G-EO Gait Rehabilitation Training in Progressive Multiple Sclerosis

NCT03980145 | Completed Results FDA Device

• 1 other identifier: 1701909134
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Progressive Multiple Sclerosis

Keywords

Robotics; Gait Training

Outcome Measures

Primary Outcomes (5)

• 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.

  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)

• 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.

  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.

• 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.

  Subjects perception of the their fatigue will be assessed prior to the start of the treatment and following study completion (at 10 weeks)

• 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.

  Subjects perception of the their disability will be assessed prior to the start of the treatment and following study completion (at 10 weeks)

• 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.

  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 Outcomes (4)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

Conventional Physical Therapy

ACTIVE COMPARATOR

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

End-Effector Robotic Training

EXPERIMENTAL

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)

Interventions

G-EO System (Reha Technology AG: Olten, Switzerland) DEVICE

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.

Also known as: Electromechanically-assisted gait training, Robotic end-effector gait training system

End-Effector Robotic Training

Conventional Physical Therapy OTHER

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.

Conventional Physical Therapy

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Indiana University: lead
• University of Alabama at Birmingham: collaborator
• University of Ottawa: collaborator

Study Sites (1)

Neurorehabilitation and Robotics at IU Health Neuroscience Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Peter Altenburger
• Organization: Indiana University

paltenbu@iu.edu

3172780703

Study Officials

• Peter Altenburger, PhD, PT

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Health and Rehabilitation

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: June 10, 2019
• Study Start: May 2, 2017
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: February 14, 2022
• Results First Posted: February 14, 2022

Record last verified: 2022-01

Locations

US (1)