Robotic Apparel to Prevent Freezing of Gait in Parkinson Disease
ConditionParkinson Disease (PD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorHarvard Medical School (HMS and HSDM)
About this trial
Freezing-of-gait (FoG) in Parkinson Disease (PD) is one of the most vivid and disturbing gait phenomena in neurology. Often described by patients as a feeling of "feet getting glued to the floor," FoG is formally defined as a "brief, episodic absence or marked reduction of forward progression of the feet despite the intention to walk." This debilitating gait phenomena is very common in PD, occurring in up to 80% of individuals with severe PD. When FoG arrests walking, serious consequences can occur such as loss of balance, falls, injurious events, consequent fear of falling, and increased hospitalization. Wearable robots are capable of augmenting spatiotemporal gait mechanics and are emerging as viable solutions for locomotor assistance in various neurological populations. For the proposed study, our goal is to understand how low force mechanical assistance from soft robotic apparel can best mitigate gait decline preceding a freezing episode and subsequent onset of FoG by improving spatial (e.g. stride length) and temporal features (e.g. stride time variability) of walking. We hypothesize that the ongoing gait-preserving effects can essentially minimize the accumulation of motor errors that lead to FoG. Importantly, the autonomous assistance provided by the wearable robot circumvents the need for cognitive or attentional resources, thereby minimizing risks for overloading the cognitive systems -- a known trigger for FoG, thus enhancing the repeatability and robustness of FoG-preventing effects.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18-90 years old
Self-reported Freezing of Gait due to PD
Score of 21 or higher on the cognitive screening test (Montreal Cognitive Assessment Score (MoCA))
Independent ambulation (with or without an assistive device, no physical assistance) for at least 20 meters
Disqualifiers
More than 2 falls in the previous month, as a result of gait impairment (may enroll under clinician discretion)
Major surgery in the last 6 months that interferes with walking (may enroll under clinician discretion)
Gait deficits due to missing limbs
Experience chronic pain that interferes with walking ability (may enroll under clinician discretion)
Trial design
Design model
Single group
Treatments tested in this trial
Robotic Apparel
DeviceA robotic apparel system is a portable, lightweight textile-based wearable robot that is worn around the waist and thighs. The apparel provides assistive flexion moment about the hip joint during the swing phase of gait by spooling in a cable that connects the thigh wraps to the front of the waist belt. Inertial measurement units embedded in the thigh wraps are used to control the timing of the robotic apparel assistance. Robotic apparel assistance magnitude is delivered as a small percentage of the bodyweight of the wearer.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Multi-visit ambulatory activities with soft robotic apparelExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in percent time spent freezing
Percent time spent freezing refers to cumulative duration spent freezing divided by the total duration of the task, expressed as percentage. Change in this outcome measure refers to the difference in percent time spent freezing during activities with and without assistance of robotic apparel.
Time frame
Visit 4 (within 6 months after enrollment)2
Change in percent time spent freezing
Percent time spent freezing refers to cumulative duration spent freezing divided by the total duration of the task, expressed as percentage. Change in this outcome measure refers to the difference in percent time spent freezing during activities with and without assistance of robotic apparel.
Time frame
Visit 5 (within 6 months after enrollment)3
Change in percent time spent freezing
Percent time spent freezing refers to cumulative duration spent freezing divided by the total duration of the task, expressed as percentage. Change in this outcome measure refers to the difference in percent time spent freezing during activities with and without assistance of robotic apparel.
Time frame
Visit 6 (within 6 months after enrollment)4
Change in percent time spent freezing
Percent time spent freezing refers to cumulative duration spent freezing divided by the total duration of the task, expressed as percentage. Change in this outcome measure refers to the difference in percent time spent freezing during activities with and without assistance of robotic apparel.
Time frame
Visit 7 (within 6 months after enrollment)Secondary outcomes
1
Change in freezing-of-gait ratio
Freezing-of-gait ratio refers to the ratio between total power in the 3-8Hz band and the total power in the 0.5-3Hz band in the shank inertial measurement units. Change in this outcome measure refers to difference in freezing-of-gait ratio during activities with and without assistance of robotic apparel.
Time frame
Visit 4 (within 6 months after enrollment)2
Change in freezing-of-gait ratio
Freezing-of-gait ratio refers to the ratio between total power in the 3-8Hz band and the total power in the 0.5-3Hz band in the shank inertial measurement units. Change in this outcome measure refers to difference in freezing-of-gait ratio during activities with and without assistance of robotic apparel.
Time frame
Visit 5 (within 6 months after enrollment)3
Change in freezing-of-gait ratio
Freezing-of-gait ratio refers to the ratio between total power in the 3-8Hz band and the total power in the 0.5-3Hz band in the shank inertial measurement units. Change in this outcome measure refers to difference in freezing-of-gait ratio during activities with and without assistance of robotic apparel.
Time frame
Visit 6 (within 6 months after enrollment)4
Change in freezing-of-gait ratio
Freezing-of-gait ratio refers to the ratio between total power in the 3-8Hz band and the total power in the 0.5-3Hz band in the shank inertial measurement units. Change in this outcome measure refers to difference in freezing-of-gait ratio during activities with and without assistance of robotic apparel.
Time frame
Visit 7 (within 6 months after enrollment)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Harvard Medical School (HMS and HSDM)
Lead sponsor
Michael J. Fox Foundation for Parkinson's Research
Collaborator
Boston University
Collaborator
Source ClinicalTrials.gov