The Effects of Osteopathic Manual Treatment on Hemiplegic Shoulder Pain and Upper Extremity Function in Stroke Patients: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Feasibility Assessment
研究概览
简要总结
This study assesses the feasibility and safety of performing osteopathic manual treatment (OMT) for hemiplegic shoulder pain in stroke patients. This study's participants will be adults with a first-time stroke diagnosis in the past 5 years and shoulder pain on the same side affected by stroke. Eligible participants will be placed on study for approximately 6 weeks and given either OMT or a sham treatment each week.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Other members of the study team, such as those who recruit, screen, and coordinate research visits, will be masked. Additionally, the occupational therapist who performs baseline pain ratings and arm function assessments will also be masked.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be at least 18 years or older to participate in the study
- •Presence of shoulder pain on the side of the body affected by stroke
- •Patients must have a diagnosis of a first-time stroke within the past 5 years
- •Stroke type must be subcortical, brainstem, and/or right-MCA stroke. Participants with multiple stroke types within the first-time diagnosis may be included
排除标准
- •Presence of an active systemic or localized infection requiring antibiotic therapy
- •Presence of fracture in the area being treated
- •Presence of open wound in the area being treated
- •Presence of rheumatoid arthritis
- •Presence of known active malignancy
- •Presence of shoulder pain on the affected side within 3 months prior to stroke
- •Patients with left-MCA stroke diagnosis who demonstrate the presence of aphasia based on the Mississippi Aphasia Screening Test (MAST)
- •Patients who demonstrate hemispatial visual neglect based on screening motor-free visual perception test (MFVPT)
- •Patients already receiving any type of manual therapy by a certified therapist through their standard-of-care treatment
- •Patients who do not wish to participate
- •Patients who are not fit as judged by the study team
- •Patients who lack the capacity to consent for enrollment in the study based on the University of California San Diego Brief Assessment of Capacity to Consent
结局指标
主要结局
Feasibility Assessment
时间窗: From enrollment to the end of treatment at 6 weeks
The study team will assess feasibility by tracking participant recruitment, randomization, and retention. The ability to carry out the intervention protocol to completion in these participants will be assessed. Feasibility will be confirmed if 10 patients are randomized and at least 80% complete the study within the planned 1-year timeline.
次要结局
- Safety Assessment(From enrollment to the end of treatment at 6 weeks)