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COVID-19 prevented the study from being able to be completed
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic-assist gait training device | Device | PD participants will walk while wearing a robotic-assist gait training device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks |
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Inclusion Criteria:
Parkinson's Participant
Caregiver participant
Exclusion Criteria:
Parkinson's Participant
Caregiver participant
1) Unwilling to complete questionnaire
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| Name | Affiliation | Role |
|---|---|---|
| Mark Baron, MD | Virginia Commonwealth University Health System | Principal Investigator |
| Robert Hand, PT, DPT | Virginia Commonwealth University Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Caregiver Participants | Caregivers of persons enrolled in study (optional) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | Number of prevented/near falls | At the end of treatment (5 weeks) |
|
10 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Berman | Virginia Commonwealth University | 800-762-6161 | brian.berman@vcuhealth.org |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 1, 2022 | Jan 31, 2024 | Prot_002.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 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). | 6 weeks |
| 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. | 6 weeks |
| 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. | 6 weeks |
| 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. | 6 weeks |
| 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). | 6 weeks |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 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. | Posted | Mean | Full Range | Total distance (feet) | 6 weeks |
|
|
|
| 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). | Only 1 participant performed study activities that collected this outcome measure. | Posted | Number | Change in score | 6 weeks |
|
|
|
| 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. | Only 1 participant performed study activities that collected this outcome measure. | Posted | Number | score on scale | 6 weeks |
|
|
|
| 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. | Only 1 participant performed study activities that collected this outcome measure. | Posted | Number | Change in score | 6 weeks |
|
|
|
| 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. | Only 1 participant performed study activities that collected this outcome measure. | Posted | Number | Change in score | 6 weeks |
|
|
|
| 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). | Only 1 participant performed study activities that collected this outcome measure. | Posted | Number | Change in score | 6 weeks |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 1 |
| 3 |
| EG001 | Caregiver Participants | Subjects will be asked to complete the Parkinson's Disease Carer Questionnaire 3 times; once at the PD patient's screening visit, once at the PD patient's post-treatment visit and lastly are the PD patient's durability visit. | 0 | 1 | 0 | 1 | 0 | 1 |
| Muscle weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |