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G-EO Gait Rehabilitation Training in Progressive Multiple Sclerosis

Primary Purpose

Progressive Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
G-EO System (Reha Technology AG: Olten, Switzerland)
Conventional Physical Therapy
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Progressive Multiple Sclerosis focused on measuring Robotics, Gait Training

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18-64 years
  • Confirmed diagnosis of Primary or Secondary Progressive Multiple Sclerosis (this will be confirmed by the referring physician)
  • EDSS 4.0-7.522
  • Stable course of disease-modifying therapy over the past 6 months
  • Asymptomatic (i.e., no underlying cardiovascular disease)
  • Physician approval for exercise
  • Willingness to visit the IU Health Neurosciences Center for testing and training

Exclusion Criteria:

  • Pregnancy
  • Current use of dalfampridine (Ampyra®)
  • Conventional physical therapy or G-EO training within the past 6 months
  • Height <1m or >2m
  • Body weight >150 kg
  • Contraindications to G-EO gait training (e.g., bone instability)

Sites / Locations

  • Neurorehabilitation and Robotics at IU Health Neuroscience Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional Physical Therapy

End-Effector Robotic Training

Arm Description

Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training.40-43 Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided.

G-EO training: Using the G-EO System, participants will be secured with the appropriate sized harness and attached to an overhead body-weight support system, with feet secured to pressure sensitive footplates. Each session will begin with a 3-5 minute warm-up in the continuous passive mode (cadence ~40-45 steps/minute). The participant will then be transitioned into the adaptive training phase for practicing repetitive floor walking and stair climbing for up to 30 minutes. During this phase, the force produced by the robot is modulated to support the effort of the patient in producing a typical walking pattern.

Outcomes

Primary Outcome Measures

Comfortable Walking Speed
Comfortable Walking speed will be assessed using a Pressure Sensor Walkway. Participants will be asked to walk over a 14 foot pressure mat that will capture their walking speed. Scores range from 0 (no speed) to as fast as they are comfortable with the most common range being .1 to 1.5 meters per second.
Two Minute Walk Test
A 2-minute walk (2MWT) test to determine walking endurance. Subjects will be asked to walk for 2 minutes along a 30m track. Subjects may stop and rest as often as needed. The outcome is the distance in meters traveled during the 2 minutes. Scores can range from 0 to 500 meters. An increase in distance following treatment when compared to pretest numbers would indicate improved muscular and cardiovascular endurance.
Modified Fatigue Impact Scale
Subjects will complete a questionnaire evaluating their level of perceived fatigue. The scores are divided into three different scales: physical, cognitive, and psychosocial. A total score is also calculated. Scale scores are represented by the following ranges: physical subscale ranges from 0 to 36; cognitive subscale from 0 to 40; and psychosocial subscale from 0 to 8. A total score has a range of 0 to 85. A higher score indicates greater fatigue. Decreases in scores over time indicate decreases in feelings of fatigue. Each scale including the total score is summed.
Multiple Sclerosis Impact Scale-29
Subjects completed a 29 item questionnaire evaluating their level of health-related quality of life. The higher the score the greater the impact MS is having on their daily function. The 29 items are divided into a 20 item physical scale and 9 item psychological scale. Each item has four potential responses resulting in scores on the physical impact scale ranging from 20 to 80 and on the psychological impact scale ranging from 9 to 36. Final scores for each scale are achieved by summing the items for each of the two scales and then transforming them to a 100 point scale for easy comparison. On the 100 point scale, 0 would indicate no impact of the disease on daily function and 100 would indicate the greatest possible impact.
Fast Walking Speed
Fast Walking speed will be assessed using a Pressure Sensor Walkway. Participants will be asked to walk over a 14 foot pressure mat that will capture their walking speed. Scores range from 0 (no speed) to as fast as they are able with the most common range being .5 to 2.0 meters per second.

Secondary Outcome Measures

Hospital Anxiety and Depression Scale (HADS)
Subjects completed a questionnaire evaluating their level of anxiety and depression. The questionnaire is comprised of two scales: a 7 item scale related to anxiety and 7 item scale related to depression. Each item within both scales is scored using a 0-3 scoring system depending upon the individual's answer. Both the anxiety scale and the depression scale can range in scores from 0 to 21. Although the 14 items were administered together, each set of seven questions was kept separate and scored separately to create a score for anxiety and one for depression. The scores for each scale were summed to provide a total score for anxiety and a separate score for depression. The higher the score the greater the severity. A score between 8-10 is consider mild, 11-14 is moderate, >14 is severe for both scales.
Short Form McGill Pain Questionnaire
Subjects completed a questionnaire evaluating their level of pain. There are 15 adjectives that describe the patient's pain. The patient ranks each of the words on a categoric scale of "none, mild, moderate, severe. Sensory and affective scores will be computed separately. Scores are created from a summary of the responses using an intensity scale of 0 = none, 1 = mild, 2 = moderate and 3 = severe. The higher the score the more severe the pain is for each of the subscales. For this study, sensory, affective, and total pain scores are reported. The minimum sensory, affective, and total score score would be zero. The maximum score for sensory is 33, affective is 12, and total is 45.
Late-Life Disability Inventory (LLFDI)
Subjects will complete a questionnaire evaluating their perceived level of disability. This tool assesses and responds to meaningful change in a persons disability (Ability to participate in life's activities). There is a 16 item disability component that is scored across two dimensions: frequency and limitation. Total scores and dimensional scores are created by summation and conversion to a 100 point scaled score. The instrument provides a table for converting the raw score to a scaled score. The lowest possible scale score is 0 and the highest score is 100 for both frequency and limitation. A higher score indicates greater functional ability and less disability. Each dimension can be further assessed by analyzing domains. There are social and personal domains within the frequency dimension and instrumental and management domains within the limitations dimension. All domains are calculated as described before through summation and scale adjustment.
Late-Life Function Inventory
Subjects will complete a questionnaire evaluating their perceived level of function. This tool assesses and responds to meaningful change in a persons function (ability to execute discrete tasks). There is a 32 item functional component is comprised of three domains Upper Extremity, Basic Lower Extremity, Advanced Lower Extremity. Total score and each domain will be scored by summing and then converting to a 100 point scaled score. The instrument provides a table for converting the raw score to a scaled score. A higher score indicates greater functional ability. The lowest score would be 0 and the highest scale score would be 100.

Full Information

First Posted
February 26, 2019
Last Updated
January 20, 2022
Sponsor
Indiana University
Collaborators
University of Alabama at Birmingham, University of Ottawa
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1. Study Identification

Unique Protocol Identification Number
NCT03980145
Brief Title
G-EO Gait Rehabilitation Training in Progressive Multiple Sclerosis
Official Title
G-EO Gait Rehabilitation Training in Progressive Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
May 2, 2017 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
University of Alabama at Birmingham, University of Ottawa

4. Oversight

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

5. Study Description

Brief Summary
The logistic advantages and advanced training capabilities of the G-EO System, as well as the benefits reported in other populations, support this strategy as a potentially potent rehabilitation tool for restoring and maintaining function in progressive Multiple Sclerosis (MS). This approach represents a paradigm shifting opportunity for improving current clinical practices for patients with progressive MS. If successful, this project will provide initial evidence for increasing patient access to the G-EO System, and this could be accomplished through "regional technology centers" using a rural health-delivery approach. There are several novel aspects of the proposed trial: (1) the examination of a novel gait rehabilitation stimulus (G-EO System) that could alter current clinical practices; (2) the focus on patients with progressive MS who have gait impairment (i.e., those who have received minimal research attention), which was recently described as the greatest therapeutic challenge facing the MS community; and (3) a study design that accounts for standard therapy. Specific Aims: The investigators designed a single-blinded, randomized pilot trial of electromechanically-assisted gait training using the G-EO System in patients with progressive MS with gait disability (EDSS=4.0-7.5). Specific Aim 1 will establish the safety and feasibility of gait training using the G-EO System. Specific Aim 2 will determine the efficacy of gait training using the G-EO System for improving mobility, symptomatic, quality of life, and participatory outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Progressive Multiple Sclerosis
Keywords
Robotics, Gait Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional Physical Therapy
Arm Type
Active Comparator
Arm Description
Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training.40-43 Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided.
Arm Title
End-Effector Robotic Training
Arm Type
Experimental
Arm Description
G-EO training: Using the G-EO System, participants will be secured with the appropriate sized harness and attached to an overhead body-weight support system, with feet secured to pressure sensitive footplates. Each session will begin with a 3-5 minute warm-up in the continuous passive mode (cadence ~40-45 steps/minute). The participant will then be transitioned into the adaptive training phase for practicing repetitive floor walking and stair climbing for up to 30 minutes. During this phase, the force produced by the robot is modulated to support the effort of the patient in producing a typical walking pattern.
Intervention Type
Device
Intervention Name(s)
G-EO System (Reha Technology AG: Olten, Switzerland)
Other Intervention Name(s)
Electromechanically-assisted gait training, Robotic end-effector gait training system
Intervention Description
Electromechanically-assisted gait training addresses many of the limitations of therapist-assisted gait training and can be performed using either exoskeleton or end-effector devices. Exoskeleton devices involve programmable drives or passive elements which physically move the lower limbs, whereas, end-effector approaches involve driven footplates that have trajectories that simulate the stance and swing phases.13,14 The G-EO System (Reha Technology: Olten, Switzerland) is a novel end-effector gait training system that was developed for regaining mobility and independence in stroke survivors. This system involves minimal therapist and patient burden (e.g., quick set-up, single operate usage), there is the unique capacity for practicing walking and stair climbing movements, and the patient can receive real-time visual feedback.
Intervention Type
Other
Intervention Name(s)
Conventional Physical Therapy
Intervention Description
Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training. Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided.
Primary Outcome Measure Information:
Title
Comfortable Walking Speed
Description
Comfortable Walking speed will be assessed using a Pressure Sensor Walkway. Participants will be asked to walk over a 14 foot pressure mat that will capture their walking speed. Scores range from 0 (no speed) to as fast as they are comfortable with the most common range being .1 to 1.5 meters per second.
Time Frame
Gait speed for comfortable walking will be assessed prior to the start of the treatment (Pretest) and following study completion which occurred following 20 treatment visits (Posttest)
Title
Two Minute Walk Test
Description
A 2-minute walk (2MWT) test to determine walking endurance. Subjects will be asked to walk for 2 minutes along a 30m track. Subjects may stop and rest as often as needed. The outcome is the distance in meters traveled during the 2 minutes. Scores can range from 0 to 500 meters. An increase in distance following treatment when compared to pretest numbers would indicate improved muscular and cardiovascular endurance.
Time Frame
Walking distance will be assessed prior to the start of the treatment (Pretest) and following study completion (Posttest). Pretest represents a time point prior to intervention training. Posttest represents the point following intervention completion.
Title
Modified Fatigue Impact Scale
Description
Subjects will complete a questionnaire evaluating their level of perceived fatigue. The scores are divided into three different scales: physical, cognitive, and psychosocial. A total score is also calculated. Scale scores are represented by the following ranges: physical subscale ranges from 0 to 36; cognitive subscale from 0 to 40; and psychosocial subscale from 0 to 8. A total score has a range of 0 to 85. A higher score indicates greater fatigue. Decreases in scores over time indicate decreases in feelings of fatigue. Each scale including the total score is summed.
Time Frame
Subjects perception of the their fatigue will be assessed prior to the start of the treatment and following study completion (at 10 weeks)
Title
Multiple Sclerosis Impact Scale-29
Description
Subjects completed a 29 item questionnaire evaluating their level of health-related quality of life. The higher the score the greater the impact MS is having on their daily function. The 29 items are divided into a 20 item physical scale and 9 item psychological scale. Each item has four potential responses resulting in scores on the physical impact scale ranging from 20 to 80 and on the psychological impact scale ranging from 9 to 36. Final scores for each scale are achieved by summing the items for each of the two scales and then transforming them to a 100 point scale for easy comparison. On the 100 point scale, 0 would indicate no impact of the disease on daily function and 100 would indicate the greatest possible impact.
Time Frame
Subjects perception of the their disability will be assessed prior to the start of the treatment and following study completion (at 10 weeks)
Title
Fast Walking Speed
Description
Fast Walking speed will be assessed using a Pressure Sensor Walkway. Participants will be asked to walk over a 14 foot pressure mat that will capture their walking speed. Scores range from 0 (no speed) to as fast as they are able with the most common range being .5 to 2.0 meters per second.
Time Frame
Fast walking speed will be assessed prior to the start of the treatment (Pretest) and following study completion (Posttest). Pretest represents a time point prior to intervention training. Posttest represents the point following intervention completion.
Secondary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale (HADS)
Description
Subjects completed a questionnaire evaluating their level of anxiety and depression. The questionnaire is comprised of two scales: a 7 item scale related to anxiety and 7 item scale related to depression. Each item within both scales is scored using a 0-3 scoring system depending upon the individual's answer. Both the anxiety scale and the depression scale can range in scores from 0 to 21. Although the 14 items were administered together, each set of seven questions was kept separate and scored separately to create a score for anxiety and one for depression. The scores for each scale were summed to provide a total score for anxiety and a separate score for depression. The higher the score the greater the severity. A score between 8-10 is consider mild, 11-14 is moderate, >14 is severe for both scales.
Time Frame
Subjects perception of the their anxiety and depression will be assessed prior to the start of the treatment and following study completion (at 10 weeks)
Title
Short Form McGill Pain Questionnaire
Description
Subjects completed a questionnaire evaluating their level of pain. There are 15 adjectives that describe the patient's pain. The patient ranks each of the words on a categoric scale of "none, mild, moderate, severe. Sensory and affective scores will be computed separately. Scores are created from a summary of the responses using an intensity scale of 0 = none, 1 = mild, 2 = moderate and 3 = severe. The higher the score the more severe the pain is for each of the subscales. For this study, sensory, affective, and total pain scores are reported. The minimum sensory, affective, and total score score would be zero. The maximum score for sensory is 33, affective is 12, and total is 45.
Time Frame
Subjects perception of the their pain will be assessed prior to the start of the treatment and following study completion (at 10 weeks)
Title
Late-Life Disability Inventory (LLFDI)
Description
Subjects will complete a questionnaire evaluating their perceived level of disability. This tool assesses and responds to meaningful change in a persons disability (Ability to participate in life's activities). There is a 16 item disability component that is scored across two dimensions: frequency and limitation. Total scores and dimensional scores are created by summation and conversion to a 100 point scaled score. The instrument provides a table for converting the raw score to a scaled score. The lowest possible scale score is 0 and the highest score is 100 for both frequency and limitation. A higher score indicates greater functional ability and less disability. Each dimension can be further assessed by analyzing domains. There are social and personal domains within the frequency dimension and instrumental and management domains within the limitations dimension. All domains are calculated as described before through summation and scale adjustment.
Time Frame
Subjects perception of the their functional ability using the total score and dimensional scores will be assessed prior to the start of the treatment and following study completion (at 10 weeks)
Title
Late-Life Function Inventory
Description
Subjects will complete a questionnaire evaluating their perceived level of function. This tool assesses and responds to meaningful change in a persons function (ability to execute discrete tasks). There is a 32 item functional component is comprised of three domains Upper Extremity, Basic Lower Extremity, Advanced Lower Extremity. Total score and each domain will be scored by summing and then converting to a 100 point scaled score. The instrument provides a table for converting the raw score to a scaled score. A higher score indicates greater functional ability. The lowest score would be 0 and the highest scale score would be 100.
Time Frame
Subjects perception of the their functional ability using all three domains will be assessed prior to the start of the treatment and following study completion (at 10 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-64 years Confirmed diagnosis of Primary or Secondary Progressive Multiple Sclerosis (this will be confirmed by the referring physician) EDSS 4.0-7.522 Stable course of disease-modifying therapy over the past 6 months Asymptomatic (i.e., no underlying cardiovascular disease) Physician approval for exercise Willingness to visit the IU Health Neurosciences Center for testing and training Exclusion Criteria: Pregnancy Current use of dalfampridine (Ampyra®) Conventional physical therapy or G-EO training within the past 6 months Height <1m or >2m Body weight >150 kg Contraindications to G-EO gait training (e.g., bone instability)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Altenburger, PhD, PT
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neurorehabilitation and Robotics at IU Health Neuroscience Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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G-EO Gait Rehabilitation Training in Progressive Multiple Sclerosis

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