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临床试验/NCT05884944
NCT05884944招募中不适用

Effects Of Osteopathic Manipulative Medicine(OMM) On Lower Extremity Muscle Characteristics In Parkinson's Disease(PD) Patients

New York Institute of Technology2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年7月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
2
主要终点
Mechanical stress via the MyotonPro

研究概览

简要总结

The purpose of the study is to investigate the effects that Osteopathic Manipulative Medicine has on lower extremity muscle characteristics in PD. Muscle stiffness, range of motion, and gait will be measured.

Participants will be asked to attend one in person session at the NYIT Academic Health Care Center. Participants will be randomly assigned to a control or experimental group. After a visit with the treating physician, both groups will have muscle stiffness tested using a myotonometry meter via a MyotonPRO device, gait measured while walking on a treadmill for 2 minutes before and after treatment, and range of motion tested using a goniometer. One week after the visit, participants will be asked to complete a brief survey over the phone with one of the study investigators.

详细描述

Parkinsonism, most commonly caused by Parkinson's disease (PD), is a syndrome characterized by rest tremor, rigidity, bradykinesia, and postural instability. Gait speed and endurance directly inhibit the independence and community engagement for those with Parkinson's disease (PD). Pain was ranked as one of the most troublesome nonmotor symptoms associated with PD. Rigidity is commonly associated with pain in patients with PD. Osteopathic medicine treats somatic dysfunction which is the impaired function of body components including the somatic, skeletal, myofascial, vascular, lymphatic, and neural systems. Osteopathic manipulative treatment (OMT) will be applied to the lower extremity (LE), specifically muscle energy technique (MET) to the hip, knee, and ankle bilaterally. A sham control group will receive passive range of motion (PROM) joint movement of the hip, knee, and ankles bilaterally without reaching joint physiologic barrier. Muscle and gait parameters, ROM, Timed Up & Go (TUG) and LE functionality will be assessed and juxtaposed. Based on preliminary results of muscle measurements, stiffness and relaxation improved in a patient with PD before and after LE OMT and demonstrated to be feasible. Investigators intend for the patients who receive OMT to improve LE muscle quality, gait, ROM, TUG, and daily functionality. Through this research Investigators hope to demonstrate that OMM as a supplemental treatment regimen can improve quality of life in those living with PD.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of Parkinson's disease as per a neurologist, a severity of 2-4 on the Hoehn and Yahr (H-Y) Scale
  • Able to receive OMM
  • Able to be in a supine and prone position for MyotonPRO measurements
  • Able to ambulate for gait measurements
  • Have musculoskeletal complaints of leg pain/cramping or gait abnormalities due to their PD

排除标准

  • Presence of severe fasciculations based on clinical judgment due to interference with measurements
  • Gait disorders not attributed to PD
  • Presence of other medical neurologic diagnoses that can affect outcome measures such as muscle tone/stiffness and ambulation (ie stroke, multiple sclerosis)

结局指标

主要结局

Mechanical stress via the MyotonPro

时间窗: Pre and Post intervention(1 hour)- change is being assessed

Mechanical Stress Relaxation Time \[ms\]

Step Cycle time via the Biodex Gait Trainer 3

时间窗: Pre and Post intervention(1 hour)- change is being assessed

Gait will be investigated utilizing the Biodex Gait Trainer 3. Measurements will be taken during a two minute walk before and after treatment or sham protocol at the visit. Step cycle time- Cycles/ second

Average step length via the Biodex Gait Trainer 3

时间窗: Pre and Post intervention(1 hour)- change is being assessed

Gait will be investigated utilizing the Biodex Gait Trainer 3. Measurements will be taken during a two minute walk before and after treatment or sham protocol at the visit. Average Step length in Cm

Step Symmetry- time on each foot via the Biodex Gait Trainer 3

时间窗: Pre and Post intervention(1 hour)- change is being assessed

Gait will be investigated utilizing the Biodex Gait Trainer 3. Measurements will be taken during a two minute walk before and after treatment or sham protocol at the visit. Measurements include step symmetry via the time on each foot in percentage(%)

Goniometer- Knee ROM - Extension

时间窗: Pre and Post intervention(1 hour)- change is being assessed

A goniometer will be used to assess range of motion of the knee in degrees

Dynamic Stiffness via the MyotonPro

时间窗: Pre and Post intervention(1 hour)- change is being assessed

Dynamic Stiffness \[N/m\]

Goniometer- Hip ROM Flexion

时间窗: Pre and Post intervention(1 hour)- change is being assessed

A goniometer will be used to assess range of motion of the hip in degrees

Goniometer- Hip ROM Extension

时间窗: Pre and Post intervention(1 hour)- change is being assessed

A goniometer will be used to assess range of motion of the hip in degrees

Goniometer- Hip ROM (Flexion and Extension)

时间窗: Pre and Post intervention(1 hour)- change is being assessed

A goniometer will be used to assess range of motion of the hip in degrees

The Timed Up & Go- 3 Meter walk

时间窗: Pre and Post intervention(1 hour)- change is being assessed

The Timed Up \& Go (TUG) test measures one's ability to rise up from a seated chair position, walk 3 meters, turn, walk back, and sit down in the chair- measure in seconds

Goniometer- Knee ROM - Flexion

时间窗: Pre and Post intervention(1 hour)- change is being assessed

A goniometer will be used to assess range of motion of the Knee in degrees

Goniometer- Ankle ROM- Dorsiflexion

时间窗: Pre and Post intervention(1 hour)- change is being assessed

A goniometer will be used to assess range of motion of the ankle in degrees

Goniometer- Ankle ROM- Plantarflexion

时间窗: Pre and Post intervention(1 hour)- change is being assessed

A goniometer will be used to assess range of motion of the ankle in degrees

次要结局

  • Lower Extremity Functional Scale (LEFS)(Pre intervention and 1 week Post intervention - change is being assessed)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sheldon Yao

Chair, Professor OMM Department

New York Institute of Technology

研究点 (2)

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