Physical Therapy for Improving Functionality, Gait and Participation in Cerebral Palsy — FIMAPACE  

Cerebral Palsy Clinical Trial

Official title: Effectiveness of Physical Therapy for Improving the Functionality, Gait and Participation in the Environment in Children and Adolescents With Cerebral Palsy: Randomized Clinical Trial

Status Recruiting

Clinical Trial Summary

Cerebral Palsy is a non-progressive nature lesion of the Central Nervous System, with a wide spectrum of impairments at body structure and function, which has a great impact at activity and participation in the environment. The intensity of participation is influenced by multiple factors, among which independent mobility stands out, through the functional activity of walking. Children and adolescents with Cerebral Palsy present limitations in gait function both at the level of body structure and activity and improving these aspects is one of the main therapeutic objectives in their treatment.

Physical Therapy interventions based on task learning and achieving objectives have proven to be effective in improving functional skills, gait and participation.

Due to COVID-19, interventions have been interrupted or reduced in periodicity. For this reason, it is essential to provide alternatives to Physical Therapy interventions for children and adolescents with Cerebral Palsy. Telehealth may play an important role both in maintaining function and in monitoring individuals, in addition to bringing the Physical Therapist closer to the natural environment of the child / adolescent through digital platforms.

Therefore the aim of this clinical trial is to verify that a Physiotherapy intervention that combines face-to-face sessions with telecare in natural settings is effective in improving the functional activity of walking and participation in the environment of children and adolescents with Cerebral Palsy.

The study population are children and adolescents diagnosed with Cerebral Palsy; ages 6-17 years old. The sample of 50 subjects (25 in each group) will be recruited in care centers for children and adolescents with Cerebral Palsy in Alcalá de Henares.

The outcome variables are: participation in the environment (Spanish version of the Children's Assessment of Participation and Enjoyment - CAPE), gait speed (10-meter walk test

• 10MM), gait endurance (6-minute walk test - 6MM), gross motor function (Spanish version of the Gross Motor Function Measure - GMFM-SP) and static and dynamic balance (Spanish version of the Pediatric Balance Scale - PBS). They will be collected in three moments: baseline assessment (V0); intermediate assessment (V1) at 6 weeks at the end of each group intervention; Final assessment (V2) 3 months after baseline.

Clinical Trial Description

Group A Physical Therapy intervention group will receive 18 sessions, 3 times a week, for 6 consecutive weeks; on the one hand, 12 face-to-face sessions of approximately 90 minutes duration, in which the Physical Therapy treatment will be carried out based on training of specific tasks directed to objectives and training of gait with a treadmill; In addition, a therapeutic education program will be carried out, with 6 telehealth sessions, which will include action observation therapy. Subjects in Group B (control group) will receive their usual Physiotherapy intervention regimen for 6 weeks at their referral center and the same telehealth Therapeutic Education program of the intervention group. The face-to-face sessions of the intervention group will be carried out in the Physiotherapy Teaching Unit of the University of Alcalá, and the telehealth sessions of the Therapeutic Education program of both groups will be carried out by remote assistance through a digital platform. All will be carried out by specialist Physiotherapists, members of the research team.

Statistical Analysis: After assessments, the data will be analyzed to verify the results. It will be done: descriptive analysis of the sample (means, medians, standard deviations and quartiles; normality test; frequency distributions): homogeneity check of the groups (t-Student or Mann Withney's U - quantitative variables; Chi square or F of Fisher - categorical variables); effectiveness analysis (parametric tests or not of paired samples; multivariate models to adjust for possible confounding factors; multivariate model of repeated measures to evaluate the result of the intervention. The statistical package Statistical Package for the Social Sciences software (25 version , SPSS Inc, Chicago, USA) or the statistical package STATA MP v14.2 (StataCo) ;

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis
• Physical Therapy
• Telehealth
• Therapeutic Education

• NCT number: NCT04778930
• Study type: Interventional
• Source: University of Alcala
• Contact: Soraya Pacheco da Costa, PhD
• Phone: 661855923
• Email: soraya.pacheco@uah.es
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Completion date: December 31, 2023