A Cross-Over Study on the Effect of Shoulder Sling Use on Balance and Functional Mobility in Patients With Hemiplegia During the Subacute Phase of Stroke Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Timed Up and Go (TUG) Test
研究概览
简要总结
This study examines whether wearing a shoulder sling can improve balance and mobility in people who are recovering from a stroke. Participants will perform simple movement and balance tests twice-once with the sling and once without. The goal is to find out if using the sling helps patients feel more stable and safe during walking and everyday activities.
详细描述
This is a cross-over study designed to evaluate the impact of shoulder sling use on balance and functional mobility in patients recovering from stroke in the subacute phase. Participants will be asked to complete three validated functional tests: the Timed Up and Go (TUG) test, the Functional Reach Test (FRT), and the Modified Four Square Step Test (mFSST). Each test will be performed twice, once with the shoulder sling and once without, in randomized order. The study aims to determine whether the sling provides measurable benefits in stability and performance during movement tasks. Data will be collected in rehabilitation centers under the supervision of clinical researchers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Clinical diagnosis of stroke in the subacute phase (up to 6 months post-onset)
- •Hemiplegia affecting one upper limb
- •Brunnstrom stage < 4 for the affected upper limb
- •Functional Ambulation Category (FAC) score > 3
- •Age between 40 and 80 years
- •Ability to follow simple instructions
- •Medically stable to participate in balance and mobility testing
- •Signed informed consent
排除标准
- •Severe cognitive impairment (e.g. MMSE < 23)
- •Visual or vestibular disorders affecting balance
- •Significant orthopedic or musculoskeletal conditions of the lower limbs
- •Uncontrolled cardiovascular or pulmonary disease
- •Use of assistive devices that prevent sling application
- •Severe aphasia interfering with understanding or communication
- •Skin lesions or injuries at the shoulder region preventing sling use
研究组 & 干预措施
Shoulder Sling
Participants perform balance and mobility tests (TUG, FRT, mFSST) while wearing a shoulder sling on the affected upper limb.
干预措施: Shoulder Sling (Device)
No Sling
The same functional tests are performed without the use of a shoulder sling.
干预措施: No Sling (Other)
结局指标
主要结局
Timed Up and Go (TUG) Test
时间窗: Within 1 day (each participant performs it twice - with and without sling)
Time required (in seconds) to stand up from a chair, walk 3 meters, turn, walk back, and sit down.
Functional Reach Test (FRT)
时间窗: Within 1 day (each participant performs it twice - with and without sling)
Distance reached (in centimeters) while standing and reaching forward without losing balance.
Modified Four Square Step Test (mFSST)
时间窗: Within 1 day (each participant performs it twice - with and without sling)
Time required to step in all four quadrants in a specified sequence.
次要结局
未报告次要终点
研究者
Arnaoutis Stylianos
Principal Investigator
University of West Attica