Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05731609 |
| Other study ID # |
REB22-1701 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 13, 2023 |
| Est. completion date |
June 2025 |
Study information
| Verified date |
May 2024 |
| Source |
University of Calgary |
| Contact |
Benjamin M Norman |
| Phone |
403-955-5528 |
| Email |
poni.lab[@]ucalgary.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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?
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.
