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G-EO Gait Rehabilitation Training in Progressive Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT03980145
Recruitment Status : Recruiting
First Posted : June 10, 2019
Last Update Posted : June 10, 2019
Sponsor:
Collaborators:
University of Alabama at Birmingham
University of Ottawa
Information provided by (Responsible Party):
Peter Altenburger, Indiana University

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.


Condition or disease Intervention/treatment Phase
Progressive Multiple Sclerosis Device: G-EO System (Reha Technology AG: Olten, Switzerland) Other: Conventional Physical Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: G-EO Gait Rehabilitation Training in Progressive Multiple Sclerosis
Actual Study Start Date : May 2, 2017
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Conventional Physical Therapy
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.
Other: Conventional Physical Therapy
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.

Experimental: End-Effector Robotic Training
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.
Device: G-EO System (Reha Technology AG: Olten, Switzerland)
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.
Other Names:
  • Electromechanically-assisted gait training
  • Robotic end-effector gait training system




Primary Outcome Measures :
  1. Change in Walking Speed [ Time Frame: Gait speed for comfortable and fast walking will be assessed prior to the start of the treatment, at 5 weeks, following study completion (at 10 weeks) ]
    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.Walking speed at a comfortable pace and fast pace will be reported.

  2. Change in Two minute walk test [ Time Frame: Walking distance will be assessed prior to the start of the treatment, at 5 weeks, following study completion (at 10 weeks) ]
    A 2-minute walk (2MWT) tests 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.

  3. Change in Modified Fatigue Impact Scale [ 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) ]
    Subjects will complete a questionnaire evaluating their level of perceived fatigue. The scale includes an overall score and three subscales: physical, cognitive, and psychosocial. Total scores range from 0 to 84 while the physical subscale ranges from 0 to 36; cognitive subscale from 0 to 40; and psychosocial subscale from 0 to 8. For the total score and subscales a higher scores indicates greater fatigue. Decreases in total ans subscale scores over time indicate decreases in feelings of fatigue. Total and subscales are summed.

  4. Change in Multiple Sclerosis Impact Scale-29 [ 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) ]

    Subjects will complete 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 daily function. There are two subscales: physical scale (20 items) and psychological (9 items). Score is achieved by summing the scores for each of the two subscales and then converting the score to a 100 point scale. On the 100 point scale, 0 would indicate no impact of the disease on daily function and 100 would indicate the greatest possible impact.

    Physical impact scale is calculated by subtracting the score from 20, multiplying by 100 and dividing by 80.

    Psychological impact scale is calculated by subtracting the score from 9, multiplying by 100 and dividing by 36



Secondary Outcome Measures :
  1. Change in Balance adaptation [ Time Frame: Postural adaptation will be assessed prior to the start of the treatment, at 5 weeks, following study completion (at 10 weeks) ]
    Balance assessment using the Neurocom Balance Master. Subjects will be asked to stand on a balance platform while the load cells in the force-plate measures postural stability when challenged. The force-plate will move without warning allowing for assessment of patient postural adaptation.

  2. Change in Balance limits of stability [ Time Frame: Subject limits of stability will be assessed prior to the start of the treatment, at 5 weeks, following study completion (at 10 weeks) ]
    Balance assessment using the Neurocom Balance Master. Subjects will be asked to stand on a balance platform while the load cells in the force-plate measures postural stability. With this test, the subject will be asked to manipulate their center of mass toward an object to assess their ability to control their center of mass within their base of support.

  3. Hospital Anxiety and Depression Scale [ 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) ]
    Subjects will complete a questionnaire evaluating their level of anxiety and depression. The scale comprises 7 questions related to anxiety and 7 questions related to depression. The scores for each subscale are summed to provide a total score for anxiety and depression. The higher the score the greater the caseness of each factor. A score between 8-10 is consider mild, 11-14 is moderate, >14 is severe.

  4. Short Form McGill Pain Questionnaire [ 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) ]
    Subjects will complete a questionnaire evaluating their level of pain. There are 15 adjectives that describe the sensory (11 words) and affective (4 words) qualities of 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.

  5. Late-Life Disability Inventory [ 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) ]

    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. 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.


  6. Late-Life Function Inventory [ 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) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03980145


Contacts
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Contact: Peter A Altenburger, PhD, PT 3172780703 paltenbu@iu.edu

Locations
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United States, Indiana
Neurorehabilitation and Robotics at IU Health Neuroscience Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Ryan Cardinal, PhD, PT    317-963-7053    rcardin1@iuhealth.org   
Contact: Peter Altenburger, PhD, PT    3173105505    paltenbu@iu.edu   
Sponsors and Collaborators
Indiana University
University of Alabama at Birmingham
University of Ottawa
Investigators
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Principal Investigator: Peter Altenburger, PhD, PT Indiana University

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Responsible Party: Peter Altenburger, Associate Professor, Health and Rehabilitation, Indiana University
ClinicalTrials.gov Identifier: NCT03980145     History of Changes
Other Study ID Numbers: 1701909134
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Peter Altenburger, Indiana University:
Robotics
Gait Training
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases