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Manual Therapy
OMM for Parkinson's Disease
N/A
Recruiting
Research Sponsored by New York Institute of Technology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre and post intervention(1 hour)- change is being assessed
Awards & highlights
Study Summary
This trial will assess how Osteopathic Manipulative Medicine affects lower limb muscles in people with Parkinson's Disease. Participants will have their muscle stiffness, range of motion, and gait tested during an in-person visit and a follow-up phone survey.
Who is the study for?
This trial is for Parkinson's disease patients who can walk and have leg pain or gait issues because of their condition. They should be at a moderate stage (2-4 on the H-Y Scale) and able to lie down for tests. People with severe muscle twitching, non-PD related walking problems, or other neurological conditions like stroke or MS cannot join.Check my eligibility
What is being tested?
The study compares Osteopathic Manipulative Medicine (OMM), which involves hands-on techniques to improve muscle function, against a sham treatment that mimics OMM without active intervention. Muscle stiffness, walking ability, and joint movement are measured before and after sessions.See study design
What are the potential side effects?
Since this trial involves non-invasive treatments like light touch or manual therapy rather than drugs, side effects may include temporary discomfort or soreness in treated areas but are generally minimal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre and post intervention(1 hour)- change is being assessed
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre and post intervention(1 hour)- change is being assessed
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Average step length via the Biodex Gait Trainer 3
Dynamic Stiffness via the MyotonPro
Goniometer- Ankle ROM- Dorsiflexion
+10 moreSecondary outcome measures
Lower Extremity Functional Scale (LEFS)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Interventional Group- OMM- Muscle energyExperimental Treatment1 Intervention
For the OMM treatment group, an osteopathic manipulative treatment protocol will be applied to the lower extremities, specifically muscle energy technique (MET) to the hip, knee, and ankle bilaterally based on the protocol from Atlas of Osteopathic Techniques. The adductor, extensor, and flexor muscles of the hip joint will be treated, the extensors and flexors of the knee joint will be treated, and the plantar and dorsiflexion muscles of the ankle will be treated
Group II: Control Group- Sham- Light touch, not reaching restrictive barrierPlacebo Group1 Intervention
Joint articulation without engaging joint barriers The sham group will serve as the control group and will receive a sham-control procedure as outlined in the paper by Wells, et al in which they will undergo voluntary ROM and then passive movement with the same joint movements without reaching their barrier and no isometric contraction (Wells et al. 1999) The proposed sham procedure will occupy the same amount of time as MET treatment.
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Who is running the clinical trial?
New York Institute of TechnologyLead Sponsor
51 Previous Clinical Trials
2,051 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My walking difficulties are not caused by Parkinson's disease.I have severe muscle twitches that affect tests.I do not have neurological conditions like stroke or multiple sclerosis.I can receive oral medication.I can lie on my back and stomach comfortably.I can walk on my own for tests.I have Parkinson's disease with a moderate severity level.I experience leg pain, cramping, or walking difficulties due to Parkinson's disease.
Research Study Groups:
This trial has the following groups:- Group 1: Control Group- Sham- Light touch, not reaching restrictive barrier
- Group 2: Interventional Group- OMM- Muscle energy
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the recruitment phase of this trial still ongoing?
"Affirmative. Per the information available on clinicaltrials.gov, this experiment is presently enrolling participants and was posted initially on June 1st 2023 with a most recent update logged in May 23rd 2023. In total, they are looking for twenty patients from one center to complete their research."
Answered by AI
To what extent is this experiment involving individuals?
"Absolutely. According to clinicaltrials.gov, this research is still recruiting members since it was posted on June 1st 2023 and its most recent update occurred on May 23rd 2023. This investigation requires a total of 20 patients who will be monitored from one medical centre."
Answered by AI
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