Posted: January 3, 2025
• Study Start: August 25, 2023
• Primary Completion: February 25, 2024
• Study Completion: February 25, 2024
• Last Updated: January 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)