NCT05731609

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. 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. 2.What are the barriers and facilitators to delivery of RIPT in a community setting for youth, caregivers, clinicians, and program staff?

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 16, 2023

Completed
25 days until next milestone

Study Start

First participant enrolled

March 13, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

January 24, 2025

Status Verified

May 1, 2024

Enrollment Period

2.2 years

First QC Date

February 7, 2023

Last Update Submit

January 21, 2025

Conditions

Keywords

Cerebral PalsyCPExerciseStrength TrainingPower TrainingYouth

Outcome Measures

Primary Outcomes (2)

  • 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.

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

  • 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.

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

Secondary Outcomes (3)

  • Gross Motor Function Measure

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

  • Muscle power assessment

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

  • EQ-5D-Y

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

Study Arms (1)

Resistance Intensive Personal Training (RIPT)

EXPERIMENTAL

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.

Other: Resistance Intensive Personal Training

Interventions

Personalized power training program focused on participant goals.

Resistance Intensive Personal Training (RIPT)

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Less than 8 years old
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alberta Children's Hospital

Calgary, Alberta, T2N 1N4, Canada

RECRUITING

MeSH Terms

Conditions

Cerebral PalsyMotor Activity

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBehavior

Study Officials

  • Elizabeth Condliffe

    University of Calgary

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin M Norman

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

February 7, 2023

First Posted

February 16, 2023

Study Start

March 13, 2023

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

January 24, 2025

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
Data will become available at the end of the study. There is no plan to close the database.
Access Criteria
Researchers requesting access to the database will be required to sign a Terms of Use agreement.

Locations