RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-09-01
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06028529

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * PD confirmed by a PADRECC movement disorder specialist using UK Brain Bank Criteria
  2. * Modified H\&Y stage II-V
  3. * Veteran
  4. * Able to attend visits at the Richmond VA Medical Center
  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. * moderately-severe 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
  9. * amputation of any portion of the lower limbs
  10. * osteoporosis as defined by DEXA Scan T score \< -2.5
  11. * 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
  12. * inability to complete 20 minutes of walking with the exoskeleton (over a maximum period of one hour) at the initial screening/testing session

Contacts and Locations

Study Contact

Rachel G Sinclair, MPHA
CONTACT
(804) 675-5931
rachel.sinclair@va.gov
Jessica B Lehosit
CONTACT
(804) 675-5000
jessica.lehosit@va.gov

Principal Investigator

Jessica B Lehosit
PRINCIPAL_INVESTIGATOR
Richmond VA Medical Center, Richmond, VA

Study Locations (Sites)

Richmond VA Medical Center, Richmond, VA
Richmond, Virginia, 23249-0001
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Jessica B Lehosit, PRINCIPAL_INVESTIGATOR, Richmond VA Medical Center, Richmond, VA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-01
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-09-01
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • exoskeleton

Additional Relevant MeSH Terms

  • Parkinson's Disease