Impact of Reverse vs. Forward ICARE Training Interventions

August 11, 2023 updated by: Judith M. Burnfield, PhD, PT, Madonna Rehabilitation Hospital

Impact of Reverse vs. Forward ICARE Training Interventions on Walking and Fitness of Individuals With Walking Disorders Arising From Neurologic Injuries or Illnesses

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Madonna Rehabilitation Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Reverse First ICARE Training
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 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.
Experimental: Forward 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
10 Meter Walk Test Speed
Time Frame: 10 minutes
Average walking speed while traversing 10 meters
10 minutes
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
Up to 30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 2 minute explanation followed by 6 minute formal 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.
Up to 30 minutes
Cardiorespiratory Response During Treadmill Walking
Time Frame: Up to 30 minutes
Ratings of perceived effort during graded exercise test
Up to 30 minutes
Cardiorespiratory Response During ICARE Training
Time Frame: Up to 50 minutes
Ratings of perceived effort while training on the ICARE
Up to 50 minutes
Spatiotemporal Gait Measures
Time Frame: 20 minutes
Stride characteristics (e.g., cadence, stride length, single limb support time) recorded while traversing instrumented walkway
20 minutes
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.
8 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Madonna Rehabilitation Hospital

Investigators

  • Principal Investigator: Judith M. Burnfield, Ph.D., Madonna Rehabilitation Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

July 19, 2023

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

March 7, 2018

First Submitted That Met QC Criteria

March 27, 2018

First Posted (Actual)

March 29, 2018

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 11, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-001-FB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan for sharing IPD.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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