Safety and Efficacy of State-of-the-Art Exoskeleton Technology to Improve Mobility in Parkinson's Disease

NCT04587193 | Terminated Results FDA Device

• 1 other identifier: HM20020066
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the safety and efficacy of using of a portable exoskeleton for walking training in persons with Parkinson's disease that have gait mobility problems and/or postural instability.

Conditions

Parkinson Disease

Keywords

Gait; Balance; Freezing

Outcome Measures

Primary Outcomes (1)

• Safety of the Portable Exoskeleton

  Number of "prevented" or "near falls" requiring physical assistance by the investigative training team experienced by the participant during throughout the training.

  At the end of treatment (5 weeks)

Secondary Outcomes (6)

• Change in Walking Capacity

  6 weeks

• Change in Freezing of Gait (FOG)

  6 weeks

• Change in Balance

  6 weeks

• Change in Motor Symptoms

  6 weeks

• Change in Quality of Life (QOL)

  6 weeks

Study Arms (1)

PD participants

EXPERIMENTAL

Subjects will participate in a total of 10 walking sessions, twice per week for 5 weeks, while wearing a robotic-assist gait training device. There will also be 3 additional visits for assessments at: baseline (up to 1 prior to treatment), post (1 week after last treatment), and final (4-6 weeks after last treatment).

Device: Robotic-assist gait training device

Interventions

Robotic-assist gait training device DEVICE

PD participants will walk while wearing a robotic-assist gait training device

PD participants

Eligibility Criteria

• Age: 21 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parkinson's Participant
• age 21 years or older,
• PD confirmed by a movement disorder specialist using UK Brain Bank Criteria,
• H\&Y stage II, III, IV, or V.
• Caregiver participant
• Caregiver of PD participant and is willing to complete questionnaire
• moderate to severe cognitive impairment / dementia (Montreal Cognitive Assessment \< 17/30) except in cases where the clinician and the participants Legally Authorized Representative both determine the participant can safely complete the study

You may not qualify if:

• Parkinson's Participant
• neurological, musculoskeletal, or other disorders unrelated to PD contributing to impairment of gait, stance, balance or coordination,
• history of implantable cardiac device or ablative surgery,
• moderate to severe cognitive impairment / dementia (Montreal Cognitive Assessment \< 17/30),
• uncontrolled orthostatic hypotension,
• feeding tube or associated port placement (PEG/J-PEG),
• body height less than 5'1" or greater than 6'3" and
• body weight greater than 250 pounds.
• Caregiver participant
• \) Unwilling to complete questionnaire

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Brian Berman
• Organization: Virginia Commonwealth University

brian.berman@vcuhealth.org

800-762-6161

Study Officials

• Mark Baron, MD

  Virginia Commonwealth University Health System

  PRINCIPAL INVESTIGATOR

• Robert Hand, PT, DPT

  Virginia Commonwealth University Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: October 14, 2020
• Study Start: January 15, 2020
• Primary Completion: December 22, 2022
• Study Completion: January 2, 2023
• Last Updated: February 28, 2024
• Results First Posted: February 28, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)