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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06028529
• Other study ID #: N4387-P
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 15, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: VA Office of Research and Development
• Contact: Rachel Sinclair, MPHA
• Phone: (804) 675-5931
• Email: rachel.sinclair[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• Exoskeleton
lightweight ground exoskeleton

Locations

Country	Name	City	State
United States	Hunter Holmes McGuire VA Medical Center, Richmond, VA	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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
Primary	Patient Satisfaction	All subjects will be interviewed for patient satisfaction with wearing and training with the exoskeleton.	immediate post-training
Secondary	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
Secondary	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
Secondary	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
Secondary	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