Safety and Efficacy of State-of-the-Art Exoskeleton Technology to Improve Mobility in Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT04587193|
Recruitment Status : Not yet recruiting
First Posted : October 14, 2020
Last Update Posted : November 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Device: Robotic-assist gait training device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Safety and Efficacy of State-of-the-Art Exoskeleton Technology to Improve Mobility in Parkinson's Disease|
|Estimated Study Start Date :||January 2021|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||May 2022|
Experimental: 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).
Device: Robotic-assist gait training device
PD participants will walk while wearing a robotic-assist gait training device
- Safety of the portable exoskeleton [ Time Frame: 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.
- Change in walking capacity [ Time Frame: Baseline, post treatment (5 weeks), 4-5 week follow up (up to 14 weeks) ]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) [ Time Frame: Baseline, post treatment (5 weeks), 4-5 week follow up (up to 14 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 [ Time Frame: Baseline, post treatment (5 weeks), 4-5 week follow up (up to 14 weeks) ]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 [ Time Frame: Baseline, post treatment (5 weeks), 4-5 week follow up (up to 14 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 to 56 with higher scores indicating more symptoms.
- Change in quality of life (QOL) [ Time Frame: Baseline, post treatment (5 weeks), 4-5 week follow up (up to 14 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) and can be summed in the PDQ39 Summary Index with lower scores indicating better QOL.
- Change in Caregiver QOL [ Time Frame: Baseline, post treatment (5 weeks), 4-5 week follow up (up to 14 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. Scores range from 0 (no problem at all) to 100 (worst level of problem).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04587193
|Contact: Gina Blackwell, MPH||804-921-9990||Gina.Blackwell@vcuhealth.org|
|Contact: Robert Hand, PT, DPT||Robert.Hand@vcuhealth.org|
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Mark Baron, MD||Virginia Commonwealth University Health System|
|Principal Investigator:||Robert Hand, PT, DPT||Virginia Commonwealth University Health System|