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

• ClinicalTrials.gov Identifier: NCT04587193
• Recruitment Status: Not yet recruiting
• First Posted: October 14, 2020
• Last Update Posted: November 9, 2020
• Sponsor: Virginia Commonwealth University
• Information provided by (Responsible Party): Virginia Commonwealth University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Parkinson Disease	Device: Robotic-assist gait training device	Not Applicable

Detailed Description:

This is a feasibility study to examine a novel application of state-of-the-art robotic-assist gait training to improve mobility in people with Parkinson's disease (PD). The study will investigate the utility of the Keeogo® exoskeleton (a robotic-assist gait training device) for people with PD. The Keeogo® offers advantages of being lightweight and portable (for eventual home use) and is relatively quick to attach and remove. The aims here are to establish the safety of the Keeogo® for gait training in persons with PD and to preliminarily assess the potential efficacy of the Keeogo® for better balance control, gait mobility and fall reduction in persons with PD.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 72 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Safety and Efficacy of State-of-the-Art Exoskeleton Technology to Improve Mobility in Parkinson's Disease
• Estimated Study Start Date: January 2021
• Estimated Primary Completion Date: March 2022
• Estimated Study Completion Date: May 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: PD participants; 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; PD participants will walk while wearing a robotic-assist gait training device

Outcome Measures

Primary Outcome Measures :

1. Safety of the portable exoskeleton [ Time Frame: At the end of treatment (5 weeks) ]
   Number of "prevented" or "near falls" requiring physical assistance by the investigative training team experienced by the participant during throughout the training.

Secondary Outcome Measures :

1. Change in walking capacity [ Time Frame: Baseline, post treatment (5 weeks), 4-5 week follow up (up to 14 weeks) ]
   Walking capacity will be assessed using the 6-Minute Walking Test (6MWT) that assesses distance walked to determine aerobic capacity and endurance. Participants will be asked to walk as far as possible in 6 minutes and the total distance will be recorded.
2. Change in freezing of gait (FOG) [ Time Frame: Baseline, post treatment (5 weeks), 4-5 week follow up (up to 14 weeks) ]
   FOG will be assessed using the 6MWT. FOG will be assess using 2 gait related questions on the Unified Parkinson's Disease Rating Scale (UPDRS). Scores are summed and range from 0 (normal) to 4 (very poor).
3. Change in balance [ Time Frame: Baseline, post treatment (5 weeks), 4-5 week follow up (up to 14 weeks) ]
   The Berg Balance Scale (BBS) assesses balance via asking the participant to perform 14 functional activities. Ability to perform the functions is rated on a 5 point scale from 0 (unable) to 4 (able safety or with minimal aid). Scores range from 0 to 56 with higher scores indicating better balance.
4. Change in motor symptoms [ Time Frame: Baseline, post treatment (5 weeks), 4-5 week follow up (up to 14 weeks) ]
   The Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part IIIMDS-UPDRS, part III will be used to assess motor symptoms and fluctuations of Parkinson Disease (PD) This outcome measure will be used to report a change in PD motor symptoms from baseline. Scores range from 0 to 56 with higher scores indicating more symptoms.
5. Change in quality of life (QOL) [ Time Frame: Baseline, post treatment (5 weeks), 4-5 week follow up (up to 14 weeks) ]
   Parkinson's Disease Questionnaire (PDQ39) is a 39 item self-report questionnaire assessing how often patients experience difficulties across the 8 quality of life dimensions of functioning and well-being. Items are scored from 0 (never) to 4 (always) and can be summed in the PDQ39 Summary Index with lower scores indicating better QOL.
6. Change in Caregiver QOL [ Time Frame: Baseline, post treatment (5 weeks), 4-5 week follow up (up to 14 weeks) ]
   Participant's caregivers QOL will be assessed using the Parkinson's Disease Carer Questionnaire (PD-Carer), a 29 item measure of health related quality of life for use with carers of people with Parkinson's disease. Scores range from 0 (no problem at all) to 100 (worst level of problem).

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 95 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

Parkinson's Participant

1. age 21 years or older,
2. PD confirmed by a movement disorder specialist using UK Brain Bank Criteria,
3. H&Y stage III, IV, or V.

Caregiver participant 1) Caregiver of PD participant and is willing to complete questionnaire

Exclusion Criteria:

Parkinson's Participant

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

Caregiver participant

1) Unwilling to complete questionnaire

Contacts and Locations

Contacts

Contact: Gina Blackwell, MPH; 804-921-9990; Gina.Blackwell@vcuhealth.org

Contact: Robert Hand, PT, DPT; Robert.Hand@vcuhealth.org

Locations

United States, Virginia

Virginia Commonwealth University

Richmond, Virginia, United States, 23298

Sponsors and Collaborators

Virginia Commonwealth University

Investigators

• Principal Investigator: Mark Baron, MD; Virginia Commonwealth University Health System
• Principal Investigator: Robert Hand, PT, DPT; Virginia Commonwealth University Health System

More Information

• Responsible Party: Virginia Commonwealth University
• ClinicalTrials.gov Identifier: NCT04587193
• Other Study ID Numbers: HM20020066
• First Posted: October 14, 2020
• Last Update Posted: November 9, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Virginia Commonwealth University:

Gait; Balance; Freezing

Additional relevant MeSH terms:

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