Spastic Cerebral Palsy Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 125 |
Est. completion date | April 30, 2022 |
Est. primary completion date | April 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 12 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Pakistan | Helping Hand Institute of Rehabilitation Sciences | Mansehra | Khyber Pakhtunkhwa |
Lead Sponsor | Collaborator |
---|---|
Riphah International University | Helping Hand Institute of Rehabilitation Sciences |
Pakistan,
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. — View Citation
Böhm H, Wanner P, Rethwilm R, Döderlein 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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 12 Weeks | |
Primary | 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 | 12 weeks | |
Primary | 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 | 12 weeks |
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