Postural Control Under Different Cognitive Loads in Adult Survivors of Acute Lymphoblastic Leukemia and Age-Matched Healthy Individuals

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Brief Title

Postural Control Under Different Cognitive Loads in Adult Survivors of Acute Lymphoblastic Leukemia and Age-Matched Healthy Individuals

Official Title

Postural Control Under Different Cognitive Loads in Adult Survivors of Acute Lymphoblastic Leukemia and Age-Matched Healthy Individuals

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.
    

Detailed Description

      Cognitive performance (attention and working memory) will be evaluated using the auditory
      N-Back test. The 0-back condition and the 2-back condition will be used. After cognitive
      assessment, participants will perform 3 different postural control tasks (standing balance,
      regular gait, and tandem gait) in a random order. Postural tasks for each participant will be
      determined by using random allocation envelopes.

      Computerized dynamic posturography will be used to evaluate standing balance with no added
      cognitive load. Standing balance assessment will be repeated two more times, once with
      participants engaged in performing the auditory 0-back task, and then with simultaneously
      performing the auditory 2-back task. Regular gait at participants' preferred speed will be
      examined using 6 light-weight wearable inertial sensors. The regular walking assessment will
      be repeated with simultaneous performance of the 0-back task and then with simultaneous
      engagement in the 2-back task. We have also included a tandem gait (placing one foot directly
      in front of the other) in order to make the postural task more challenging. The wearable
      inertial sensors will be used to record participants' gait characteristics while tandem
      walking. The tandem walk assessment will be repeated once with the participant simultaneously
      perform the 0-back task and then with the 2-back task. The estimated required time to perform
      all of the assessments and with inclusion of 3 rest intervals is 2 hours.

      In addition, data from the overall SJLIFE assessment will be used in analysis.
    


Study Type

Observational


Primary Outcome

Regular gait speed


Condition

Acute Lymphoblastic Leukemia


Study Arms / Comparison Groups

 ALL Survivors
Description:  Adult survivors of Acute Lymphoblastic Leukemia (ALL) enrolled on the SJLIFE protocol

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

100

Start Date

October 2, 2018

Completion Date

December 31, 2020

Primary Completion Date

March 31, 2020

Eligibility Criteria

        Inclusion Criteria - Cases:

          -  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

        Inclusion Criteria - Controls:

          -  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

        Inclusion of Women and Minorities:

        • Male and females of all races and ethnic groups are eligible

        Exclusion Criteria:

          -  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.
      

Gender

All

Ages

18 Years - 39 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Kristen K Ness, PhD, 866-278-5833, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03581045

Organization ID

PCALL

Secondary IDs

NCI-2018-01471

Responsible Party

Sponsor

Study Sponsor

St. Jude Children's Research Hospital


Study Sponsor

Kristen K Ness, PhD, Principal Investigator, St. Jude Children's Reearch Hospital


Verification Date

January 2020