Feasibility and Safety of a Portable Exoskeleton to Improve Mobility in Parkinson's Disease

Physical therapy approaches for balance and walking deficits in Parkinson's disease (PD) have limited effectiveness, with mostly short-lasting benefits. An exoskeleton is a device that straps to the legs and provides a passive force to assist people to better ambulate. The goal of this study is to establish the feasibility and safety of a lightweight exoskeleton on mobility and fall reduction in people with PD. As most PD patients eventually require assistive mobility devices, the exoskeleton represents a new option for increased, mobility, quality of life, and independence. Qualified subjects will come to the clinic twice weekly for six weeks (12 total visits) and wear the exoskeleton device while walking under the supervision of a trained physical therapist. Study staff will also interview participants and assess their PD symptoms, quality of life, and overall mobility. This study hopes to establish exoskeletons as modern, standard of care devices, which allow people with PD to maintain more independent and productive lives.

Study Overview

• Status: Not yet recruiting
• Conditions: Parkinson's Disease
• Intervention / Treatment: Device: Exoskeleton

Detailed Description

Currently, progressive resistance exercise training, high intensity treadmill training, balanced-based perturbation, and standard physical exercises are utilized to treat mobility deficits associated with PD; however, the effectiveness of these therapies is limited. This study proposes to investigate the utility of a portable exoskeleton for people with PD. The goal is to establish the safety of a lightweight portable exoskeleton, the Keeogo, for gait training and to preliminarily assess its potential efficacy for gait mobility and fall reduction. As the vast majority of PD patients eventually require assistive mobility devices, portable exoskeletons represents an avenue for increased, mobility, quality of life, and independence. Robotic-assist gait training (RAGT) has been extensively applied as a remarkable therapeutic modality, such that it is enabling highly motivated people with devastating neurologic injuries to regain independent ambulation. Despite the potential for this technology to transform the lives of people with PD, these devices are not being adequately investigated in people with movement disorders.

To establish preliminary safety and efficiency of the Keeogo exoskeleton for PD patients at various disease stages, the investigators will examine representative subjects in Hohen & Yahr stages II, III, IV, and V. Inclusion criteria are: 1) PD confirmed by a PADRECC movement disorder specialist using UK Brain Bank Criteria, 2) Modified H&Y stage II-V. Exclusion criteria are: 1) neurological, musculoskeletal, or other disorders unrelated to PD contributing to impairment of stance, gait, balance or coordination, 2) severe CHF, COPD, or those requiring nasal canula O2, 3) history of implantable cardiac device or ablative surgery, 4) moderate to severe cognitive impairment / dementia (Montreal Cognitive Assessment < 17/30), 5) symptomatic orthostatic hypotension with exertion, 6) feeding tube or associated port placement (PEG/J-PEG), 7) body height less than 5'1" or greater than 6'3" 8) body weight greater than 250 pounds, and 9) amputation of any portion of the lower limbs. Subjects will participate in a total of 30 minutes RAGT ambulation with the Keeogo twice per week for 6 weeks (12 sessions). Subjects may opt to utilize a platform rolling walker, rolling walker, bilateral Lofstrand crutches or a unilateral device, such as a cane or Lofstrand crutch, and will be maintained throughout the intervention.

To establish safety, the number and severity of AEs, such as falls, discomfort, skin or musculoskeletal injury, and orthostatic hypotensive episodes will be documented. Intervention efficacy will be measured pre- and post-donning of the Keeogo exoskeleton at bi-weekly intervention visits, and at a 6-week post-study visit. Walking capacity, including benefits on FoG, will be assessed with the Six Minute Walk Test (6MWT), balance and postural stability with the Berg Balance Scale (BBS), and disease severity with the Examination, Part III, of the Unified Parkinson's Disease Rating Scale (UPDRS). Additional assessments will include Berg Balance Scale (BBS), ascending and descending stair climb, PDQ39, The University of Alabama at Birmingham (UAB) Study of Aging Life-Space Assessment (LSA), and PD-Carer. As a primary end point for establishing efficacy, the 6MWT will be compared between end of training and baseline (with and without the exoskeleton), as well as at 6 and 12 weeks post-study as a durability assessment towards establishing a need for future assessment of in-home usage. These pilot investigations are expected to lay the groundwork for a large multi-center clinical study to establish ground exoskeletons as modern, standard of care devices to aid Veterans and other people with PD and other disabling movement disorders to maintain a more normal and productive life.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rachel Sinclair, MPHA; Phone Number: (804) 675-5931; Email: rachel.sinclair@va.gov
• Study Contact Backup: Name: Mark S Baron, MD; Phone Number: (804) 675-6700; Email: mark.baron@va.gov

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23249-0001
      • Hunter Holmes McGuire VA Medical Center, Richmond, VA
      • Contact: Alyssa Huizar; Phone Number: (804) 675-5151; Email: alyssa.huizar@va.gov
      • Principal Investigator: Mark S Baron, MD
      • Contact: Katrina Stumpf, MS; Phone Number: 3720 804-675-5000; Email: katrina.stumpf@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• PD confirmed by a PADRECC movement disorder specialist using UK Brain Bank Criteria
• Modified H&Y stage II-V

Exclusion Criteria:

• neurological, musculoskeletal, or other disorders unrelated to PD contributing to impairment of stance, gait, balance or coordination
• severe CHF, COPD, or those requiring nasal canula O2
• history of implantable cardiac device or ablative surgery
• moderately-severe to severe cognitive impairment / dementia (Montreal Cognitive Assessment < 17/30)
• symptomatic orthostatic hypotension with exertion
• feeding tube or associated port placement (PEG/J-PEG)
• body height less than 5'1" or greater than 6'3"
• body weight greater than 250 pounds
• amputation of any portion of the lower limbs
• osteoporosis as defined by DEXA Scan T score < -2.5
• failure to meet B-Temia-established hip and knee flexion and extension manual muscle test (MMT) prerequisite screening parameters, which assure that individuals can adequately engage and walk against the resistive forces of the Keeogo
• inability to complete 20 minutes of walking with the exoskeleton (over a maximum period of one hour) at the initial screening/testing session

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Feasibility and Safety; This is a feasibility study to assess the safety and potential utility of a lightweight ground exoskeleton (Keeogo, B-Temia, Inc.) to enhance mobility in people with Parkinson's disease (PD).	Device: Exoskeleton; lightweight ground exoskeleton; Other Names: Keeogo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Falls While Wearing the Exoskeleton (Safety and Tolerability) Change	Patients will be continuously supervised by a trained physical therapist and the expectation is that there will be no falls while wearing the device. All primary safety and tolerability measures will be separately assessed with consideration of H&Y staging (2-4; max. 5) and cognition (based on MOCA scores 0 = nl, max. 30). -Minimal attrition rate based on subjects being unable to complete the protocol. This could for example establish that the Keeogo device is not tolerated by more advanced (H&Y Stage 5) patients, but is acceptable for others.	Through last training visit (weeks 1-6, 12 sessions)
Incidence of Attrition (Tolerability) Change	The expectation is that there will be minimal attrition rate based on subjects being unable to complete the protocol. In the case of attrition, patients will be interviewed for contributory sources.	Through last training visit (weeks 1-6, 12 sessions)
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) Change	Patients will be questioned at the beginning of each session about potential AEs and any AEs observed during sessions by the therapists will be recorded at each training session. The expectation is that there will be no uncorrected and unacceptable AEs as captured by regular structured interviews.	through last training visit (weeks 1-6, 12 sessions)
Six-minute Walk Test (Suitability as a Future Primary Efficacy Measure) Change	The suitability of the 6MWT as a future primary clinical outcome measure (and our secondary measures) will be determined from the therapists' impression of ease and reliability of usage and from anticipated trends in scoring improvement. The outcomes here from the 6MWT and secondary measures will be further used towards powering for a future clinical efficacy study, while accounting for preliminary defined influences of severity of PD (H&Y Staging) and cognition (MOCA scoring). Additionally, 6- and 12-weeks post-training assessments will be used to preliminarily assess the durability of training effects.	through last training visit (weeks 1-6, 12 sessions) and 6- and 12-wks post-training
Patient Satisfaction	All subjects will be interviewed for patient satisfaction with wearing and training with the exoskeleton.	immediate post-training

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor examination (Part III) of the modified Unified Parkinson's Disease Rating Scale (Suitability as a Future Secondary Efficacy Measure)	Will assess the suitability of the modified UPDRS Part III (nl = 0, max. 128) as a future secondary clinical outcome measure. Will be collected at baseline and end of training. Additionally, 6- and 12-weeks post-training assessments will be used to preliminarily assess the durability of training effects.	immediate post-training, 6- and 12-wks post-training
Berg Balance Scale (Suitability as a Future Secondary Efficacy Measure)	Will assess the suitability of BBS (0 (worst) to 56 (best)) as a future secondary clinical outcome measure, focused on balance. Additionally, 6- and 12-weeks post-training assessments will be used to preliminarily assess the durability of training effects.	immediate post-training, 6- and 12-wks post-training
Motion Detector Sensors (Suitability as a Future Secondary Efficacy Measure)	Lightweight motion sensors will be attached to the exoskeleton on each leg to assess their suitability as future objective secondary clinical outcome measures of such gait parameters, as freezing of gait. Will be collected at each training visit. Additionally, 6- and 12-weeks post-training assessments will be used to preliminarily assess the durability of training effects.	through last training visit (weeks 1-6, 12 sessions) and 6- and 12-wks post-training
The University of Alabama at Birmingham Study of Aging Life-Space Assessment (Suitability as a Future Secondary Efficacy Measure)	Will assess the suitability of The UAB Study of Aging LSA (0 (worst) to 120 (best)) as a future secondary clinical outcome measure, focused on functional mobility. Additionally, 6- and 12-weeks post-training assessments will be used to preliminarily assess the durability of training effects.	immediate post-training, 6- and 12-wks post-training

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Mark S Baron, MD, Hunter Holmes McGuire VA Medical Center, Richmond, VA

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 30, 2023
• First Submitted That Met QC Criteria: September 5, 2023
• First Posted (Actual): September 8, 2023

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: exoskeleton
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: N4387-P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No