None listed
Conditions
Brief summary
The Bionics Institute Rigidity Device (BiRD) is a palm-worn device intended to be used to measure the severity of movement problems seen in people with Parkinson's disease, including uncontrollable shaking (tremor), slowness of movement (bradykinesia) and joint stiffness (rigidity). The aim of the study is to evaluate its performance through a clinical feasibility study. This will involve 20 healthy adults and 60 people with Parkinson's disease, where half the participants with Parkinson's disease are treated with medication and the other half are primarily treated with deep brain stimulation (DBS). Participants will be asked to make a series of postures and movements as guided by standard clinical tests while wearing the device. Testing will occur under different treatment scenarios to ensure it works in each situation. Some tests will last about half an hour, whereas other tests will take approximately three hours. The data from the device will be compared to regular clinical assessments completed by a health professional to ensure they tell us similar information about the movement problems. A previous pilot study has suggested that information extracted from the device will relate to clinical assessments and is safe to use.
Interventions
The Bionics Institute Rigidity Device (BiRD) is an instrumented device worn on the palm of the hand. A miniature motor flexes and extends the third digit while a force sensor measures the force required to achieve range of movement. An onboard inertial measurement unit tracks movement of the hand.
Two cohorts of participants with Parkinson's disease will be recruited into the study:
1. Participants with Parkinson's disease predominantly treated with medication, who are undergoing an anti-Parki
The Bionics Institute Rigidity Device (BiRD) is an instrumented device worn on the palm of the hand. A miniature motor flexes and extends the third digit while a force sensor measures the force required to achieve range of movement. An onboard inertial measurement unit tracks movement of the hand. Two cohorts of participants with Parkinson's disease will be recruited into the study: 1. Participants with Parkinson's disease predominantly treated with medication, who are undergoing an anti-Parkinsonian medication withdrawal challenge as part of their standard clinical care. 2. Participants with Parkinson's disease predominantly treated with bilateral deep brain stimulation (DBS) located in the subthalamic nucleus region. Each participant will attend a single study visit, no follow-up visits are required. Research team members trained to operate the BiRD will provide instructions and assist participants through all assessments. During each assessment, participants will be asked to make a series of postures and movements as guided by standard clinical tests while wearing the device. Depending on the participant cohort, participants with Parkinson's disease will be assessed using the BiRD under the following conditions: 1. Participants with Parkinson's disease predominantly treated with medication will be assessed following an overnight withdrawal of medication. This session should last no longer than 1.5 hours and may be conducted in the clinic as an adjunct to their outpatient appointment. 2. Participants with Parkinson's disease predominantly treated with DBS will be assessed under multiple conditions: without DBS therapy, with their standard DBS therapy, and at pre-defined DBS stimulation amplitudes. A maximum of 12 DBS stimulation amplitudes will be investigated, with each stimulation intensity incremented after a nominated time interval (no longer than 10 minutes). Each stimulation increment will include a short wash-in period and a BiRD assessment. Participants may rest during any additional time prior to the scheduled stimulation increment. This session should last no longer than 3.5 hours and will be conducted at a research institution.
Sponsors
Bionics Institute
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
All participants with Parkinson's disease: * Have a diagnosis of Parkinson's disease by a neurologists as per the UK Parkinson's Disease Brain Bank Diagnostic Criteria * Are capable of providing informed consent * Are capable of attending the research site for data collection. Participants with Parkinson's disease who are primarily treated with deep brain stimulation: * Have deep brain stimulation electrodes implanted bilaterally into the subthalamic nucleus region * Experience stable management, defined as no changes to medication or DBS program for a period of two months prior to data collection. Healthy volunteers: * Are in good general health * Are capable of providing informed consent * Are capable of attending the research site.
Exclusion criteria
All participants with Parkinson's disease: * Have a significantly limited range of movement at the metacarpal joints * Have a known or suspected diagnosis of bone disease that affects the upper limb * Have a known or suspected diagnosis of joint disorder that affects the upper limb * Have a disease or disorder affecting the neuromuscular system * Previous surgical intervention to hand or finger, including amputation * Previous history of brain surgery other than DBS implantation * Comorbidities affecting rigidity, tremor, bradykinesia. Participants with Parkinson's disease predominantly treated with DBS: * Implanted with DBS less than three months prior to data collection. Healthy volunteers: * Have a limited range of movement at the metacarpal joints * Have a known or suspected diagnosis of bone disease that affects the upper limb * Have a known or suspected diagnosis of joint disorder that affects the upper limb * Have a disease or disorder affecting the neuromuscular system * Previous surgical intervention to hand or finger, including amputation * Previous history of brain surgery * Current prescription of medication known to cause changes in muscle tone, tremor, balance or other movement problems.
Outcome results
None listed