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
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
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
NCT ID
NCT05731609
First Posted
February 7, 2023
Last Updated
February 7, 2023
Sponsor
University of Calgary
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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