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Effects of Bobath Technique Versus Task Oriented Training on Gross Motor Function in Cerebral Palsy Children

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
BOBATH technique
Task training
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

3 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male and female patient Age 3- 10 years. Diagnosed with CP by a specialist. Children with CP GMFCS level I-II. Types of Cerebral palsy (spastic diplegic, quadriplegic, hemiplegic,) without severe abnormalities Cognitive ability should be sufficient that he/she follow simple verbal commands and instructions during training

Exclusion Criteria:

Patient with fixed contracture Patient receiving treatment that affects motor function such as botulinum injection and orthopedic surgery

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Sites / Locations

  • Allied Hospital Faisalabad

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

BOBATH technique

Task training

Arm Description

In group A (BOBATH) one session per day for three days lasting 1 hour for 3 months. Position transitions such as turning from supine to prone or from prone to supine from sitting to standing are facilitated according to the needs. Balance reflexes are attempted to stimulate by using a CP ball. Ambulation training appropriate to the child's motor development. Additionally, passive stretching of spastic muscle reduces spasticity and facilitates the motor function

In group B (task training) will be applied for 60 minutes per day, 3 times per week for 3 months the individual session lasted roughly 10 minutes for each activity. Standing from a seated situation; (ii) reaching for an object high up, which required ankle plantarflexion from the standing position, and go back to the starting position with the heel leaning on the floor; (iii) stepping on and off a bench; (iv) walking up and downstairs. (10) (v) Drinking water hold the cup stable and drink it by lifting it at an appropriate speed and power (vi) Moving a rubber ball, the task involved taking a 6.5 cm diameter rubber ball and placing it in a basket with a diameter of ten cm (the basket location was moved in various directions).

Outcomes

Primary Outcome Measures

Gross Motor Function Measure (GMFM-88)
The Gross Motor Function Measure (GMFM) is an observational clinical tool designed to evaluate change in gross motor function in children with cerebral palsy. The GMFM-88 item scores can be summed to calculate raw and percent scores for each of the five GMFM dimensions of interest selected goal areas and total GMFM-88 scores. The scoring system of the GMFM is a four-point scale divided into five categories (lying and rolling; sitting; crawling and kneeling; standing; walking, running) Reliability refers to dependability, consistency, and stability of scores on an assessment tool. Both versions of GMFM were shown to be highly reliable, with ICCs of greater than .98 (95% confidence interval=0.965-0.994) and both of them can be used in clinical practice or research.

Secondary Outcome Measures

Full Information

First Posted
November 5, 2021
Last Updated
April 11, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05123937
Brief Title
Effects of Bobath Technique Versus Task Oriented Training on Gross Motor Function in Cerebral Palsy Children
Official Title
Effects of Bobath Technique Versus Task Oriented Training on Gross Motor Function in Cerebral Palsy Children
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
December 15, 2021 (Actual)
Study Completion Date
January 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Cerebral palsy is the most familiar motor disorder of childhood. Consistent with the results of recent scientific researches BOBATH approach in physical restoration of youngsters with cerebral palsy promotes formation of motor skills. Improvement in mobility has been primary goal in treatment of CP. There are only a few studies available within the efficacy of "task-oriented training" to improve gross motor function in CP child. Hence, this comparative study is undertaken to gauge the effect of task-oriented training verses neurodevelopmental training on gross motor function in cerebral palsy child. Objective of this study is to find out the effects of BOBATH technique and Task Training on gross motor function in cerebral palsy children. A Convenient sample of Cerebral Palsy children fulfilling inclusion and exclusion criteria, from physiotherapy OPD of Allied & DHQ hospitals of Faisalabad will be considered. Informed consent will be taken from all patient's caregivers. Patients will be divided into two groups through chit draw randomization. Age of children will be 3 years to 10 years without discrimination of gender. Group A will receive BOBATH training and Group B will receive task training. Data will be collected through Gross Motor Function Measure (GMFM-88). Data analyses using SPSS version 25 as a statistical tool.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BOBATH technique
Arm Type
Experimental
Arm Description
In group A (BOBATH) one session per day for three days lasting 1 hour for 3 months. Position transitions such as turning from supine to prone or from prone to supine from sitting to standing are facilitated according to the needs. Balance reflexes are attempted to stimulate by using a CP ball. Ambulation training appropriate to the child's motor development. Additionally, passive stretching of spastic muscle reduces spasticity and facilitates the motor function
Arm Title
Task training
Arm Type
Experimental
Arm Description
In group B (task training) will be applied for 60 minutes per day, 3 times per week for 3 months the individual session lasted roughly 10 minutes for each activity. Standing from a seated situation; (ii) reaching for an object high up, which required ankle plantarflexion from the standing position, and go back to the starting position with the heel leaning on the floor; (iii) stepping on and off a bench; (iv) walking up and downstairs. (10) (v) Drinking water hold the cup stable and drink it by lifting it at an appropriate speed and power (vi) Moving a rubber ball, the task involved taking a 6.5 cm diameter rubber ball and placing it in a basket with a diameter of ten cm (the basket location was moved in various directions).
Intervention Type
Other
Intervention Name(s)
BOBATH technique
Intervention Description
In group A (BOBATH) one session per day for three days lasting 1 hour for 3 months. Position transitions such as turning from supine to prone or from prone to supine from sitting to standing are facilitated according to the needs. Balance reflexes are attempted to stimulate by using a CP ball. Ambulation training appropriate to the child's motor development. Additionally, passive stretching of spastic muscle reduces spasticity and facilitates the motor function
Intervention Type
Other
Intervention Name(s)
Task training
Intervention Description
In group B (task training) will be applied for 60 minutes per day, 3 times per week for 3 months the individual session lasted roughly 10 minutes for each activity. Standing from a seated situation; (ii) reaching for an object high up, which required ankle plantarflexion from the standing position, and go back to the starting position with the heel leaning on the floor; (iii) stepping on and off a bench; (iv) walking up and downstairs. (10) (v) Drinking water hold the cup stable and drink it by lifting it at an appropriate speed and power (vi) Moving a rubber ball, the task involved taking a 6.5 cm diameter rubber ball and placing it in a basket with a diameter of ten cm (the basket location was moved in various directions).
Primary Outcome Measure Information:
Title
Gross Motor Function Measure (GMFM-88)
Description
The Gross Motor Function Measure (GMFM) is an observational clinical tool designed to evaluate change in gross motor function in children with cerebral palsy. The GMFM-88 item scores can be summed to calculate raw and percent scores for each of the five GMFM dimensions of interest selected goal areas and total GMFM-88 scores. The scoring system of the GMFM is a four-point scale divided into five categories (lying and rolling; sitting; crawling and kneeling; standing; walking, running) Reliability refers to dependability, consistency, and stability of scores on an assessment tool. Both versions of GMFM were shown to be highly reliable, with ICCs of greater than .98 (95% confidence interval=0.965-0.994) and both of them can be used in clinical practice or research.
Time Frame
Base line and after 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female patient Age 3- 10 years. Diagnosed with CP by a specialist. Children with CP GMFCS level I-II. Types of Cerebral palsy (spastic diplegic, quadriplegic, hemiplegic,) without severe abnormalities Cognitive ability should be sufficient that he/she follow simple verbal commands and instructions during training Exclusion Criteria: Patient with fixed contracture Patient receiving treatment that affects motor function such as botulinum injection and orthopedic surgery -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tehreem Mukhtar, MS
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allied Hospital Faisalabad
City
Faisalabad
State/Province
Pakistan(Punjab_
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Bobath Technique Versus Task Oriented Training on Gross Motor Function in Cerebral Palsy Children

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