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Completed

NCT Number: NCT05086354

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

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.

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Key information

Conditions

Childhood Cancer Neoplasms

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Baltimore, Maryland, 21201-1082, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

JUMP

Behavioral

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

Primary outcomes

  1. Gross Motor Proficiency

    Time frame: 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 outcomes

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

    Time frame: 10 minutes

    The CAPE are designed for use with children ages 6-21 years old.

  2. electromyography (EMG)

    Time frame: 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.

  3. Preferences for Physical Activity for Children (PAC)

    Time frame: 10 minutes

    This is a survey to explore physical activity preferences of children.

  4. Vertical Jump Height

    Time frame: 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".

  5. Peak vertical ground reaction

    Time frame: 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

  6. Motion Capture Analysis

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study title

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

Acronym: JUMP

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Oct 20, 2021
Registry last updated
Feb 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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