Impact of Reverse vs. Forward ICARE Training Interventions

NCT03480581 | Unknown

• 1 other identifier: 18-001-FB
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurological Injury; Neurological Diseases or Conditions

Keywords

Neurological; Gait; Cardiorespiratory fitness; Rehabilitation; Walking; Locomotor training; Robotics

Outcome Measures

Primary Outcomes (2)

• 10 Meter Walk Test Speed

  Average walking speed while traversing 10 meters

  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

  Up to 30 minutes

Secondary Outcomes (6)

• 6 Minute Walk Test

  Up to 2 minute explanation followed by 6 minute formal walk test

• Energy Cost of Treadmill Walking

  Up to 30 minutes

• Cardiorespiratory Response During Treadmill Walking

  Up to 30 minutes

• Cardiorespiratory Response During ICARE Training

  Up to 50 minutes

• Spatiotemporal Gait Measures

  20 minutes

Study Arms (2)

Reverse First ICARE Training

EXPERIMENTAL

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

Behavioral: Reverse First ICARE Training

Forward First ICARE Training

EXPERIMENTAL

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

Behavioral: Forward First ICARE Training

Interventions

Forward First ICARE Training BEHAVIORAL

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.

Forward First ICARE Training

Reverse First ICARE Training BEHAVIORAL

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.

Reverse First ICARE Training

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Madonna Rehabilitation Hospital: lead

Study Sites (1)

Madonna Rehabilitation Hospital

Lincoln, Nebraska, 68506, United States

Location

Related Publications (13)

• 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.

  PMID: 21885449 BACKGROUND

• 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.

  PMID: 20022994 BACKGROUND

• 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.

  PMID: 27810692 BACKGROUND

• 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.

  PMID: 23973354 BACKGROUND

• 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.

  PMID: 24189335 BACKGROUND

• 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.

  PMID: 23370765 BACKGROUND

• 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.

  PMID: 15859527 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Trauma, Nervous System; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Nervous System Diseases; Wounds and Injuries; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Judith M. Burnfield, Ph.D.

  Madonna Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Institute for Rehabilitation Science and Engineering

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: March 29, 2018
• Study Start: June 1, 2018
• Primary Completion: July 19, 2023
• Study Completion: July 1, 2024
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)