Impact of Reverse vs. Forward ICARE Training Interventions
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| ClinicalTrials.gov Identifier: NCT03480581 |
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Recruitment Status : Unknown
Verified February 2020 by Judith M. Burnfield, PhD, PT, Madonna Rehabilitation Hospital.
Recruitment status was: Recruiting
First Posted : March 29, 2018
Last Update Posted : February 17, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Neurological Injury Neurological Diseases or Conditions | Behavioral: Forward First ICARE Training Behavioral: Reverse First ICARE Training | Not Applicable |
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)
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Impact of Reverse vs. Forward ICARE Training Interventions on Walking and Fitness of Individuals With Walking Disorders Arising From Neurologic Injuries or Illnesses |
| Actual Study Start Date : | June 1, 2018 |
| Estimated Primary Completion Date : | March 2021 |
| Estimated Study Completion Date : | March 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Reverse First ICARE Training
Participants will engage in 12-sessions in the reverse direction followed by 12-sessions in the forward direction.
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Behavioral: Reverse First ICARE Training
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. |
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Experimental: Forward First ICARE Training
Participants will engage in 12-sessions in the forward direction followed by 12-sessions in the reverse direction.
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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. |
- 10 Meter Walk Test Speed [ Time Frame: 10 minutes ]Average walking speed while traversing 10 meters
- Peak Oxygen Consumption [ Time Frame: Up to 30 minutes ]This test of aerobic capacity quantifies the peak oxygen consumed while walking on a treadmill or rotating a crank ergometer
- 6 Minute Walk Test [ Time Frame: Up to 2 minute explanation followed by 6 minute formal 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.
- Energy Cost of Treadmill Walking [ Time Frame: Up to 30 minutes ]This metabolic test of walking efficiency measures oxygen consumed during treadmill walking and divides it by the treadmill's walking speed.
- Cardiorespiratory Response During Treadmill Walking [ Time Frame: Up to 30 minutes ]Ratings of perceived effort during graded exercise test
- Cardiorespiratory Response During ICARE Training [ Time Frame: Up to 50 minutes ]Ratings of perceived effort while training on the ICARE
- Spatiotemporal Gait Measures [ Time Frame: 20 minutes ]Stride characteristics (e.g., cadence, stride length, single limb support time) recorded while traversing instrumented walkway
- Timed Up and Go (TUG) Test [ Time Frame: 8 minutes ]Time required to completed standardized TUG test, a measure used to assess a person's mobility that requires both static and dynamic balance.
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| Ages Eligible for Study: | 7 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Walking dysfunction from a neurologic injury or illness (e.g. stroke, brain injury, incomplete spinal cord injury, multiple sclerosis, Parkinson's disease, cerebral palsy);
- Able to stand (with or without a standing frame) for at least 5 minutes at a time;
- Able to follow simple commands; and
- Possess adequate judgment or communication skills to safely use the ICARE trainer.
Exclusion Criteria:
- Currently enrolled in an existing physical or occupational therapy program or an exercise program for their legs;
- Orthopedic conditions (such as bone fractures/breaks) that haven't healed;
- Unstable cardiac or respiratory conditions that would prohibit safe exercise;
- Pregnant or think they may be pregnant, given unknown but potential risk of vigorous exercise to the mother and/or the unborn fetus; and/or
- Experience self-reported pain that inhibits walking/exercise ability.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03480581
| Contact: Judith M. Burnfield, Ph.D. | 402-413-4505 | jburnfield@madonna.org | |
| Contact: Guilherme M. Cesar, Ph.D. | 402-413-4503 | gcesar@madonna.org |
| United States, Nebraska | |
| Madonna Rehabilitation Hospital | Recruiting |
| Lincoln, Nebraska, United States, 68506 | |
| Contact: Judith M. Burnfield, Ph.D. 402-413-4505 jburnfield@madonna.org | |
| Contact: Katie Graf, B.A. 402-413-4781 kgraf@madonna.org | |
| Principal Investigator: | Judith M. Burnfield, Ph.D. | Madonna Rehabilitation Hospital |
| Responsible Party: | Judith M. Burnfield, PhD, PT, Director, Institute for Rehabilitation Science and Engineering, Madonna Rehabilitation Hospital |
| ClinicalTrials.gov Identifier: | NCT03480581 |
| Other Study ID Numbers: |
18-001-FB |
| First Posted: | March 29, 2018 Key Record Dates |
| Last Update Posted: | February 17, 2020 |
| Last Verified: | February 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | There is no plan for sharing IPD. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Neurological Gait Cardiorespiratory fitness Rehabilitation |
Walking Locomotor training Robotics |
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Nervous System Diseases Trauma, Nervous System Wounds and Injuries |