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

Not Applicable

Completed

• Conditions: Childhood Cancer
• Interventions: Behavioral: JUMP

• Registration Number: NCT05086354
• Lead Sponsor: University of Maryland, Baltimore

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.

Detailed Description

We are performing a feasibility study to examine a movement based intervention that utilizes fast movements through jumping rope to improve balance, coordination, movement speed, and movement agility. The abilities to generate fast movements are required to perform functional activities and for playing sports. Participants will receive five in-person PT sessions and a home program for six weeks. The goal of this research is to determine the feasibility, acceptability, and promise of a PT program that emphasizes fast movements in ALL CCS.

Study Timeline

• Study Start: 2018-03-16
• Study First Submitted: 2021-09-27
• Study First Submitted QC: 2021-10-07
• Study First Posted: 2021-10-20
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-10
• Last Update Posted: 2022-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
One group that all receive the intervention of jumping rope.	JUMP	All participants will be in one group. Every participant receives the same intervention.

Primary Outcome Measures

Name	Time	Method
Gross Motor Proficiency	20 minutes	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.

Secondary Outcome Measures

Name	Time	Method
electromyography (EMG)	5 minutes	The EMG onset will be defined by the time when the EMG burst is 3 standard deviations above the baseline muscle activity. The slope of the muscle activity, which is the linear regression line of best fit for the values between the onset of the EMG, and the peak of the EMG burst amplitude will be calculated and normalized by dividing the slope by the peak amplitude. The EMG burst slope reflects the recruitment and firing rate of motor units at the onset of the contraction, which is important for producing fast responses.
Peak vertical ground reaction	5 minutes	participant is asked to jump on the force platform. Takeoff is defined as the highest vertical ground reaction force value attained from the force time record for the takeoff phase of each jump, minus body mass
Motion Capture Analysis	5 minutes	The 3D motion analysis will be captured with a VICON T10 Camera with Nexus Software VICON markers will be placed on each shoe in the position of the great toe, ankle (lateral malleoli), lateral knee (proximal to the apex of the fibular head), greater trochanter of the hip, shoulder (greater tubercle of the humerus), lateral elbow (distal to lateral epicondyle), the wrist (styloid process), and head (wearing a headband).
Children's Assessment of Participation and Enjoyment (CAPE) questionnaire.	10 minutes	The CAPE are designed for use with children ages 6-21 years old.
Preferences for Physical Activity for Children (PAC)	10 minutes	This is a survey to explore physical activity preferences of children.
Vertical Jump Height	5 minutes	Participants will perform five vertical jumps starting in the upright standing position with their feet on two adjacent force platforms. The instructions will be to "jump straight up as high as you can".

Trial Locations

Locations (1)

University of Maryland School of Medicine Dept. of Physical Therapy & Rehabilitation Science; 🇺🇸 Baltimore, Maryland, United States