Spastic Cerebral PalsyNCT04925102
Prediction of Recovery in Spastic Cerebral Palsy.
An observational study of Spastic Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
Until now, for children with cerebral palsy (CP) , diagnostic and some prognostic predictive machine learning studies have been conducted, but prognostic studies targeted specific milestone according to specific gross motor function measure (GMFCS) levels; such as walking and running predictors at GMFCS II and III and… Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Spastic Cerebral Palsy
- What is being tested?
- Standardized treatment protocol for cerebral palsy
- Type of treatment
- Injection or infusion
- How many people
- 125 participants
- Where
- 1 sitePakistan
- Study dates
- 14 Jun 2021to 30 Apr 2022
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Spastic cerebral palsy children
Who may be able to join
- Cerebral palsy children with positive score 1 on items 3 and 4 of Hypertonia Assessment Tool (HAT).
- Spastic cerebral palsy children with any functional ability level(Gross Motor Function Classification System (GMFCS) levels I-V)
Who cannot join
- Children of any other type of cerebral palsy
- Not willing to participate
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Helping Hand Institute of Rehabilitation Sciences
Mansehra, Khyber Pakhtunkhwa, 21310
Keramat Ullah, 0992371001, karamatjee@yahoo.com
About this study
Until now, for children with cerebral palsy (CP) , diagnostic and some prognostic predictive machine learning studies have been conducted, but prognostic studies targeted specific milestone according to specific gross motor function measure (GMFCS) levels; such as walking and running predictors at GMFCS II and III and GMFCS II respectively, and not covered specific types of cerebral palsy. Predictions studies were limited by the lack of specificity of child and family characteristics was not taken into the account prospectively.
It is therefore the utmost need to support clinical decision making by predicting the recovery in spastic cerebral palsy. Recovery predictive factors can play an important role for this purpose. Thus, this study aims to predict the recovery in spastic cerebral palsy according to all GMFCS level by means of a prediction index/model.
Read the detailed description
Spasticity is often considered as the main cause of functional limitation in cerebral palsy (CP) children. The main feature of cerebral palsy is the impaired development of gross motor functions in children. Gross motor functions are considered as an indicator of the overall prognosis of cerebral palsy as these are closely associated with other impairments in the cerebral palsy child such as auditory, cognitive or visual impairments. The gross motor function measure (GMFM) tool is most widely used to assess motor function, severity and treatment response of children with cerebral palsy. The five levels of GMFCS have been widely employed in cerebral palsy children less than 12 years of age with the focus on sitting and walking abilities of the child. Literature confirmed the importance of addressing the gross and fine motor skills in cerebral palsy children. Childhood factors that predict the participation of young adults with cerebral palsy in domestic life include; intellectual disability, low manual ability, limited motor capacity and epilepsy. Moreover, CP child primary and secondary impairments, co-morbidities, their adaptive behaviour, family, rehabilitation services all are determinants of changes in the gross motor ability of the child and their participation in daily routine activities. Thus, all these determinants need to be considered while planning the intervention for a cerebral palsy child and at the time outcome evaluation as well. Good prognostic predictors for ambulation in cerebral palsy children were identified through meta-analysis of observational studies which includes; independent sitting at 2 years of age, epilepsy, absence of intellectual disability and visual impairment. Machine learning (ML) approaches have been increasingly used in cerebral palsy research. Jing Zhang et al identified GMFCS and intellectual capacity as associated factors of self-care activity development, it was also mentioned that GMFCS has a role in mobility activities development. A predictive machine learning model was developed to highlight the factors associated with intellectual disability in the cerebral palsy population of the teenager, with the sensitivity, specificity and average accuracy of 78%. The result of this model confirmed the significant association of gross motor function, poor manual abilities and epilepsy with profound intellectual disability.
- Conditions
- Spastic Cerebral Palsy
- Being tested
- Standardized treatment protocol for cerebral palsy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized treatment protocol for cerebral palsyOther
Passive and active range of motion (ROM) exercises of all joints, prone positioning, slow prolonged manual stretching (30 minutes daily), standing frame for children with GMFCS IV-V, supported sitting, supported walking, lower limb serial casting (if needed), active strength training, progressive resistance training, functional exercises, sensory integration: therapeutic activities to organize sensation from the body and environment, bimanual training: repetitive task training in the use of two hands together, context-focused therapy: changing the task or the environment, the occupational therapy, cognitive behaviour therapy and home programmes.
| Study group | Role | What they receive |
|---|---|---|
| GMFCS level I | Goal specific treatment protocol with respect to the problem enlisted in gross motor function measure (GMFCS) level I will be provided to the spastic cerebral palsy children in the sets of 15-30 repetitions. The protocol will be performed in 30-40 minute sessions thrice a week. Receives: Other: Standardized treatment protocol for cerebral palsy | |
| GMFCS level II | Goal specific treatment protocol with respect to the problem enlisted in gross motor function measure (GMFCS) level II will be provided to the spastic cerebral palsy children in the sets of 15-30 repetitions. The protocol will be performed in 30-40 minute sessions thrice a week. Receives: Other: Standardized treatment protocol for cerebral palsy | |
| GMFCS level III | Goal specific treatment protocol with respect to the problem enlisted in GMFCS level III will be provided to the spastic cerebral palsy children in the sets of 15-30 repetitions. The protocol will be performed in 30-40 minute sessions thrice a week. Receives: Other: Standardized treatment protocol for cerebral palsy | |
| GMFCS level IV | Goal specific treatment protocol with respect to the problem enlisted in gross motor function measure (GMFCS) level IV will be provided to the spastic cerebral palsy children in the sets of 15-30 repetitions. The protocol will be performed in 30-40 minute sessions thrice a week. Receives: Other: Standardized treatment protocol for cerebral palsy | |
| GMFCS level V | Goal specific treatment protocol with respect to the problem enlisted in gross motor function measure (GMFCS) level V will be provided to the spastic cerebral palsy children in the sets of 15-30 repetitions. The protocol will be performed in 30-40 minute sessions thrice a week. Receives: Other: Standardized treatment protocol for cerebral palsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross motor function measure
The Gross Motor Function Measure (GMFM) is used to assess change in gross motor function in children with cerebral palsy aged 5 months to 16 years of age. The original GMFM version has 88 items each scored on a 4-point ordinal scale of 0 to 3, where 0 indicates that the child does not initiate the task; 1 indicates that the child initiates the task (completes < 10% of the activity); 2 indicates that the child partially completes the task (completes from 10 to 99% of the activity), and 3 indicates that the child completes the task (100%). Up to 12 weeks
Measured: 12 Weeks
Modified Ashworth scale
Modified Ashworth scale (MAS) is used for the assessment of spasticity. Muscle tone is quantified in MAS by the assessment of the resistance of the spastic muscles. It is similar to Ashworth but adds a 1+ scoring category to indicate resistance through less than half of the movement. Score range from 0-4, with 6 choices. 0 indicates, no increase in the muscle tone and 4 indicates rigidity of the affected part. Up to 12 weeks
Measured: 12 weeks
Functional Independence Measure for Children
Functional Independence Measure (FIM) is an 18-item, 7-level ordinal scale instrument that measures a child's consistent performance in essential daily functional skills. FIM is categorized into 2 main functional streams: "Dependent" (i.e; requires helper: scores 1-5) and "Independent" (i.e; requires no helper: scores 6-7). Scores 1 (total assistance) and 2 (maximal assistance) belonged to the "Complete Dependence" category. Scores 3 (moderate assistance), 4 (minimal contact assistance), and 5 (supervision or set-up) belonged to the "Modified Dependence" category. Scores 6 (modified independence) and 7 (complete independence) belonged to the "Independent" category. Up to 12 weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start14 Jun 2021
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Spastic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Collaborators
- Helping Hand Institute of Rehabilitation Sciences
- Responsible party
- Sponsor
- Investigators
- Imran Amjad, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04925102
- Sponsor's protocol ID
- REC/0882 Anam Habib
- Status last verified
- Feb 2022
- First submitted
- 19 May 2021
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wagenaar N, Verhage CH, de Vries LS, van Gasselt BPL, Koopman C, Leemans A, Groenendaal F, Benders MJNL, van der Aa NE. Early prediction of unilateral cerebral palsy in infants at risk: MRI versus the hand assessment for infants. Pediatr Res. 2020 Apr;87(5):932-939. doi: 10.1038/s41390-019-0664-5. Epub 2019 Nov 13.
PubMed 31722367Schertz M, Shiran SI, Myers V, Weinstein M, Fattal-Valevski A, Artzi M, Ben Bashat D, Gordon AM, Green D. Imaging Predictors of Improvement From a Motor Learning-Based Intervention for Children With Unilateral Cerebral Palsy. Neurorehabil Neural Repair. 2016 Aug;30(7):647-60. doi: 10.1177/1545968315613446. Epub 2015 Nov 11.
PubMed 26564999Begnoche DM, Chiarello LA, Palisano RJ, Gracely EJ, McCoy SW, Orlin MN. Predictors of Independent Walking in Young Children With Cerebral Palsy. Phys Ther. 2016 Feb;96(2):183-92. doi: 10.2522/ptj.20140315. Epub 2015 Jun 18.
PubMed 26089044Bohm H, Wanner P, Rethwilm R, Doderlein L. Prevalence and predictors for the ability to run in children and adolescents with cerebral palsy. Clin Biomech (Bristol). 2018 Oct;58:103-108. doi: 10.1016/j.clinbiomech.2018.07.014. Epub 2018 Jul 27.
PubMed 30071441
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Recovery in Spastic Cerebral Palsy.
- ClinicalTrials.gov ID
- NCT04925102
- Acronym / sponsor ID
- REC/0882 Anam Habib
- Conditions
- Spastic Cerebral Palsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Collaborators
- Helping Hand Institute of Rehabilitation Sciences
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 14 Jun 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.
Until now, for children with cerebral palsy (CP) , diagnostic and some prognostic predictive machine learning studies have been conducted, but prognostic studies targeted specific milestone according to specific gross motor function measure (GMFCS) levels; such as walking and running predictors at GMFCS II and III and GMFCS II respectively, and not covered specific types of cerebral palsy. Predictions studies were limited by the lack of specificity of child and family characteristics was not taken into the account prospectively.
It is therefore the utmost need to support clinical decision making by predicting the recovery in spastic cerebral palsy. Recovery predictive factors can play an important role for this purpose. Thus, this study aims to predict the recovery in spastic cerebral palsy according to all GMFCS level by means of a prediction index/model.
Detailed description
Spasticity is often considered as the main cause of functional limitation in cerebral palsy (CP) children. The main feature of cerebral palsy is the impaired development of gross motor functions in children. Gross motor functions are considered as an indicator of the overall prognosis of cerebral palsy as these are closely associated with other impairments in the cerebral palsy child such as auditory, cognitive or visual impairments. The gross motor function measure (GMFM) tool is most widely used to assess motor function, severity and treatment response of children with cerebral palsy. The five levels of GMFCS have been widely employed in cerebral palsy children less than 12 years of age with the focus on sitting and walking abilities of the child. Literature confirmed the importance of addressing the gross and fine motor skills in cerebral palsy children. Childhood factors that predict the participation of young adults with cerebral palsy in domestic life include; intellectual disability, low manual ability, limited motor capacity and epilepsy. Moreover, CP child primary and secondary impairments, co-morbidities, their adaptive behaviour, family, rehabilitation services all are determinants of changes in the gross motor ability of the child and their participation in daily routine activities. Thus, all these determinants need to be considered while planning the intervention for a cerebral palsy child and at the time outcome evaluation as well. Good prognostic predictors for ambulation in cerebral palsy children were identified through meta-analysis of observational studies which includes; independent sitting at 2 years of age, epilepsy, absence of intellectual disability and visual impairment. Machine learning (ML) approaches have been increasingly used in cerebral palsy research. Jing Zhang et al identified GMFCS and intellectual capacity as associated factors of self-care activity development, it was also mentioned that GMFCS has a role in mobility activities development. A predictive machine learning model was developed to highlight the factors associated with intellectual disability in the cerebral palsy population of the teenager, with the sensitivity, specificity and average accuracy of 78%. The result of this model confirmed the significant association of gross motor function, poor manual abilities and epilepsy with profound intellectual disability.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| GMFCS level I | – | Other: Standardized treatment protocol for cerebral palsyGoal specific treatment protocol with respect to the problem enlisted in gross motor function measure (GMFCS) level I will be provided to the spastic cerebral palsy children in the sets of 15-30 repetitions. The protocol will be performed in 30-40 minute sessions thrice a week. |
| GMFCS level II | – | Other: Standardized treatment protocol for cerebral palsyGoal specific treatment protocol with respect to the problem enlisted in gross motor function measure (GMFCS) level II will be provided to the spastic cerebral palsy children in the sets of 15-30 repetitions. The protocol will be performed in 30-40 minute sessions thrice a week. |
| GMFCS level III | – | Other: Standardized treatment protocol for cerebral palsyGoal specific treatment protocol with respect to the problem enlisted in GMFCS level III will be provided to the spastic cerebral palsy children in the sets of 15-30 repetitions. The protocol will be performed in 30-40 minute sessions thrice a week. |
| GMFCS level IV | – | Other: Standardized treatment protocol for cerebral palsyGoal specific treatment protocol with respect to the problem enlisted in gross motor function measure (GMFCS) level IV will be provided to the spastic cerebral palsy children in the sets of 15-30 repetitions. The protocol will be performed in 30-40 minute sessions thrice a week. |
| GMFCS level V | – | Other: Standardized treatment protocol for cerebral palsyGoal specific treatment protocol with respect to the problem enlisted in gross motor function measure (GMFCS) level V will be provided to the spastic cerebral palsy children in the sets of 15-30 repetitions. The protocol will be performed in 30-40 minute sessions thrice a week. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Spastic cerebral palsy children
Key inclusion criteria (2 listed)
- Cerebral palsy children with positive score 1 on items 3 and 4 of Hypertonia Assessment Tool (HAT).
- Spastic cerebral palsy children with any functional ability level(Gross Motor Function Classification System (GMFCS) levels I-V)
Key exclusion criteria (2 listed)
- Children of any other type of cerebral palsy
- Not willing to participate
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 |
|---|---|---|
| Standardized treatment protocol for cerebral palsyPassive and active range of motion (ROM) exercises of all joints, prone positioning, slow prolonged manual stretching (30 minutes daily), standing frame for children with GMFCS IV-V, supported sitting, supported walking, lower limb serial casting (if needed), active strength training, progressive resistance training, functional exercises, sensory integration: therapeutic activities to organize sensation from the body and environment, bimanual training: repetitive task training in the use of two hands together, context-focused therapy: changing the task or the environment, the occupational therapy, cognitive behaviour therapy and home programmes. | Other | GMFCS level I, GMFCS level II, GMFCS level III, GMFCS level IV, GMFCS level V |
Primary outcome
Gross motor function measure
Time frame: 12 Weeks
The Gross Motor Function Measure (GMFM) is used to assess change in gross motor function in children with cerebral palsy aged 5 months to 16 years of age. The original GMFM version has 88 items each scored on a 4-point ordinal scale of 0 to 3, where 0 indicates that the child does not initiate the task; 1 indicates that the child initiates the task (completes < 10% of the activity); 2 indicates that the child partially completes the task (completes from 10 to 99% of the activity), and 3 indicates that the child completes the task (100%). Up to 12 weeks
Modified Ashworth scale
Time frame: 12 weeks
Modified Ashworth scale (MAS) is used for the assessment of spasticity. Muscle tone is quantified in MAS by the assessment of the resistance of the spastic muscles. It is similar to Ashworth but adds a 1+ scoring category to indicate resistance through less than half of the movement. Score range from 0-4, with 6 choices. 0 indicates, no increase in the muscle tone and 4 indicates rigidity of the affected part. Up to 12 weeks
Functional Independence Measure for Children
Time frame: 12 weeks
Functional Independence Measure (FIM) is an 18-item, 7-level ordinal scale instrument that measures a child's consistent performance in essential daily functional skills. FIM is categorized into 2 main functional streams: "Dependent" (i.e; requires helper: scores 1-5) and "Independent" (i.e; requires no helper: scores 6-7). Scores 1 (total assistance) and 2 (maximal assistance) belonged to the "Complete Dependence" category. Scores 3 (moderate assistance), 4 (minimal contact assistance), and 5 (supervision or set-up) belonged to the "Modified Dependence" category. Scores 6 (modified independence) and 7 (complete independence) belonged to the "Independent" category. Up to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
- Background: PubMed 31722367Wagenaar N, Verhage CH, de Vries LS, van Gasselt BPL, Koopman C, Leemans A, Groenendaal F, Benders MJNL, van der Aa NE. Early prediction of unilateral cerebral palsy in infants at risk: MRI versus the hand assessment for infants. Pediatr Res. 2020 Apr;87(5):932-939. doi: 10.1038/s41390-019-0664-5. Epub 2019 Nov 13.
- Background: PubMed 26564999Schertz M, Shiran SI, Myers V, Weinstein M, Fattal-Valevski A, Artzi M, Ben Bashat D, Gordon AM, Green D. Imaging Predictors of Improvement From a Motor Learning-Based Intervention for Children With Unilateral Cerebral Palsy. Neurorehabil Neural Repair. 2016 Aug;30(7):647-60. doi: 10.1177/1545968315613446. Epub 2015 Nov 11.
- Background: PubMed 26089044Begnoche DM, Chiarello LA, Palisano RJ, Gracely EJ, McCoy SW, Orlin MN. Predictors of Independent Walking in Young Children With Cerebral Palsy. Phys Ther. 2016 Feb;96(2):183-92. doi: 10.2522/ptj.20140315. Epub 2015 Jun 18.
- Background: PubMed 30071441Bohm H, Wanner P, Rethwilm R, Doderlein L. Prevalence and predictors for the ability to run in children and adolescents with cerebral palsy. Clin Biomech (Bristol). 2018 Oct;58:103-108. doi: 10.1016/j.clinbiomech.2018.07.014. Epub 2018 Jul 27.
- 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.
Imran Amjad, PhD 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?
An observational study of Spastic 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 2 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: status not confirmed, as of the sponsor's last update on 7 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, PhD ((+92)3324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gross motor function measure (time frame: 12 Weeks). 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?
On the ClinicalTrials.gov record for NCT04925102, which also lists 4 linked publications.
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 7 Feb 2022.