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?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 1 year and 10 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.