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

Childhood Cancer Clinical Trial

— JUMP  

Official title:

Examining a Fast Movement Approach to Pediatric Therapy Intervention in Children and Adolescents That Have Completed Medical Treatment for Acute Lymphoblastic Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05086354
• Other study ID #: HP-00078339
• Status: Completed
• Phase: N/A
• Start date: March 16, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2022
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Childhood Cancer
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Behavioral:
• JUMP
Warm-up, stretching, jumping rope, cool-down

Locations

Country	Name	City	State
United States	University of Maryland School of Medicine Dept. of Physical Therapy & Rehabilitation Science	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Children's Assessment of Participation and Enjoyment (CAPE) questionnaire.	The CAPE are designed for use with children ages 6-21 years old.	10 minutes
Secondary	electromyography (EMG)	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.	5 minutes
Secondary	Preferences for Physical Activity for Children (PAC)	This is a survey to explore physical activity preferences of children.	10 minutes
Secondary	Vertical Jump Height	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".	5 minutes
Secondary	Peak vertical ground reaction	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	5 minutes
Secondary	Motion Capture Analysis	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).	5 minutes