Postural Control Under Different Cognitive Loads in Adult Survivors of Acute Lymphoblastic Leukemia and Age-Matched Healthy Individuals
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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Tennessee
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Memphis, Tennessee, Spojené státy, 38105
- St. Jude Children's Research Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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ALL Survivors
Adult survivors of Acute Lymphoblastic Leukemia (ALL) enrolled on the SJLIFE protocol
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Control Group
Healthy Individuals with no history of childhood or adult onset cancer, matched on age- and sex
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Regular gait speed
Časové okno: Up to 1 hour
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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.
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Up to 1 hour
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Composite score from standing balance test
Časové okno: Up to 1 hour
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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.
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Up to 1 hour
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Kristen K Ness, PhD, St. Jude Children's Reearch Hospital
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- PCALL
- NCI-2018-01471 (Identifikátor registru: NCI Clinical Trial Registration Program)
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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