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Examining a Training Program for for Acute Lymphoblastic Leukemia Childhood Cancer Survivors (JUMP)

Primary Purpose

Childhood Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
JUMP
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Cancer focused on measuring physical therapy, functional mobility

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

One group that all receive the intervention of jumping rope.

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Children's Assessment of Participation and Enjoyment (CAPE) questionnaire.
The CAPE are designed for use with children ages 6-21 years old.
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.
Preferences for Physical Activity for Children (PAC)
This is a survey to explore physical activity preferences of children.
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".
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
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).

Full Information

First Posted
September 27, 2021
Last Updated
February 10, 2022
Sponsor
University of Maryland, Baltimore
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1. Study Identification

Unique Protocol Identification Number
NCT05086354
Brief Title
Examining a Training Program for for Acute Lymphoblastic Leukemia Childhood Cancer Survivors
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 16, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Cancer
Keywords
physical therapy, functional mobility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Feasibility study
Masking
None (Open Label)
Masking Description
the physical therapist performing the baseline and post-training does not have involvement with the intervention
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
One group that all receive the intervention of jumping rope.
Arm Type
Experimental
Arm Description
All participants will be in one group. Every participant receives the same intervention.
Intervention Type
Behavioral
Intervention Name(s)
JUMP
Intervention Description
Warm-up, stretching, jumping rope, cool-down
Primary Outcome Measure Information:
Title
Gross Motor Proficiency
Description
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.
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
Children's Assessment of Participation and Enjoyment (CAPE) questionnaire.
Description
The CAPE are designed for use with children ages 6-21 years old.
Time Frame
10 minutes
Title
electromyography (EMG)
Description
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.
Time Frame
5 minutes
Title
Preferences for Physical Activity for Children (PAC)
Description
This is a survey to explore physical activity preferences of children.
Time Frame
10 minutes
Title
Vertical Jump Height
Description
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".
Time Frame
5 minutes
Title
Peak vertical ground reaction
Description
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
Time Frame
5 minutes
Title
Motion Capture Analysis
Description
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).
Time Frame
5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victoria Marchese, PT, PhD
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland School of Medicine Dept. of Physical Therapy & Rehabilitation Science
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201-1082
Country
United States

12. IPD Sharing Statement

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

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