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Cerebral PalsyRIPTNCT05731609

Resistance Intensive Personal Training for Youth with Cerebral Palsy

A study testing Resistance Intensive Personal Training in people with Cerebral Palsy and Exercise, run by University of Calgary at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 8 to 17 years
Conditions the study is for
Cerebral Palsy, Exercise, Resistance Training
What is being tested?
Resistance Intensive Personal Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteCanada
Study dates
13 Mar 2023to Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Benjamin M Norman contact

403-955-5528

poni.lab@ucalgary.ca

Canada1 site, 1 recruiting
  • Alberta Children's Hospital

    Calgary, Alberta, T2N 1N4

    Benjamin Norman, MSc, 4038301494, poni.lab@ucalgary.ca

    Recruiting

Other trials in Canada

About this study

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

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?
Read the 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.

Being tested
Resistance Intensive Personal Training
Keywords
Cerebral Palsy, CP, Exercise, Strength Training, Power Training, Youth
Medical subject headings
Cerebral Palsy, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Resistance Intensive Personal TrainingOther

    Personalized power training program focused on participant goals.

Study groups in NCT05731609
Study groupRoleWhat they receive
Resistance Intensive Personal Training (RIPT)ExperimentalAll 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.
Receives: Other: Resistance Intensive Personal Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Canadian Occupational Performance Measure

    Evidence based outcome measure designed to capture clients self-perception of performance in everyday living over time. Scores are rated on a scale of 1-10, where 1 is the least satisfaction and 10 is the most satisfaction.

    Measured: 14 weeks (from time of consent to end of trial).

  2. 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. Scoring is on a scale of -2 to +2, where -2 is no change, 0 is achieving the goal, and +2 is exceeding the goal.

    Measured: 14 weeks (from time of consent to end of trial).

Secondary outcomes (3)
  1. Gross Motor Function Measure

    Evaluates change that occurs over time in the gross motor function of children with cerebral palsy.

    Measured: 14 weeks (from time of consent to end of trial).

  2. Muscle power assessment

    Objective measure of muscle power using voluntary contractions based on muscles involved in goal setting for individual participants.

    Measured: 14 weeks (from time of consent to end of trial).

  3. EQ-5D-Y

    Measure of health related quality of life in children and adolescents. Health is rated on a scale of 1 to 100, where 1 is the worst health and 100 is the best health.

    Measured: 14 weeks (from time of consent to end of trial).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2023
  2. Study start13 Mar 2023
  3. Primary completionJun 2025 (estimated)
  4. Study completionJun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05731609
Sponsor's protocol ID
REB22-1701
Acronym
RIPT
Status last verified
May 2024
First submitted
7 Feb 2023
Last updated
24 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Resistance Intensive Personal Training in people with Cerebral Palsy and Exercise, run by University of Calgary at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Benjamin M Norman (403-955-5528, poni.lab@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Canadian Occupational Performance Measure (time frame: 14 weeks (from time of consent to end of trial).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.

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