Ignite Creation Date:
2024-05-06 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05731609
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2023-02-07
Brief Title:
Resistance Intensive Personal Training for Youth With Cerebral Palsy
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RIPT
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
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 Childrens 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 11 support for each participants power training 1 hourday 2-3 daysweek 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 ie 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 participants 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 Scales 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
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 Childrens 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 11 support for each participants power training 1 hourday 2-3 daysweek 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 ie 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 participants 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 Scales 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None