Clinical trial NCT05086354: Examining a Training Program for for Acute Lymphoblastic Leukemia Childhood Cancer Survivors
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
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Cancer
Keywords: physical therapy
functional mobility
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2021-10-20
Enrollment: 10
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility study
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Gross Motor Proficiency
timeFrame: 20 minutes
Secondary outcomes:
measure: Children's Assessment of Participation and Enjoyment (CAPE) questionnaire.
timeFrame: 10 minutes
measure: electromyography (EMG)
timeFrame: 5 minutes
measure: Preferences for Physical Activity for Children (PAC)
timeFrame: 10 minutes
measure: Vertical Jump Height
timeFrame: 5 minutes
measure: Peak vertical ground reaction
timeFrame: 5 minutes
measure: Motion Capture Analysis
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland School of Medicine Dept. of Physical Therapy & Rehabilitation Science
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Victoria Marchese, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: