Clinical trial NCT05218187: Robotic Gait Rehabilitation in Parkinson's Disease
Official title: Robotic Gait Rehabilitation in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Gait Disorder, Sensorimotor
Keywords: End-Effector Gait Training
Robot-Assisted Gait Training
Mobility
Function
Quality of Life
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2022-02-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A convenience sample of 30 persons with Parkinson's Disease will be enrolled for this clinical trial. If found eligible for the study and agree to consent to participate, subjects will be randomized to either conventional physical therapy (CPT) group or CPT with G-EO training using a random numbers generator and concealed allocation.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the implementation of a novel gait rehabilitation stimulus (G-EO System) that could advance current clinical practices. The goal is to establish the safety and feasibility of gait training using the G-EO System as well as investigating the impact on mobility, function, quality of life, and participatory outcomes.

Research Design: We propose a single-blinded, randomized trial of electromechanically-assisted gait training using the G-EO System in patients with Parkinson's disease with gait disability.

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, function, and quality of life

Detailed description: Individuals diagnosed with Parkinson's disease (PD) often suffer from difficulties with gait initiation, maintaining a consistent kinematic gait pattern, and transitions between gait environments. Focused gait training that provides an environment that can emphasize motor control improvement in these deficits would be ideal for building a rehabilitative foundation for gait recovery for individuals with PD.

One approach that has been used to maintain and restore function in other neurological populations with severe disability is gait rehabilitation using treadmill training. This approach allows for specific and repetitive practice of walking movement and can involve therapist or electromechanical assistance. There is preliminary evidence from two small, uncontrolled studies supporting the benefits of therapist-assisted treadmill training on walking, balance, fatigue, spasticity, muscle strength, and quality of life in patients with PPMS and SPMS. Nevertheless, therapist-assisted gait training can require up to three trainers per patient making it burdensome and inefficient in the clinical setting. The intensity of manual treadmill training is low (i.e., \<1.5 METs) based in part on the physical capacity and fitness level of the trainers, yet physiological adaptations for optimizing outcomes require moderate or vigorous intensity exercise.

Robotic-assisted gait training (RAGT) 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. The G-EO System (Reha Technology AG: Olten, Switzerland) is a novel end-effector robotic 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. Gait training using the G-EO System has been applied in patients with stroke, Multiple Sclerosis (MS), and cerebral palsy (CP). These studies have established safety and feasibility, and preliminary evidence for benefits on mobility and function. For example, two studies involving 4 weeks of G-EO training with conventional physical therapy in non-ambulatory subacute stroke patients reported improved gait, stair climbing ability, leg strength, and activities of daily living (ADL) compared to physical therapy alone. There is limited RAGT studies evaluating the impact of this type of training for individuals with PD. The potential focus on improved gait kinematics may be of particular benefit for PD patients who often struggle with maintain step length and initiation.

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 an effective rehabilitation tool for restoring and maintaining function in Parkinson's disease. This approach represents an opportunity for improving current clinical practices for patients with Parkinson's disease. 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.

The purpose of this study is to investigate the implementation of a novel gait rehabilitation stimulus (G-EO System) that could advance current clinical practices. The goal is to establish the safety and feasibility of gait training using the G-EO System as well as investigating the impact on mobility, function, quality of life, and participatory outcomes.

Research Design: We propose a single-blinded, randomized trial of electromechanically-assisted gait training using the G-EO System in patients with Parkinson's disease with gait disability.

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, function, and quality of life.

Eligibility criteria: Inclusion Criteria:

* Age \> 18years
* Confirmed diagnosis of Parkinson's Disease
* Hoehn and Yahr stage 1 to 3
* Stable course of disease-modifying therapy over the past 3 months
* Mini Mental State Examination \> 24
* Physician approval for exercise
* Stable deep brain stimulation setting for the past year
* Demonstrate a need for functional rehabilitation

Exclusion Criteria:

* • Severe dyskinesia or severe on-off phenomenon

  * Unstable medication regiment
  * Any co-morbidity that will interfere with walking
  * 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 (CWS)
timeFrame: It will take 5 minutes to complete this test and will be performed first
measure: Fast Walking Speed (FWS)
timeFrame: It will take 5 minutes to complete this test and will be performed second
measure: Six Minute Walk Test (6MWT)
timeFrame: It will take 10 minutes to complete this test and will be performed third
Secondary outcomes:
measure: Six Minute Walk Test Walking Speed (6MWT)
timeFrame: It will take 10 minutes to complete this test. The speed metrics will be recorded while the primary 6MWT data is being captured.
measure: Mini BESTest
timeFrame: The test takes about 15 minutes to administer
measure: The Five Times Sit to Stand Test
timeFrame: This test will take about 5 minutes to administer
measure: Activities-Specific Balance Confidence Scale (ABC)
timeFrame: This survey will take about 10 minutes to complete
measure: Parkinson's disease Questionnaire-39 (PDQ39)
timeFrame: The survey will take about 20 minutes to complete
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: IU Health Neurorehabilitation and Robotics
state: Indiana
Study officials:
References: