Ignite Creation Date:
2024-05-06 @ 7:28 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06028529
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2023-05-30
Brief Title:
Feasibility and Safety of a Portable Exoskeleton to Improve Mobility in Parkinsons Disease
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Feasibility and Safety of a Portable Exoskeleton to Improve Mobility in Parkinsons Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Physical therapy approaches for balance and walking deficits in Parkinsons 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
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 HY 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 1730 5 symptomatic orthostatic hypotension with exertion 6 feeding tube or associated port placement PEGJ-PEG 7 body height less than 51 or greater than 63 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 Parkinsons 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
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 HY 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 1730 5 symptomatic orthostatic hypotension with exertion 6 feeding tube or associated port placement PEGJ-PEG 7 body height less than 51 or greater than 63 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 Parkinsons 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None