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Resistance Intensive Personal Training for Youth With Cerebral Palsy (RIPT)

Primary Purpose

Cerebral Palsy, Exercise, Resistance Training

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Resistance Intensive Personal Training
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cerebral Palsy focused on measuring Cerebral Palsy, CP, Exercise, Strength Training, Power Training, Youth

Eligibility Criteria

8 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Resistance Intensive Personal Training (RIPT)

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Canadian Occupational Performance Measure
    Evidence based outcome measure designed to capture clients self-perception of performance in everyday living over time.
    Goal Attainment Scale
    Individualized outcome measure involving goal selection and goal scaling that is standardized in order to calculate the extent to which a patient's goals are met.

    Secondary Outcome Measures

    Gross Motor Function Measure
    Evaluates change that occurs over time in the gross motor function of children with cerebral palsy.
    Muscle power assessment
    Objective measure of muscle power using voluntary contractions based on muscles involved in goal setting for individual participants.
    EQ-5D-Y
    Measure of health related quality of life in children and adolescents.

    Full Information

    First Posted
    February 7, 2023
    Last Updated
    February 7, 2023
    Sponsor
    University of Calgary
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05731609
    Brief Title
    Resistance Intensive Personal Training for Youth With Cerebral Palsy
    Acronym
    RIPT
    Official Title
    Exploration of the Effectiveness and Feasibility of a Personalized Power Training Program for Youth With Cerebral Palsy Provided Through a Community-tertiary Hospital Partnership.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 2023 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    June 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Calgary

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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: 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? 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: 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? What are the barriers and facilitators to delivery of RIPT in a community setting for youth, caregivers, clinicians, and program staff? Methods: We 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 we 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. We 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 us 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. We 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebral Palsy, Exercise, Resistance Training
    Keywords
    Cerebral Palsy, CP, Exercise, Strength Training, Power Training, Youth

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    12 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Resistance Intensive Personal Training (RIPT)
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Resistance Intensive Personal Training
    Intervention Description
    Personalized power training program focused on participant goals.
    Primary Outcome Measure Information:
    Title
    Canadian Occupational Performance Measure
    Description
    Evidence based outcome measure designed to capture clients self-perception of performance in everyday living over time.
    Time Frame
    14 weeks (from time of consent to end of trial).
    Title
    Goal Attainment Scale
    Description
    Individualized outcome measure involving goal selection and goal scaling that is standardized in order to calculate the extent to which a patient's goals are met.
    Time Frame
    14 weeks (from time of consent to end of trial).
    Secondary Outcome Measure Information:
    Title
    Gross Motor Function Measure
    Description
    Evaluates change that occurs over time in the gross motor function of children with cerebral palsy.
    Time Frame
    14 weeks (from time of consent to end of trial).
    Title
    Muscle power assessment
    Description
    Objective measure of muscle power using voluntary contractions based on muscles involved in goal setting for individual participants.
    Time Frame
    14 weeks (from time of consent to end of trial).
    Title
    EQ-5D-Y
    Description
    Measure of health related quality of life in children and adolescents.
    Time Frame
    14 weeks (from time of consent to end of trial).

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Benjamin M Norman
    Phone
    403-955-5528
    Email
    poni.lab@ucalgary.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Elizabeth Condliffe
    Phone
    403-955-2549
    Email
    elizabeth.condliffe@ucalgary.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Elizabeth Condliffe
    Organizational Affiliation
    University of Calgary
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    There is an open science plan to share de-identified IPD. All data collected in the study will be de-identified and added to a database. Access by other researchers must be requested and agree to a Terms of Use agreement before access is granted.
    IPD Sharing Time Frame
    Data will become available at the end of the study. There is no plan to close the database.
    IPD Sharing Access Criteria
    Researchers requesting access to the database will be required to sign a Terms of Use agreement.

    Learn more about this trial

    Resistance Intensive Personal Training for Youth With Cerebral Palsy

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