Impact of Reverse vs. Forward ICARE Training Interventions

Neurological Injury Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03480581
• Other study ID #: 18-001-FB
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: July 1, 2024

Study information

• Verified date: August 2023
• Source: Madonna Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 13
• Est. completion date: July 1, 2024
• Est. primary completion date: July 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nervous System Diseases
• Neurological Diseases or Conditions
• Neurological Injury
• Trauma, Nervous System

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Madonna Rehabilitation Hospital	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Madonna Rehabilitation Hospital

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. — View 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. — View 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. — View 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. — View 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.

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. — View 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.

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.

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.

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. — View 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.

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.

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	10 Meter Walk Test Speed	Average walking speed while traversing 10 meters	10 minutes
Primary	Peak Oxygen Consumption	This test of aerobic capacity quantifies the peak oxygen consumed while walking on a treadmill or rotating a crank ergometer	Up to 30 minutes
Secondary	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.	Up to 2 minute explanation followed by 6 minute formal walk test
Secondary	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.	Up to 30 minutes
Secondary	Cardiorespiratory Response During Treadmill Walking	Ratings of perceived effort during graded exercise test	Up to 30 minutes
Secondary	Cardiorespiratory Response During ICARE Training	Ratings of perceived effort while training on the ICARE	Up to 50 minutes
Secondary	Spatiotemporal Gait Measures	Stride characteristics (e.g., cadence, stride length, single limb support time) recorded while traversing instrumented walkway	20 minutes
Secondary	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.	8 minutes