Cerebral PalsyNCT05981287
Comparison of Task-oriented Activity Based Neurodevelopmental Principles and Gross Motor Task Training.
A study testing Task-oriented activities based on NDT (TOA-NDT) principle and Conventional Physical Therapy and Gross motor task training and Conventional physical therapy (CPT) in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study aims to find the comparison of task oriented activity based neurodevelopmental principles and gross motor task training on balance, trunk control and functional mobility in children with cerebral palsy. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Task-oriented activities based on NDT (TOA-NDT) principle and Conventional Physical Therapy and Gross motor task training and Conventional physical therapy (CPT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Sep 2022to 5 Apr 2023
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with spastic cerebral palsy
- Both boys and girls
- Age 5 - 12 years old
- Able to follow verbal commands
- Having level I or II of GMFCS
Who cannot join
- Uncooperative
- On antiepileptic and anti-spastic medications
- Having visual or intellectual impairments
- Having hearing deficit
- With any cardiac anomalies affecting exercise tolerance
- Less than 6-month post-orthopedic surgery or post-botulinum toxin injections
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Task-oriented Activity Based Neurodevelopmental Principles and Gross Motor Task Training on Balance, Trunk Control and Functional Mobility in Children With Cerebral Palsy.
This study aims to find the comparison of task oriented activity based neurodevelopmental principles and gross motor task training on balance, trunk control and functional mobility in children with cerebral palsy.
Read the detailed description
Cerebral palsy (CP) being a non-progressive neurodevelopmental condition, is the leading cause of chronic disability in children, making them physically and mentally handicapped and socially unapproachable. The low tone of the torso also causes postural instability, lack of mobility, and muscle stiffness in the legs. Therapeutic intervention for children with cerebral palsy should be composed of goal directed, functional, and meaningful activities by considering the clinical type, degree of disability, cognitive level and interest of the child. The trunk being the central key point of the body, proximal trunk control is a prerequisite for distal limb movement control, balance, and functional mobility. Since children with cerebral palsy show damage not only in the function and an ability to accomplish tasks, but also in the quality of movement. The objective of this study will be to help clinicians regarding the effectiveness of task-oriented training and gross motor functional training for children with cerebral palsy.
This will be a Randomized Clinical Trial in which participants of age 5 - 12 years with cerebral palsy will be assigned randomly for the study. Population will be taken from Physical Therapy Department of Agile Rehabilitation Complex, Bahawalpur. After taking consent, demographics including age, gender and birth history etc. will be recorded. Questionnaires will be distributed among parents and their responses will be collected. Questionnaires for trunk impairment scale, postural assessment scale, pediatric balance scale and GMFM-88 will be used as tools of assessment. The collected data will be analyzed in Statistical Package for the Social Sciences (SPSS) 27.0.
- Conditions
- Cerebral Palsy
- Being tested
- Task-oriented activities based on NDT (TOA-NDT) principle and Conventional Physical Therapy, Gross motor task training and Conventional physical therapy (CPT)
- Keywords
- Balance
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task-oriented activities based on NDT (TOA-NDT) principle and Conventional Physical TherapyOther
Also called Comparison between task oriented activities and gross motor task training
This will be a randomized clinical trial. patients are divided into two groups. one of them will undergo task-oriented activities along with conventional physical therapy treatment, while the other will undergo gross motor task training along with conventional physical therapy treatment. Purpose is to determine that which of them has greater benefit in improving balance trunk control and functional mobility in children with cerebral palsy.
Gross motor task training and Conventional physical therapy (CPT)Other
Also called Comparison between task oriented activities and gross motor task training
This will be a randomized clinical trial. patients are divided into two groups. one of them will undergo task-oriented activities along with conventional physical therapy treatment, while the other will undergo gross motor task training along with conventional physical therapy treatment. Purpose is to determine that which of them has greater benefit in improving balance trunk control and functional mobility in children with cerebral palsy.
| Study group | Role | What they receive |
|---|---|---|
| Task-oriented activities based on NDT (TOA-NDT) principle and Conventional Physical Therapy | Experimental | The experimental group undergo conventional physical therapy and additional task-oriented activities based on NDT (TOT-NDT) principle 10 - 36 sessions in 5-8 weeks, 2 to 6 days per sessions. Receives: Other: Task-oriented activities based on NDT (TOA-NDT) principle and Conventional Physical Therapy |
| Gross motor task training and Conventional physical therapy (CPT) | Active comparator | This group will receive conventional physical therapy and additional gross motor task training 10-36 sessions in 5-8 weeks, 2 to 6 days per sessions. Receives: Other: Gross motor task training and Conventional physical therapy (CPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Balance Scale - PBS
Pediatric balance scale is an outcome measurement tool used to assess functional balance skills in children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.
Measured: 2 months
Trunk Control Measurement Scale - TCMS
Trunk Control Measurement Scale is the clinical tool to measure trunk control in children with cerebral palsy. Control of muscles is necessary to maintain stability around the trunk.
Measured: 2 months
Gross Motor Function Measure 88 - 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. There are two versions of the GMFM - the original 88-item measure (GMFM-88) and the more recent 66-item GMFM (GMFM-66). The scoring system of the GMFM is a four-point scale that consists of 66 items divided into five dimensions of gross motor function:(a) lying and rolling, (b) sitting, (c) crawling and kneeling, (d) standing, and (e) walking, running and jumping.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start15 Sep 2022
- Primary completion5 Mar 2023
- Study completion5 Apr 2023
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnab Altaf, Mphill, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05981287
- Sponsor's protocol ID
- REC/RCR & AHS/22/0720
- Status last verified
- Jul 2023
- First submitted
- 4 Jan 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Task-oriented Activity Based Neurodevelopmental Principles and Gross Motor Task Training on Balance, Trunk Control and Functional Mobility in Children With Cerebral Palsy.
- ClinicalTrials.gov ID
- NCT05981287
- Acronym / sponsor ID
- REC/RCR & AHS/22/0720
- Conditions
- Cerebral Palsy
- Keywords
- Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 5 Mar 2023 (actual)
- Study completion
- 5 Apr 2023 (actual)
- First posted
- 8 Aug 2023 (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.
This study aims to find the comparison of task oriented activity based neurodevelopmental principles and gross motor task training on balance, trunk control and functional mobility in children with cerebral palsy.
Detailed description
Cerebral palsy (CP) being a non-progressive neurodevelopmental condition, is the leading cause of chronic disability in children, making them physically and mentally handicapped and socially unapproachable. The low tone of the torso also causes postural instability, lack of mobility, and muscle stiffness in the legs. Therapeutic intervention for children with cerebral palsy should be composed of goal directed, functional, and meaningful activities by considering the clinical type, degree of disability, cognitive level and interest of the child. The trunk being the central key point of the body, proximal trunk control is a prerequisite for distal limb movement control, balance, and functional mobility. Since children with cerebral palsy show damage not only in the function and an ability to accomplish tasks, but also in the quality of movement. The objective of this study will be to help clinicians regarding the effectiveness of task-oriented training and gross motor functional training for children with cerebral palsy.
This will be a Randomized Clinical Trial in which participants of age 5 - 12 years with cerebral palsy will be assigned randomly for the study. Population will be taken from Physical Therapy Department of Agile Rehabilitation Complex, Bahawalpur. After taking consent, demographics including age, gender and birth history etc. will be recorded. Questionnaires will be distributed among parents and their responses will be collected. Questionnaires for trunk impairment scale, postural assessment scale, pediatric balance scale and GMFM-88 will be used as tools of assessment. The collected data will be analyzed in Statistical Package for the Social Sciences (SPSS) 27.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Task-oriented activities based on NDT (TOA-NDT) principle and Conventional Physical Therapy | Experimental | Other: Task-oriented activities based on NDT (TOA-NDT) principle and Conventional Physical TherapyThe experimental group undergo conventional physical therapy and additional task-oriented activities based on NDT (TOT-NDT) principle 10 - 36 sessions in 5-8 weeks, 2 to 6 days per sessions. |
| Gross motor task training and Conventional physical therapy (CPT) | Active comparator | Other: Gross motor task training and Conventional physical therapy (CPT)This group will receive conventional physical therapy and additional gross motor task training 10-36 sessions in 5-8 weeks, 2 to 6 days per sessions. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children with spastic cerebral palsy
- Both boys and girls
- Age 5 - 12 years old
- Able to follow verbal commands
- Having level I or II of GMFCS
Key exclusion criteria (6 listed)
- Uncooperative
- On antiepileptic and anti-spastic medications
- Having visual or intellectual impairments
- Having hearing deficit
- With any cardiac anomalies affecting exercise tolerance
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 |
|---|---|---|
| Task-oriented activities based on NDT (TOA-NDT) principle and Conventional Physical TherapyAlso: Comparison between task oriented activities and gross motor task trainingThis will be a randomized clinical trial. patients are divided into two groups. one of them will undergo task-oriented activities along with conventional physical therapy treatment, while the other will undergo gross motor task training along with conventional physical therapy treatment. Purpose is to determine that which of them has greater benefit in improving balance trunk control and functional mobility in children with cerebral palsy. | Other | Task-oriented activities based on NDT (TOA-NDT) principle and Conventional Physical Therapy |
| Gross motor task training and Conventional physical therapy (CPT)Also: Comparison between task oriented activities and gross motor task trainingThis will be a randomized clinical trial. patients are divided into two groups. one of them will undergo task-oriented activities along with conventional physical therapy treatment, while the other will undergo gross motor task training along with conventional physical therapy treatment. Purpose is to determine that which of them has greater benefit in improving balance trunk control and functional mobility in children with cerebral palsy. | Other | Gross motor task training and Conventional physical therapy (CPT) |
Primary outcome
Pediatric Balance Scale - PBS
Time frame: 2 months
Pediatric balance scale is an outcome measurement tool used to assess functional balance skills in children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.
Trunk Control Measurement Scale - TCMS
Time frame: 2 months
Trunk Control Measurement Scale is the clinical tool to measure trunk control in children with cerebral palsy. Control of muscles is necessary to maintain stability around the trunk.
Gross Motor Function Measure 88 - GMFM 88
Time frame: 2 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. There are two versions of the GMFM - the original 88-item measure (GMFM-88) and the more recent 66-item GMFM (GMFM-66). The scoring system of the GMFM is a four-point scale that consists of 66 items divided into five dimensions of gross motor function:(a) lying and rolling, (b) sitting, (c) crawling and kneeling, (d) standing, and (e) walking, running and jumping.
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 8 Aug 2023.
- 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.
Arnab Altaf, Mphill 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 Task-oriented activities based on NDT (TOA-NDT) principle and Conventional Physical Therapy and Gross motor task training and Conventional physical therapy (CPT) 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 5 inclusion and 6 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 8 Aug 2023. 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?
Pediatric Balance Scale - PBS (time frame: 2 months). The study lists 3 primary outcomes in all. 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 8 Aug 2023.