Trial Outcomes & Findings for Safety and Efficacy of State-of-the-Art Exoskeleton Technology to Improve Mobility in Parkinson's Disease (NCT NCT04587193)
NCT ID: NCT04587193
Last Updated: 2024-02-28
Results Overview
Number of "prevented" or "near falls" requiring physical assistance by the investigative training team experienced by the participant during throughout the training.
TERMINATED
NA
8 participants
At the end of treatment (5 weeks)
2024-02-28
Participant Flow
Participant milestones
| Measure |
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
|
Caregiver Participants
Caregivers of persons enrolled in study (optional)
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
Reasons for withdrawal
| Measure |
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
|
Caregiver Participants
Caregivers of persons enrolled in study (optional)
|
|---|---|---|
|
Overall Study
Screen failure after consent
|
3
|
0
|
|
Overall Study
Device broke during study
|
3
|
2
|
Baseline Characteristics
Safety and Efficacy of State-of-the-Art Exoskeleton Technology to Improve Mobility in Parkinson's Disease
Baseline characteristics by cohort
| Measure |
PD Participants
n=6 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
|
Caregiver Participants
n=2 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).
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
2 participants
n=7 Participants
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
PD Participants
n=3 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
|
|---|---|
|
Safety of the Portable Exoskeleton
|
0 Number of prevented/near falls
|
SECONDARY outcome
Timeframe: 6 weeksWalking 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.
Outcome measures
| Measure |
PD Participants
n=3 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
|
|---|---|
|
Change in Walking Capacity
Baseline
|
226 Total distance (feet)
Interval 181.0 to 262.0
|
|
Change in Walking Capacity
After 4 treatments
|
182 Total distance (feet)
Interval 125.0 to 239.0
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Only 1 participant performed study activities that collected this outcome measure.
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).
Outcome measures
| Measure |
PD Participants
n=1 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
|
|---|---|
|
Change in Freezing of Gait (FOG)
Baseline
|
2 Change in score
|
|
Change in Freezing of Gait (FOG)
1 wk post treatment
|
4 Change in score
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Only 1 participant performed study activities that collected this outcome measure.
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.
Outcome measures
| Measure |
PD Participants
n=1 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
|
|---|---|
|
Change in Balance
Baseline
|
47 score on scale
|
|
Change in Balance
1 wk post treatment
|
52 score on scale
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Only 1 participant performed study activities that collected this outcome measure.
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.
Outcome measures
| Measure |
PD Participants
n=1 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
|
|---|---|
|
Change in Motor Symptoms
Baseline
|
55 Change in score
|
|
Change in Motor Symptoms
1 wk post treatment
|
45 Change in score
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Only 1 participant performed study activities that collected this outcome measure.
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.
Outcome measures
| Measure |
PD Participants
n=1 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
|
|---|---|
|
Change in Quality of Life (QOL)
Baseline
|
53 Change in score
|
|
Change in Quality of Life (QOL)
1 wk post treatment
|
34 Change in score
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Only 1 participant performed study activities that collected this outcome measure.
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).
Outcome measures
| Measure |
PD Participants
n=1 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
|
|---|---|
|
Change in Caregiver QOL
Prescreen visit
|
18 Change in score
|
|
Change in Caregiver QOL
Post-treatment visit
|
22 Change in score
|
Adverse Events
PD Participants
Caregiver Participants
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PD Participants
n=3 participants at risk
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
|
Caregiver Participants
n=1 participants at risk
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.
|
|---|---|---|
|
General disorders
Fatigue
|
33.3%
1/3 • 10 weeks
|
0.00%
0/1 • 10 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
33.3%
1/3 • 10 weeks
|
0.00%
0/1 • 10 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place