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Impact of Reverse vs. Forward ICARE Training Interventions

Primary Purpose

Neurological Injury, Neurological Diseases or Conditions

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Forward First ICARE Training
Reverse First ICARE Training
Sponsored by
Madonna Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurological Injury focused on measuring Neurological, Gait, Cardiorespiratory fitness, Rehabilitation, Walking, Locomotor training, Robotics

Eligibility Criteria

7 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Madonna Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Reverse First ICARE Training

Forward First ICARE Training

Arm Description

Participants will engage in 12-sessions in the reverse direction followed by 12-sessions in the forward direction.

Participants will engage in 12-sessions in the forward direction followed by 12-sessions in the reverse direction.

Outcomes

Primary Outcome Measures

10 Meter Walk Test Speed
Average walking speed while traversing 10 meters
Peak Oxygen Consumption
This test of aerobic capacity quantifies the peak oxygen consumed while walking on a treadmill or rotating a crank ergometer

Secondary Outcome Measures

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.
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.
Cardiorespiratory Response During Treadmill Walking
Ratings of perceived effort during graded exercise test
Cardiorespiratory Response During ICARE Training
Ratings of perceived effort while training on the ICARE
Spatiotemporal Gait Measures
Stride characteristics (e.g., cadence, stride length, single limb support time) recorded while traversing instrumented walkway
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.

Full Information

First Posted
March 7, 2018
Last Updated
August 11, 2023
Sponsor
Madonna Rehabilitation Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03480581
Brief Title
Impact of Reverse vs. Forward ICARE Training Interventions
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
July 19, 2023 (Actual)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Madonna Rehabilitation Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurological Injury, Neurological Diseases or Conditions
Keywords
Neurological, Gait, Cardiorespiratory fitness, Rehabilitation, Walking, Locomotor training, Robotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reverse First ICARE Training
Arm Type
Experimental
Arm Description
Participants will engage in 12-sessions in the reverse direction followed by 12-sessions in the forward direction.
Arm Title
Forward First ICARE Training
Arm Type
Experimental
Arm Description
Participants will engage in 12-sessions in the forward direction followed by 12-sessions in the reverse direction.
Intervention Type
Behavioral
Intervention Name(s)
Forward First ICARE Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Reverse First ICARE Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
10 Meter Walk Test Speed
Description
Average walking speed while traversing 10 meters
Time Frame
10 minutes
Title
Peak Oxygen Consumption
Description
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
Secondary Outcome Measure Information:
Title
6 Minute Walk Test
Description
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
Title
Energy Cost of Treadmill Walking
Description
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
Title
Cardiorespiratory Response During Treadmill Walking
Description
Ratings of perceived effort during graded exercise test
Time Frame
Up to 30 minutes
Title
Cardiorespiratory Response During ICARE Training
Description
Ratings of perceived effort while training on the ICARE
Time Frame
Up to 50 minutes
Title
Spatiotemporal Gait Measures
Description
Stride characteristics (e.g., cadence, stride length, single limb support time) recorded while traversing instrumented walkway
Time Frame
20 minutes
Title
Timed Up and Go (TUG) Test
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith M. Burnfield, Ph.D.
Organizational Affiliation
Madonna Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Madonna Rehabilitation Hospital
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan for sharing IPD.
Citations:
PubMed Identifier
21885449
Citation
Burnfield JM, Shu Y, Buster TW, Taylor AP, Nelson CA. Impact of elliptical trainer ergonomic modifications on perceptions of safety, comfort, workout, and usability for people with physical disabilities and chronic conditions. Phys Ther. 2011 Nov;91(11):1604-17. doi: 10.2522/ptj.20100332. Epub 2011 Sep 1.
Results Reference
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PubMed Identifier
20022994
Citation
Burnfield JM, Shu Y, Buster T, Taylor A. Similarity of joint kinematics and muscle demands between elliptical training and walking: implications for practice. Phys Ther. 2010 Feb;90(2):289-305. doi: 10.2522/ptj.20090033. Epub 2009 Dec 18.
Results Reference
background
PubMed Identifier
27810692
Citation
Burnfield JM, Cesar GM, Buster TW, Irons SL, Nelson CA. Kinematic and muscle demand similarities between motor-assisted elliptical training and walking: Implications for pediatric gait rehabilitation. Gait Posture. 2017 Jan;51:194-200. doi: 10.1016/j.gaitpost.2016.10.018. Epub 2016 Oct 24.
Results Reference
background
PubMed Identifier
23973354
Citation
Burnfield JM, Irons SL, Buster TW, Taylor AP, Hildner GA, Shu Y. Comparative analysis of speed's impact on muscle demands during partial body weight support motor-assisted elliptical training. Gait Posture. 2014;39(1):314-20. doi: 10.1016/j.gaitpost.2013.07.120. Epub 2013 Aug 3.
Results Reference
background
PubMed Identifier
24189335
Citation
Buster T, Burnfield J, Taylor AP, Stergiou N. Lower extremity kinematics during walking and elliptical training in individuals with and without traumatic brain injury. J Neurol Phys Ther. 2013 Dec;37(4):176-86. doi: 10.1097/NPT.0000000000000022.
Results Reference
background
PubMed Identifier
23370765
Citation
Kim SG, Ryu YU, Je HD, Jeong JH, Kim HD. Backward walking treadmill therapy can improve walking ability in children with spastic cerebral palsy: a pilot study. Int J Rehabil Res. 2013 Sep;36(3):246-52. doi: 10.1097/MRR.0b013e32835dd620.
Results Reference
background
PubMed Identifier
15859527
Citation
Yang YR, Yen JG, Wang RY, Yen LL, Lieu FK. Gait outcomes after additional backward walking training in patients with stroke: a randomized controlled trial. Clin Rehabil. 2005 May;19(3):264-73. doi: 10.1191/0269215505cr860oa.
Results Reference
background
Citation
Irons, S.L., et al., Novel motor-assisted elliptical training intervention improves Six-Minute Walk Test and oxygen cost for an individual with progressive supranuclear palsy. Cardiopulmonary Physical Therapy Journal, 2015. 26(2): p. 36-41.
Results Reference
background
Citation
Nelson, C.A., et al., Modified elliptical machine motor-drive design for assistive gait rehabilitation. Journal of Medical Devices, 2011. 5(June): p. 021001.1-7.
Results Reference
background
Citation
Nelson, C.A., et al., Modification of the Intelligently Controlled Assistive Rehabilitation Elliptical (ICARE) system for pediatric therapy. Published online, ASME Journal of Medical Devices. DOI: 10.1115/1.4030276., 2015.
Results Reference
background
Citation
Irons, S.L., et al., Individuals with multiple sclerosis improved walking endurance and decreased fatigue following motor-assisted elliptical training intervention [Abstract]. Archives of Physical Medicine and Rehabilitation, 2016. 97(10): p. e34.
Results Reference
background
Citation
Burnfield, J.M., et al., Pedi-ICARE training improves walking and endurance of child with cerebral palsy. Archives of Physical Medicine and Rehabilitation, 2016. 97(12): p. E19-E20.
Results Reference
background
Citation
Cesar, G.M., et al., Child with traumatic brain injury improved gait abilities following intervention with pediatric motor-assisted elliptical training: A case report. Journal of Neurologic Physical Therapy, 2017. 41(1): p. 84.
Results Reference
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Impact of Reverse vs. Forward ICARE Training Interventions

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