Rehabilitation Hospital of Indiana
Indianapolis, Indiana, 46254, United States
Location status: Recruiting
Location contact
Alicia Ward, MS
CONTACT
Christopher Henderson, PhD
PRINCIPAL_INVESTIGATOR
Thomas G Hornby, PhD
SUB_INVESTIGATOR
NCT Number: NCT06612723
The purpose of this pilot study is to investigate the potential role of training frequency on locomotor outcomes following high-intensity gait training and provision of a home walking program.
Interested in participating?
Request Info18 year–85 year
All sexes
Interventional
Not applicable
Indianapolis, Indiana, 46254, United States
Location status: Recruiting
Alicia Ward, MS
CONTACT
Christopher Henderson, PhD
PRINCIPAL_INVESTIGATOR
Thomas G Hornby, PhD
SUB_INVESTIGATOR
This study will utilize a 2 arm randomized trial to investigate potential differences in locomotor and community outcomes following 18 visits of high-intensity gait training provided over 6 weeks (high frequency) or 12 weeks (low frequency). Following confirmation of eligibility and baseline testing, individuals will be randomized to either high or low frequency of training and complete subsequent testing at 6 weeks, 12 weeks, and 24 weeks.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Individuals will perform up to 40 minutes of walking practice during 60 minute sessions while targeting heart rates of at least 70% heart rate reserve.
Individuals will receive feedback on the minutes of walking activity performed on non-training days and provided coaching strategies to increase this metric.
Time frame: After 12 weeks
Individuals will be asked to "cover as much ground as possible" over 6 mins. Heart rate will additionally be measured during this assessment (distance in m)
Time frame: After 12 weeks
Individuals will participate in a walking-based graded exercise test. While harnessed for safety, a motorized treadmill will be initially set to 0.1 m/s and increased by 0.1 m/s each minute until the test is terminated due: 1) requests to stop, 2) unable to keep up with the treadmill and/or loses their balance, 3) absolute exercise test termination criteria provided by ACSM. The highest speed that the individual can walk for a minute at is the peak treadmill speed.
Time frame: After 12 weeks
10 item assessment of dynamic balance. Example tasks include walking with head turns, with eyes closed, and walking backwards.
Time frame: After 12 weeks
Participants will be asked to rise from a chair without using their arms and then return to sitting as many times as possible in 30 seconds.
Time frame: After 12 weeks
This questionnaire asks individuals to rate their balance-confidence from 0 (no confidence) to 100 (completely confident) during a variety of 16 commonly performed tasks such as walking around a house or getting into a car.
Time frame: After 12 weeks
Oxygen consumption will be measured via a portable metabolic cart (K5; COSMED) during the previously described graded exercise test. Participant will wear a snug fitting mask that covers their mouth and nose, but does not affect the amount or quality of air that they breathe. The mask will be connected to a small backpack that collects information on the rate of breathing and oxygen consumed.
Time frame: After 12 weeks
This 36-question survey asks individuals about how their current health may limit their ability to perform typical physical and social activities.
Time frame: After 12 weeks
Participants will wear a research-grade pedometer (StepWatch; Modus Health) during waking hours for ~1-2 weeks before beginning the training protocol, during the intervention period, and after completing training protocol to quantify home and community mobility. Participants will also be asked to document their daily minutes walked for exercise, number of walking bouts, where they performed the activity, and subjectively how hard they were working while walking for exercise.
Time frame: After 12 weeks
This is an assessment of overground walking speed measured across a distance of ~20 feet and will be conducted at both self-selected (instructions: "walk at your usual, comfortable pace") and fastest (instructions: "walk as fast as you safely can") walking speeds on a pressure sensitive mat (speed in m/s; Zeno Walkway).
Contact information is provided by the study sponsor or research team.
Christopher Henderson, PhD
CONTACT
Thomas G Hornby, PhD
CONTACT
Indiana University
Other
Acronym: F-ITT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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