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.