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

VA Office of Research and Development

Status: Enrolling

Conditions: Parkinson's Disease

Treatments: Device: Exoskeleton

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT06028529

N4387-P

Details and patient eligibility

About

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 eight weeks (16 total visits) and wear the exoskeleton device while walking under the supervision of a trained kinesiotherapist. 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.

Full 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, and IV. 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 8 weeks (16 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 3 post-study visits. Walking capacity, including benefits on FoG, will be assessed with the Six Minute Walk Test (6MWT), balance and postural stability with the MiniBest test, and disease severity with the Examination, Part III, of the Unified Parkinson's Disease Rating Scale (UPDRS). Additional assessments will include surveys about quality of life, activity, balance, and feedback on the device. 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• PD confirmed by a PADRECC movement disorder specialist using UK Brain Bank Criteria
• Modified H&Y stage II-V
• Veteran
• Able to attend visits at the Richmond VA Medical Center

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Feasibility and Safety

Other group

Description:

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).

Treatment:

Device: Exoskeleton