An interventional study of Forward First ICARE Training and Reverse First ICARE Training in Neurological Injury and Neurological Diseases or Conditions, sponsored by Madonna Rehabilitation Hospital. Active, not recruiting at 1 site in United States. Open to participants aged 7 Years and older. Per ClinicalTrials.gov, last updated 2023-08-14.
Sponsored by Madonna Rehabilitation Hospital · Not applicable, Interventional, and Treatment
The goal of this study is to determine if training in both the forward and reverse modes on the ICARE (motor-assisted elliptical) contributes to improvements in gait and cardiorespiratory fitness.
A growing number of facilities are using the robotic ICARE, a motor-assisted elliptical, to improve walking and fitness in individuals with physical disabilities. The device promotes movements emulating the joint motions and muscle demands of normal gait and integrates design features that improve accessibility and usability (e.g., motor assistance, partial BWS, electronic height-adjustable seat, steps, ramp, wheelchair platform) compared to traditional ellipticals. A motor assists those with strength and/or endurance limitations to train (forward/reverse directions) at speeds up to 65 cycles per minute (CPM), thus creating opportunities for the mass repetition of a gait-like movement pattern that is often advocated as critical for behavioral and neurologic recovery. Individuals can over-ride the motor's assistance simply by training faster than the set speed. Documented improvements in walking and cardiorespiratory fitness in individuals with neurologic injuries and illnesses following an ICARE training program in the forward direction are promising.
Reverse walking is one method clinicians have used to improve forward walking performance in patients with various neurological disorders. Although the ICARE allows for reverse training, and this feature has been used clinically, no studies to date have compared changes in walking and cardiorespiratory fitness arising from an ICARE training intervention performed in the reverse direction to those arising from an ICARE intervention performed in the forward direction. Thus, the purpose of this exploratory study is to compare gait and cardiorespiratory improvements arising from blocks (12-sessions) of forward vs. reverse ICARE training in participants with walking dysfunction. For this exploratory study, the investigators hypothesize that both forward and reverse training will contribute to improvements in gait and cardiorespiratory fitness. In addition, the investigators seek to understand whether the magnitude of change will differ between each form of training (i.e., forward vs. reverse) and whether the order of training will impact the magnitude of change (i.e. block of 12-sessions forward followed by block of 12-sessions reverse vs. block of 12-sessions reverse followed by block of 12-sessions forward). Measurements will be recorded immediately prior to intervention initiation (T0), following completion of the first training block (T1), immediately following completion of the second training block (T2), and 3 months following completion of the second training block (T3)
80 studies on the registry are indexed under Trauma, Nervous System; 23 are open to participants now.
This study's enrollment of 13 is below the median of 41 across 58 interventional studies indexed under Trauma, Nervous System.
Browse Trauma, Nervous System studies →Madonna Rehabilitation Hospital is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants will engage in 12-sessions in the reverse direction followed by 12-sessions in the forward direction.
Behavioral: Reverse First ICARE Training
Participants will engage in 12-sessions in the forward direction followed by 12-sessions in the reverse direction.
Behavioral: Forward First ICARE Training
Participants will engage in 12-sessions in forward direction, followed by 12-sessions in the reverse direction. Sessions will be scheduled 3 times/week with training parameters adjusted to progressively increase challenge as tolerated.
Participants will engage in 12-sessions in reverse direction, followed by 12-sessions in the forward direction. Sessions will be scheduled 3 times/week with training parameters adjusted to progressively increase challenge as tolerated.
10 Meter Walk Test Speed
Average walking speed while traversing 10 meters
Time frame: 10 minutes
Peak Oxygen Consumption
This test of aerobic capacity quantifies the peak oxygen consumed while walking on a treadmill or rotating a crank ergometer
Time frame: Up to 30 minutes
6 Minute Walk Test
This sub-maximal exercise test measures the maximum distance walked during 6 minutes. It is used to assess aerobic capacity and endurance. Protocol includes 2 minute explanation followed by 6 Minute Walk Test.
Time frame: Up to 2 minute explanation followed by 6 minute formal walk test
Energy Cost of Treadmill Walking
This metabolic test of walking efficiency measures oxygen consumed during treadmill walking and divides it by the treadmill's walking speed.
Time frame: Up to 30 minutes
Cardiorespiratory Response During Treadmill Walking
Ratings of perceived effort during graded exercise test
Time frame: Up to 30 minutes
Cardiorespiratory Response During ICARE Training
Ratings of perceived effort while training on the ICARE
Time frame: Up to 50 minutes
Spatiotemporal Gait Measures
Stride characteristics (e.g., cadence, stride length, single limb support time) recorded while traversing instrumented walkway
Time frame: 20 minutes
Timed Up and Go (TUG) Test
Time required to completed standardized TUG test, a measure used to assess a person's mobility that requires both static and dynamic balance.
Time frame: 8 minutes
Plan to share: No — There is no plan for sharing IPD.
This study is active, not recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Madonna Rehabilitation Hospital