Clinical trial NCT04587193: 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
Overall status: TERMINATED
Phase: NA
Conditions: Parkinson Disease
Keywords: Gait
Balance
Freezing
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 8
Sex: ALL
Minimum age (years): 21
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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 II, III, IV, or V.

Caregiver participant

1. Caregiver of PD participant and is willing to complete questionnaire
2. 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

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

Primary outcomes:
measure: Safety of the Portable Exoskeleton
timeFrame: At the end of treatment (5 weeks)
Secondary outcomes:
measure: Change in Walking Capacity
timeFrame: 6 weeks
measure: Change in Freezing of Gait (FOG)
timeFrame: 6 weeks
measure: Change in Balance
timeFrame: 6 weeks
measure: Change in Motor Symptoms
timeFrame: 6 weeks
measure: Change in Quality of Life (QOL)
timeFrame: 6 weeks
measure: Change in Caregiver QOL
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University Health System
name: Mark Baron, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Commonwealth University Health System
name: Robert Hand, PT, DPT
role: PRINCIPAL_INVESTIGATOR
References: