Clinical trial NCT03980145: G-EO Gait Rehabilitation Training in Progressive Multiple Sclerosis
Official title: G-EO Gait Rehabilitation Training in Progressive Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Progressive Multiple Sclerosis
Keywords: Robotics
Gait Training
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: University of Alabama at Birmingham
name: University of Ottawa
First posted: 2019-06-10
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Comfortable Walking Speed
timeFrame: 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)
measure: Two Minute Walk Test
timeFrame: 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.
measure: Modified Fatigue Impact Scale
timeFrame: Subjects perception of the their fatigue will be assessed prior to the start of the treatment and following study completion (at 10 weeks)
measure: Multiple Sclerosis Impact Scale-29
timeFrame: Subjects perception of the their disability will be assessed prior to the start of the treatment and following study completion (at 10 weeks)
measure: Fast Walking Speed
timeFrame: 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:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 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)
measure: Short Form McGill Pain Questionnaire
timeFrame: Subjects perception of the their pain will be assessed prior to the start of the treatment and following study completion (at 10 weeks)
measure: Late-Life Disability Inventory (LLFDI)
timeFrame: 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)
measure: Late-Life Function Inventory
timeFrame: 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)
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Neurorehabilitation and Robotics at IU Health Neuroscience Center
state: Indiana
Study officials:
affiliation: Indiana University
name: Peter Altenburger, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References: