Examining a Training Program for for Acute Lymphoblastic Leukemia Childhood Cancer Survivors

NCT05086354 | Completed DMC

• 1 other identifier: HP-00078339
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Acute lymphoblastic leukemia (ALL) is the most common pediatric malignancy, with the peak incidences occurring in children two to five years of age. Children with ALL received neurotoxic chemotherapy agents for two to three years that causes decreased distal muscle strength and poor timing of muscle activation. After completion of medical treatment, ALL childhood cancer survivors (ALL CCS) are more likely to have an inactive lifestyle, resulting in life-long gross motor proficiency differences compared to their peers. ALL CCS typically do not utilize physical therapists' expertise after medical treatment has been completed. There are limited physical therapy (PT) intervention studies for ALL CCS.

Conditions

Childhood Cancer

Keywords

physical therapy; functional mobility

Outcome Measures

Primary Outcomes (1)

• Gross Motor Proficiency

  Bruininks-Oseretsky Test of Motor Proficiency 2nd edition (BOT-2) (subtest 4, 5, 6, 8: bilateral coordination, balance, running speed and agility, and strength). The BOT-2 is a reliable and valid norm-referenced instrument designed for children and adolescents 4-21 years old.

  20 minutes

Secondary Outcomes (6)

• Children's Assessment of Participation and Enjoyment (CAPE) questionnaire.

  10 minutes

• electromyography (EMG)

  5 minutes

• Preferences for Physical Activity for Children (PAC)

  10 minutes

• Vertical Jump Height

  5 minutes

• Peak vertical ground reaction

  5 minutes

Study Arms (1)

One group that all receive the intervention of jumping rope.

EXPERIMENTAL

All participants will be in one group. Every participant receives the same intervention.

Behavioral: JUMP

Interventions

JUMP BEHAVIORAL

Warm-up, stretching, jumping rope, cool-down

One group that all receive the intervention of jumping rope.

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children 6-17 years old
• Completed medical treatment for ALL within the past five years (1 to 60 months)
• Speak English.

You may not qualify if:

• Diagnosis of a neurological disorder such as cerebral palsy, Down syndrome
• Currently receiving PT services.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland School of Medicine Dept. of Physical Therapy & Rehabilitation Science

Baltimore, Maryland, 21201-1082, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Victoria Marchese, PT, PhD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: the physical therapist performing the baseline and post-training does not have involvement with the intervention
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Chair

Model Details: Feasibility study

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 20, 2021
• Study Start: March 16, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 11, 2022

Record last verified: 2022-02

Locations

US (1)