Postural Control Under Different Cognitive Loads in Adult Survivors of Acute Lymphoblastic Leukemia and Age-Matched Healthy Individuals
2 other identifiers
observational
92
1 country
1
Brief Summary
The purpose of this study is to determine if adult survivors of childhood Acute Lymphoblastic Leukemia (ALL) enrolled on the SJLife (St. Jude Life) protocol are at increased risk for postural control deficits compared to individuals with no cancer history. All participants will be assessed for their ability to maintain an upright posture, walk at their usual speed, and to tandem walk, all while engaged in a cognitive task. Primary Objective To compare changes in postural control in ALL survivors to changes in postural control in healthy controls, matched on age- and sex- in simple versus complex standing and walking activities (complex: standing or walking with added cognitive load). Secondary Objective To identify demographic and performance related risk factors for decreased postural control during complex standing or walking activities in survivors and controls and to evaluate associations between treatment and the changes in postural control during complex activities among survivors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2018
CompletedFirst Posted
Study publicly available on registry
July 10, 2018
CompletedStudy Start
First participant enrolled
October 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 27, 2021
CompletedSeptember 19, 2022
September 1, 2022
1.3 years
June 18, 2018
September 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Regular gait speed
Regular gait will be evaluated in three different testing conditions: regular gait assessment while participants are engaged in performing a challenging cognitive task (2-back), regular gait assessment while participants are engaged in performing an easy cognitive task (0-bak) and regular gait assessment with no additional cognitive load (baseline). In each condition, the difference in gait speed of each survivor and his/her matched control will be obtained. Then the obtained differences at regular gait assessment with no additional cognitive load (baseline) and regular gait while performing the challenging cognitive task (2-bck) will be compared using a paired t-test.
Up to 1 hour
Composite score from standing balance test
Standing balance ability will be examined in three different testing conditions: standing balance while participants are engaged in performing a challenging cognitive task (2-back), standing balance while participants are engaged in performing an easy cognitive task (0-back), and standing balance assessment with no additional cognitive load. In each condition, the difference in composite score of each survivor and his/her matched control will be obtained. Then the obtained differences at standing balance assessment with no additional cognitive load (baseline) and standing balance assessment while performing the challenging cognitive task (2-back) will be compared using a paired t-test.
Up to 1 hour
Study Arms (2)
ALL Survivors
Adult survivors of Acute Lymphoblastic Leukemia (ALL) enrolled on the SJLIFE protocol
Control Group
Healthy Individuals with no history of childhood or adult onset cancer, matched on age- and sex
Eligibility Criteria
Study population will include 50 Adults survivors of childhood Acute Lymphoblastic Leukemia (ALL) enrolled on the SJLife protocol, and 50 healthy controls matched on age- and sex.
You may qualify if:
- Diagnosis of childhood ALL
- At least 5 years post ALL diagnosis
- No history of secondary malignancies after an ALL diagnosis
- Enrollment on the SJLIFE protocol
- Ages 18.00 to 39.99
- Ability to stand and walk for 20 seconds or more
- Ability to answer the eligibility questions
- Ability to provide informed consent
- No history of childhood or adult onset cancer
- Enrollment on the SJLIFE protocol
- Ages 18.00 to 39.99
- Ability to stand and walk for 20 seconds or more
- Ability to answer the eligibility questions
- Ability to provide informed consent
- Male and females of all races and ethnic groups are eligible
You may not qualify if:
- Currently receiving treatment for cancer
- Weight ≥ 300 lb (the balance system has a weight limit)
- Does not speak English
- Self-reports of hearing issues
- Pregnant females
- Inability or unwillingness of research participant to give written informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kristen K Ness, PhD
St. Jude Children's Reearch Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2018
First Posted
July 10, 2018
Study Start
October 2, 2018
Primary Completion
February 2, 2020
Study Completion
April 27, 2021
Last Updated
September 19, 2022
Record last verified: 2022-09