Brief 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 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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

125

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

11 months study duration

First Submitted

Initial submission to the registry

May 19, 2021

Completed

26 days until next milestone

First Posted

Study publicly available on registry

June 14, 2021

Completed

Same day until next milestone

Study Start

First participant enrolled

June 14, 2021

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed

Last Updated

February 7, 2022

Status Verified

February 1, 2022

Enrollment Period

11 months

First QC Date

May 19, 2021

Last Update Submit

February 4, 2022

Conditions

Spastic Cerebral Palsy

Outcome Measures

Primary Outcomes (3)

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
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
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

Study Arms (5)

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.