- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05123937
Effects of Bobath Technique Versus Task Oriented Training on Gross Motor Function in Cerebral Palsy Children
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pakistan(Punjab_
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Faisalabad, Pakistan(Punjab_, Pakistan, 54000
- Allied Hospital Faisalabad
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: BOBATH technique
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
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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
|
|
Experimental: Task training
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).
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gross Motor Function Measure (GMFM-88)
Time Frame: Base line and after 3 months
|
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.
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Base line and after 3 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/LhR/21/0233 Amal Fatima
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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