Intensive Goal Training With Educational Strategies for Adolescents With Cerebral Palsy

NCT ID: NCT05635565

Last Updated: 2022-12-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-31
• Study Completion Date: 2024-07-31

Brief Summary

Adolescents with cerebral palsy (CP) have limitations to perform daily routine activities. The use of educational strategies associated to an approach based on motor learning principles was found to be effective in promoting motor outcomes in individuals with CP. The aim of the present study is to investigate the effectiveness of an intensive, goal-directed training associated with education for parents and adolescents in promoting the daily functioning of adolescents with CP. A randomized clinical trial, with 20 adolescents with CP, aged between 12 and 17 years and 11 months, and their respective caregivers. Adolescents will be randomly allocated into one of two groups: (a) intensive training of functional goals with adolescents or (b) intensive functional goal training with adolescents, including parenting and adolescent education strategies.

Detailed Description

Adolescents with cerebral palsy (CP) have limitations to perform daily routine activities. The use of educational strategies associated to an approach based on motor learning principles was found to be effective in promoting motor outcomes in individuals with CP. However, there is a shortage of services focused on the specific needs of adolescents with CP and on the skills considered important for the success of the transition period to adulthood. Complementarily, the literature reveals the scarcity of services that provide educational support to parents on how to deal with the functional limitations of their adolescent children with CP. Therefore, it is possible that the development of an intervention protocol that associates high intensity training with specific functional goals with an educational program for parents and adolescents, can contribute to the provision of rehabilitation services targeted at adolescents with CP and their families. The overall objective of the present study is to investigate the effectiveness of an intensive, goal-directed protocol associated with education for parents and adolescents in promoting the daily functioning of adolescents with CP. A randomized clinical trial will be conducted with 20 adolescents with CP, aged between 12 and 17 years and 11 months, and their respective caregivers. Adolescents will be randomly allocated into one of two groups: (a) intensive training of functional goals with adolescents (3 hours/day, 5 days/week, during two weeks, totaling 30 hours, in a clinical setting) or (b) intensive functional goal training with adolescents, including parenting and adolescent education strategies (3 hours/day, 5 days/week, during two weeks, totaling 30 hours, with telehealth strategies and visits at the clinical setting).

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Individualized goal training

This group will be submitted to individualized goal training, 3 hours/day, 5 times/week, over the course of two weeks, totaling 30 hours. Training will happen in a clinical setting. Adolescents will select their functional goals to be trained during the intervention period.

Group Type: ACTIVE_COMPARATOR

Individualized goal training

Intervention Type: OTHER

This group will be submitted to individualized goal training, 3 hours/day, 5 times/week, over the course of two weeks, totaling 30 hours. Training will happen in a clinical setting. Adolescents will select their functional goals to be trained during the intervention period.

Individualized goal training with educational strategies

This group will be submitted to individualized goal training with their caregivers, for 2 weeks, with 5 face-to-face meetings lasting 3 hours a day at the rehabilitation center. The other 5 meetings will be held online with the adolescent and their caregiver at the same time, via video communication platform. Adolescents will select their functional goals to be trained during the intervention period.

Group Type: EXPERIMENTAL

Individualized goal training with educational strategies

Intervention Type: OTHER

This group will be submitted to individualized goal training with their caregivers, for 2 weeks, with 5 face-to-face meetings lasting 3 hours a day at the rehabilitation center. The other 5 meetings will be held online with the adolescent and their caregiver at the same time, via video communication platform. Adolescents will select their functional goals to be trained during the intervention period.

Interventions

Individualized goal training

This group will be submitted to individualized goal training, 3 hours/day, 5 times/week, over the course of two weeks, totaling 30 hours. Training will happen in a clinical setting. Adolescents will select their functional goals to be trained during the intervention period.

Intervention Type: OTHER

Individualized goal training with educational strategies

This group will be submitted to individualized goal training with their caregivers, for 2 weeks, with 5 face-to-face meetings lasting 3 hours a day at the rehabilitation center. The other 5 meetings will be held online with the adolescent and their caregiver at the same time, via video communication platform. Adolescents will select their functional goals to be trained during the intervention period.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adolescents with: (a) medical diagnosis of CP (unilateral or bilateral); (b) age between 12 and 17 years and 11 months; (c) manual ability Classified by the Manual Ability Classification System - MACS, at levels I (adolescents capable of handling objects of effectively and independently) to III (adolescents with limited repertoire of activities, who handle objects with supervision or adaptation); (d) gross motor function classified by the Gross Motor Function Classification System - GMFCS Expanded and Revised (GMFCS E & R), in the levels I (adolescents who walk in different contexts, but have limited speed, balance and coordination to run and jump) to IV (adolescents who use a wheelchair in most contexts, but are able to sustain weight on their lower limbs to help in transfers and walking short distances with physical help from a person); (e) communication function classified by the Communication Function Classification System for Individuals with Cerebral Palsy (CFCS) at levels: I (communicates at a appropriate pace with little or no delay in understanding, elaborating a speech, or resolve a misunderstanding); II (independently alternates sender and receiver roles with most people in most situations, but the pace of conversation is slow).

Exclusion Criteria

• Adolescents undergoing any type of intensive intervention, orthopedic surgery or application of botulinum toxin in the upper limbs and/or less than six months will be excluded.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Minas Gerais

OTHER

Sponsor Role: lead

Responsible Party

MARINA B BRANDAO

Adjunct professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Marina de Brito Brandão

Belo Horizonte, Minas Gerais, Brazil

Countries

Brazil

Central Contacts

Marina Brandão, PhD

Role: CONTACT

marinabbrandao@gmail.com

+55 31 988396466

Aline Feitosa, MSc

Role: CONTACT

alinemfei@hotmail.com

+55 31 974008707

References

Feitosa AM, Mancini MC, Silverio APM, Gordon AM, Brandao MB. "Help Me to Improve my Own Priorities!": A Feasibility Study of an Individualized Intensive Goal Training for Adolescents with Cerebral Palsy. Phys Occup Ther Pediatr. 2021;41(6):601-619. doi: 10.1080/01942638.2021.1891186. Epub 2021 Mar 2.

Reference Type: BACKGROUND

PMID: 33653225 (View on PubMed)

Other Identifiers

63692422.0.0000.5149

Identifier Type: -

Identifier Source: org_study_id