Parkinson Disease
Conditions
Keywords
Gait, Balance, Freezing
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.
Interventions
DEVICERobotic-assist gait training device
PD participants will walk while wearing a robotic-assist gait training device
Sponsors
Virginia Commonwealth University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 95 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of the Portable Exoskeleton | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Freezing of Gait (FOG) | 6 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). |
| Change in Balance | 6 weeks | The Berg Balance Scale (BBS) assesses balance via asking the participant to perform 14 functional activities. Each functional activity is rated on a 5 point scale from 0 (unable) to 4 (able safety or with minimal aid). The score on each functional activity is then added to get an overall score from 0 to 56. Scores range from 0 to 56 with higher scores indicating better balance. |
| Change in Walking Capacity | 6 weeks | Walking capacity will be assessed using the 6-Minute Walking Test (6MWT) that assesses distance (in feet) 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. The change in walking capacity from baseline to the week 5 treatment. |
| Change in Quality of Life (QOL) | 6 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). All items are then added to get a total score. Total scores can range from 0 to 156. The lower the total score, the better quality of life. |
| Change in Caregiver QOL | 6 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. Each item is scored from 0 to 4. Total scores are then added. Total scores range from 0 (no problem at all) to 116 (worst level of problem). |
| Change in Motor Symptoms | 6 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 (best score) to 56 (worst score) with higher scores indicating more symptoms. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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).
Robotic-assist gait training device: PD participants will walk while wearing a robotic-assist gait training device | 6 |
| Caregiver Participants 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. Each item is scored from 0 to 4. Total scores are then added. Total scores range from 0 (no problem at all) to 116 (worst level of problem). | 2 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Device broke during study | 3 | 2 |
| Overall Study | Screen failure after consent | 3 | 0 |
Baseline characteristics
| Characteristic | PD Participants | Caregiver Participants | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 2 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 2 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 2 Participants | 8 Participants |
| Region of Enrollment United States | 6 participants | 2 participants | 8 participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 5 Participants | 0 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 1 |
| other Total, other adverse events | 1 / 3 | 0 / 1 |
| serious Total, serious adverse events | 0 / 3 | 0 / 1 |
Outcome results
Primary
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.
Time frame: At the end of treatment (5 weeks)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PD Participants | Safety of the Portable Exoskeleton | 0 Number of prevented/near falls |
Secondary
Change in Balance
The Berg Balance Scale (BBS) assesses balance via asking the participant to perform 14 functional activities. Each functional activity is rated on a 5 point scale from 0 (unable) to 4 (able safety or with minimal aid). The score on each functional activity is then added to get an overall score from 0 to 56. Scores range from 0 to 56 with higher scores indicating better balance.
Time frame: 6 weeks
Population: Only 1 participant performed study activities that collected this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PD Participants | Change in Balance | Baseline | 47 score on scale |
| PD Participants | Change in Balance | 1 wk post treatment | 52 score on scale |
Secondary
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. Each item is scored from 0 to 4. Total scores are then added. Total scores range from 0 (no problem at all) to 116 (worst level of problem).
Time frame: 6 weeks
Population: Only 1 participant performed study activities that collected this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PD Participants | Change in Caregiver QOL | Prescreen visit | 18 Change in score |
| PD Participants | Change in Caregiver QOL | Post-treatment visit | 22 Change in score |
Secondary
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).
Time frame: 6 weeks
Population: Only 1 participant performed study activities that collected this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PD Participants | Change in Freezing of Gait (FOG) | Baseline | 2 Change in score |
| PD Participants | Change in Freezing of Gait (FOG) | 1 wk post treatment | 4 Change in score |
Secondary
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 (best score) to 56 (worst score) with higher scores indicating more symptoms.
Time frame: 6 weeks
Population: Only 1 participant performed study activities that collected this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PD Participants | Change in Motor Symptoms | Baseline | 55 Change in score |
| PD Participants | Change in Motor Symptoms | 1 wk post treatment | 45 Change in score |
Secondary
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). All items are then added to get a total score. Total scores can range from 0 to 156. The lower the total score, the better quality of life.
Time frame: 6 weeks
Population: Only 1 participant performed study activities that collected this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PD Participants | Change in Quality of Life (QOL) | Baseline | 53 Change in score |
| PD Participants | Change in Quality of Life (QOL) | 1 wk post treatment | 34 Change in score |
Secondary
Change in Walking Capacity
Walking capacity will be assessed using the 6-Minute Walking Test (6MWT) that assesses distance (in feet) 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. The change in walking capacity from baseline to the week 5 treatment.
Time frame: 6 weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PD Participants | Change in Walking Capacity | Baseline | 226 Total distance (feet) |
| PD Participants | Change in Walking Capacity | After 4 treatments | 182 Total distance (feet) |