- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04925102
Prediction of Recovery in Spastic Cerebral Palsy.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Imran Amjad, PhD
- Phone Number: (+92)3324390125
- Email: imran.amjad@riphah.edu.pk
Study Locations
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Khyber Pakhtunkhwa
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Mansehra, Khyber Pakhtunkhwa, Pakistan, 21310
- Recruiting
- Helping Hand Institute Of rehabilitation sciences
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Contact:
- Keramat Ullah
- Phone Number: 0992371001
- Email: karamatjee@yahoo.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Children of any other type of cerebral palsy
- Not willing to participate
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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12 Weeks
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Modified Ashworth scale
Time Frame: 12 weeks
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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
|
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
|
12 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General 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.
- Schertz 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.
- Begnoche 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.
- Bohm 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, Avon). 2018 Oct;58:103-108. doi: 10.1016/j.clinbiomech.2018.07.014. Epub 2018 Jul 27.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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/0882 Anam Habib
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
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