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

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Primary Purpose

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Robotic-assist gait training device

About this trial

This is an interventional supportive care trial for Parkinson Disease focused on measuring Gait, Balance, Freezing

Eligibility Criteria

21 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

1) Unwilling to complete questionnaire

Sites / Locations

Virginia Commonwealth University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PD participants

Arm Description

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in walking capacity

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.

Change in freezing of gait (FOG)

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).

Change in balance

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.

Change in motor symptoms

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.

Change in quality of life (QOL)

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.

Change in Caregiver QOL

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).

Full Information

NCT ID

NCT04587193

First Posted

October 8, 2020

Last Updated

February 22, 2023

Sponsor

Virginia Commonwealth University

1. Study Identification

Unique Protocol Identification Number

NCT04587193

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Terminated

Why Stopped

COVID-19 prevented the study from being able to be completed

Study Start Date

January 15, 2020 (Actual)

Primary Completion Date

December 22, 2022 (Actual)

Study Completion Date

January 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Virginia Commonwealth University

4. Oversight

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

Data Monitoring Committee

No

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease

Keywords

Gait, Balance, Freezing

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PD participants

Arm Type

Experimental

Arm Description

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).

Intervention Type

Device

Intervention Name(s)

Robotic-assist gait training device

Intervention Description

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

Primary Outcome Measure Information:

Title

Safety of the portable exoskeleton

Description

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

Time Frame

At the end of treatment (5 weeks)

Secondary Outcome Measure Information:

Title

Change in walking capacity

Description

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.

Time Frame