Cerebral PalsyNCT05123937
Effects of Bobath Technique Versus Task Oriented Training on Gross Motor Function in Cerebral Palsy Children
A study testing BOBATH technique and Task training in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- BOBATH technique and Task training
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Mar 2021to 30 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Patient with fixed contracture Patient receiving treatment that affects motor function such as botulinum injection and orthopedic surgery
- -
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Allied Hospital Faisalabad
Faisalabad, Pakistan(Punjab_, 54000
About this study
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.
- Conditions
- Cerebral Palsy
- Being tested
- BOBATH technique, Task training
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOBATH techniqueOther
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
Task trainingOther
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).
| Study group | Role | What they receive |
|---|---|---|
| BOBATH technique | Experimental | 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 Receives: Other: BOBATH technique |
| Task training | Experimental | 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). Receives: Other: Task training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Base line and after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start15 Mar 2021
- Primary completion15 Dec 2021
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- 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.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tehreem Mukhtar, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05123937
- Sponsor's protocol ID
- REC/LhR/21/0233 Amal Fatima
- Status last verified
- Apr 2022
- First submitted
- 5 Nov 2021
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Bobath Technique Versus Task Oriented Training on Gross Motor Function in Cerebral Palsy Children
- ClinicalTrials.gov ID
- NCT05123937
- Acronym / sponsor ID
- REC/LhR/21/0233 Amal Fatima
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 17 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BOBATH technique | Experimental | Other: BOBATH techniqueIn 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 |
| Task training | Experimental | Other: Task trainingIn 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). |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- Patient with fixed contracture Patient receiving treatment that affects motor function such as botulinum injection and orthopedic surgery
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BOBATH techniqueIn 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 | Other | BOBATH technique |
| Task trainingIn 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). | Other | Task training |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tehreem Mukhtar, MS principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BOBATH technique and Task training in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gross Motor Function Measure (GMFM-88) (time frame: Base line and after 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2022.