G-EO Gait Rehabilitation Training in Progressive Multiple Sclerosis

Not Applicable

Completed

• Conditions: Progressive Multiple Sclerosis
• Interventions: Other: Conventional Physical Therapy

• Registration Number: NCT03980145
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-05-02
• Study First Submitted: 2019-02-26
• Study First Submitted QC: 2019-06-07
• Study First Posted: 2019-06-10
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-01
• Disposition First Submitted: 2021-03-15
• Results First Submitted: 2021-04-30
• Status Verified: 2022-01
• Results First Submitted QC: 2022-01-20
• Disposition First Submitted QC: 2022-01-20
• Last Update Submitted: 2022-01-20
• Results First Posted: 2022-02-14
• Disposition First Posted: 2022-02-14
• Last Update Posted: 2022-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Physical Therapy	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.

Primary Outcome Measures

Name	Time	Method
Fast Walking Speed	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.	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.
Two Minute Walk Test	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.	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.
Multiple Sclerosis Impact Scale-29	Subjects perception of the their disability will be assessed prior to the start of the treatment and following study completion (at 10 weeks)	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.
Comfortable Walking Speed	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)	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.
Modified Fatigue Impact Scale	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 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.

Secondary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression Scale (HADS)	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 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.
Late-Life Function Inventory	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. The lowest score would be 0 and the highest scale score would be 100.
Short Form McGill Pain Questionnaire	Subjects perception of the their pain will be assessed prior to the start of the treatment and following study completion (at 10 weeks)	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 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. 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.

Trial Locations

Locations (1)

Neurorehabilitation and Robotics at IU Health Neuroscience Center; 🇺🇸 Indianapolis, Indiana, United States