Intensive Goal Training With Educational Strategies for Adolescents With Cerebral Palsy

NCT05635565 | Unknown

• 1 other identifier: 63692422.0.0000.5149
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

• Canadian Occupational Performance Measure (COPM)

  Canadian Occupational Performance Measure (COPM) - performance and satisfaction scales (each scale ranging 1-10; higher values, better outcomes)

  4 Months

Secondary Outcomes (5)

• Pediatric Evaluation of Disability Inventory- Computer Adaptive Test

  4months

• Domains of Mastery Motivation (DMQ) - Self-reported

  4 months

• Domains of Mastery Motivation (DMQ) - Parent- report

  4 months

• Depression, Anxiety and Stress Scales (DASS-21)

  4 months

• Depression, Anxiety and Stress Scale for Adolescents (EDAE-A)

  4 months

Study Arms (2)

Individualized goal training

ACTIVE COMPARATOR

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.

Other: Individualized goal training

Individualized goal training with educational strategies

EXPERIMENTAL

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.

Other: Individualized goal training with educational strategies

Interventions

Individualized goal training 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

Individualized goal training with educational strategies 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.

Individualized goal training with educational strategies

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (1)

Marina de Brito Brandão

Belo Horizonte, Minas Gerais, 30431-232, Brazil

Location

Related Publications (1)

• 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.

  PMID: 33653225 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Marina Brandão, PhD

CONTACT

+55 31 988396466; marinabbrandao@gmail.com

Aline Feitosa, MSc

CONTACT

+55 31 974008707; alinemfei@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor will not have access to the group allocation of the participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct professor

Model Details: Randomized clinical trial with 2 groups

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 2, 2022
• Study Start: December 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: July 1, 2024
• Last Updated: December 2, 2022

Record last verified: 2022-11

Locations

BR (1)