Pediatric Early Rehabilitation in Acute Lymphoblastic Leukemia

NCT06170385 | Completed

• 1 other identifier: HREBA.CC-23-0294
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the feasibility and acceptability of a hybrid in-person and virtual individualized physiotherapy program using the Healthy Eating and Active Living (HEAL-ME) online platform for children diagnosed with acute lymphoblastic leukemia. We would like to know if this type of hybrid program delivery model is feasible, and if children and their parents are willing and able to participate in the program. We will do this by recording how many, and what type of physiotherapy sessions (in-person or virtual) are completed, what resources offered on the platform are accessed, and how many children complete the assessments.

Conditions

Neoplasms; Pediatric Cancer; Physical Therapy; Telemedicine

Outcome Measures

Primary Outcomes (1)

• Retention rate

  The number of participants completing the intervention and assessments

  Post-intervention: 12 weeks

Secondary Outcomes (5)

• Recruitment rate

  One year

• Adherence to study intervention

  Post-intervention: 12 weeks

• Adverse events

  One year

• Acceptability

  Post-intervention: 12 weeks

• Health-related Quality of Life

  Post-intervention: 12 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

Children will participate in six PT sessions over the course of 12 weeks and will be provided with the option to choose their preferred mode of the delivery (i.e., 1:1 in-person, 1:1 virtual, group virtual, or a combination of all). The program will be tailored to the child's age, presenting symptoms, and preferred activities. Children and parents/ caregivers will be encouraged to carry out additional tailored PT sessions through their preferred mode of delivery and to access the exercise videos provided in the additional resources section of the HEAL-ME platform.

Behavioral: Physical Therapy

Interventions

Physical Therapy BEHAVIORAL

Each physical therapy session will commence with a 5-minute warm-up, with fun activities to mobilize the joints and activate the muscles, using the videos available in the HEAL-ME platform. The warm-up session will be followed by a 20 to 40-min program with tailored activities and games comprising jumping, squatting, skipping, balancing, and jogging. The session will finish with a 5-minute cool down with stretching exercises and a relaxation video from the HEAL-ME platform.

Intervention

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children diagnosed with acute lymphoblastic leukemia aged between 4 and 17 years (at time of diagnosis) and their mother, father, or primary carer;
• Undergoing or completed cancer treatment as established by the Children's Oncology Group;
• Access to the internet through a home computer or tablet;
• Patient or caregiver is able to speak and comprehend English; and
• The child is approved by their Oncologist to participate in the program.

You may not qualify if:

• Children with a history of a neurodevelopmental or genetic disorder (i.e., Down syndrome, autism, seizure disorder) prior to the cancer diagnosis; and
• Children with a concurrent condition (illness, disease, psychiatric disorder), as determined by oncologist or physiotherapist, that would compromise study participation or interpretation of study results.

Sponsors & Collaborators

• Alberta Health services: collaborator
• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G2R3, Canada

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Margaret McNeely, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Quasi-experimental single group before and after study

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: December 14, 2023
• Study Start: April 15, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: when the study has been completed and after the findings are published
• Access Criteria: Open access

Locations

CA (1)