Resistance Intensive Personal Training for Youth with Cerebral Palsy

NCT ID: NCT05731609

Last Updated: 2025-01-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-13
• Study Completion Date: 2025-06-30

Brief Summary

Changes related to Cerebral Palsy (CP) include differences in muscle architecture and cortical activity. These result in weakness, decreased functional ability and limited participation in physical activity. Strength training programs, particularly those including power training components, show great potential in improving the gross motor function of youth with CP. However, this intervention is not currently offered in the Calgary area. Delivered via an innovative partnership with community stakeholders, this project will investigate the preliminary effectiveness of the program to enable youth with CP to achieve child and family centered goals. It will also investigate the feasibility of offering this type of program via a community-hospital partnership.

Research Question & Objectives:

1. Can youth with cerebral palsy achieve their goals and improve their motor function through RIPT (Resistance Intensive Personal Training), a power training program offered jointly by specialized physiotherapists and fitness professionals in community settings?

2. What are the barriers and facilitators to delivery of RIPT in a community setting for youth, caregivers, clinicians, and program staff?

Detailed Description

Changes related to Cerebral Palsy (CP) include differences in muscle architecture and cortical activity. These result in weakness, decreased functional ability and limited participation in physical activity. Strength training programs, particularly those including power training components, show great potential in improving the gross motor function of youth with CP. However, this intervention is not currently offered in the Calgary area. Delivered via an innovative partnership with community stakeholders, this project will investigate the preliminary effectiveness of the program to enable youth with CP to achieve child and family centered goals. It will also investigate the feasibility of offering this type of program via a community-hospital partnership.

Research Question & Objectives:

1. Can youth with cerebral palsy achieve their goals and improve their motor function through RIPT (Resistance Intensive Personal Training), a power training program offered jointly by specialized physiotherapists and fitness professionals in community settings?

2. What are the barriers and facilitators to delivery of RIPT in a community setting for youth, caregivers, clinicians, and program staff?

Methods:

Study investigators will conduct a mixed-methods experimental prospective cohort study. Two 12-week sessions of RIPT will be offered at the Mount Royal University community recreation centre and delivered in partnership by physiotherapists from Alberta Children's Hospital and community-based fitness professionals with additional support from students at Mount Royal University (training partners). Six youth with CP (aged 8-17, able to follow directions in English and exert a maximal effort with support) will participate in each session with 1:1 support for each participant's power training 1 hour/day, 2-3 days/week in a group setting. At recruitment potential barriers to regular attendance will be explored with an ACH Neurosciences Social Worker available to support as needed. Each participant and their family will generate individual goals using the Canadian Occupational Performance Measure and their individualized program will be tailored to target the movements and muscles needed to achieve each goal by physiotherapists trained in the RIPT protocol.

This study is designed to evaluate if this practical implementation of the program is effective (i.e. can produce similar effect size as measured in randomized-controlled efficacy trials). Motor function will be measured with the gold-standard clinical scale in this population, Gross Motor Function Measure, and objective evaluation of muscle power using the isotonic mode on our Biodex Dynamometer. Both of these outcomes have established effect sizes. Further, study investigators will move the assessment approach to focus on the individual goals identified by the COPM as part of creating the training program by linking each one to the Goal Attainment Scale. For example, a participant's goal to be able to walk to the bus faster, can be objectively evaluated using a validated measure such as the 6-minute Walk Test. Changes in each of these objective outcomes can be prospectively mapped to the Goal Attainment Scale's ordinal rankings to enable repeated-measures analysis of outcomes based on those most salient to an individual. Study investigators will also use EQ-5DY to evaluate quality of life as comments from our pilot clinical program suggest the benefits were quite broad. These outcomes will be collected at baseline 8, and 12 weeks. The change between baseline and 12-weeks represents the key outcome to demonstrate effectiveness. Patient partners feel a shorter program would be more feasible for more participants and one previous study has shown efficacy at 8 weeks. Therefore, the 8-week time point will allow study investigators to explore if participant goals can be met on this shorter timeline.

Following training, youth and their families will complete the Measure of Processes of Care (MPOC 20) and participate in individual family focus-groups. Training partners will complete the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) which are valid and reliable measures of implementation outcomes. Study investigators will also explore the barriers and facilitators to program delivery via semi-structured interviews with the training partners. Interviews will be anonymized and transcribed. Thematic analysis of the transcripts will assess each domain: barriers, facilitators, and perceived impacts of RIPT.

Conditions

Cerebral Palsy; Exercise; Resistance Training

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Resistance Intensive Personal Training (RIPT)

All participants will participate in this arm involving 12 weeks of training 2-3 days/week in a group setting with each session involving 1:1 support for each participant's power training.

Group Type: EXPERIMENTAL

Resistance Intensive Personal Training

Intervention Type: OTHER

Personalized power training program focused on participant goals.

Interventions

Resistance Intensive Personal Training

Personalized power training program focused on participant goals.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• At least 8 years old
• 17 years old or younger
• able to follow directions in English
• able to exert maximum effort

Exclusion Criteria

• Less than 8 years old
• 18 years old or older
• unable to follow directions in English
• unable to exert maximum effort
• acute pathology of the body part to be trained (e.g. injury or surgery)
• A very high degree of neuromotor impairment (GMFCS 5, MACS 4/5) as we are unable to provide mechanical lifts and transfers

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Condliffe, PhD MD

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth Condliffe

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

Alberta Children's Hospital

Calgary, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Benjamin M Norman

Role: CONTACT

poni.lab@ucalgary.ca

403-955-5528

Elizabeth Condliffe

Role: CONTACT

elizabeth.condliffe@ucalgary.ca

403-955-2549

Facility Contacts

Benjamin Norman, MSc

Role: primary

poni.lab@ucalgary.ca

4038301494

Other Identifiers

REB22-1701

Identifier Type: -

Identifier Source: org_study_id