Continuous passive motion device (… for Parkinson's (NCT06596187)
Distinguish reflexive tightness from stiffness
- Trial ID
- NCT06596187
- Official Title
- Differential Assessment of Hypertonia Related to CNS Impairment
- Goal
- Distinguish reflexive tightness from stiffness
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Chang Gung University
- Study Type
- INTERVENTIONAL
- Enrollment
- 45 participants
- Conditions
- SCI - Spinal Cord Injury, PD - Parkinson's Disease
- Interventions
- Continuous passive motion device (CPM) of ankle - fast, Continuous passive motion device (CPM) of ankle - slow
Summary For Families
The goal is to tell apart different kinds of increased muscle tone from central nervous system problems, comparing people with chronic spinal cord injury to those with Parkinson's disease so clinicians can better recognize reflexive spasticity versus Parkinsonian stiffness. The approach uses a continuous passive motion device to move the ankle at slow and fast speeds, watching how muscles and reflexes respond to passive stretch, so faster stretches will highlight velocity-dependent reflex spasticity while slower movement reveals more constant rigidity; this is a device-based assessment rather than a drug treatment. Adults 20 and older with a clinical diagnosis of Parkinson's disease or with chronic spinal cord injury longer than one year can join, but people with leg musculoskeletal injuries or osteoporosis are excluded, and the SCI group also excludes pacemakers, current antispastic or antidepressant use, venous thromboembolism, or impaired soleus H-reflex function.
Locations
- Chang Gung University, Taoyuan, Taiwan
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Continuous passive motion device (CPM) of ankle - fast. The goal is to tell apart different kinds of increased muscle tone from central nervous system problems, comparing people with chronic spinal cord injury to those with Parkinson's disease so clinicians can better recognize reflexive spasticity versus Parkinsonian stiffness. The approach uses a continuous passive motion device to move the ankle at slow and fast speeds, watching how muscles and reflexes respond to passive stretch, so faster stretches will highlight velocity-dependent reflex spasticity while slower movement reveals more constant rigidity; this is a device-based assessment rather than a drug treatment. Adults 20 and older with a clinical diagnosis of Parkinson's disease or with chronic spinal cord injury longer than one year can join, but people with leg musculoskeletal injuries or osteoporosis are excluded, and the SCI group also excludes pacemakers, current antispastic or antidepressant use, venous thromboembolism, or impaired soleus H-reflex function.
- Who can participate?
- Participants must be at least 20 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 1 year and 10 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another.