The Comparison of the Effects of Scapulothoracic Arthrodesis Surgery Versus Usual Care on Balance and Gait Parameters in Patients With Fascioscapulohumeral Dystrophy: One-Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Gait Analyzer
研究概览
简要总结
Facioscapulohumeral Muscular Dystrophy (FSHD) is one of the most common forms of muscular dystrophy, characterized by pronounced skeletal novelistic weakness and with a broad spectrum of diseases. It is a hereditary disease seen in 3-5/100,000 of society, usually starting with weakness in the facial and shoulder muscles and progressing to the trunk, pelvis and leg muscles, giving symptoms in the twenties. In FSHD, which shows slow progression and can lead to loss of ambulation ability in about 20% of patients, patients may have difficulty performing activities above shoulder level with the influence of the periscapular area.
Skeletal muscle weakness leads to posture and balance disorders, and postural instability is a common problem in patients with FSHD. Weakness of the trunk and lower limb muscles found in more than half of patients causes problems with postural balance and walking. The calf, iliopsoas, and gluteus maximus muscles together form the main determinants of walking speed in healthy people, where kalf muscles are known to contribute the most. Individuals with FSHD have been reported to have decreased speed, step length, and step frequency compared to healthy controls. Impaired upper body control can compromise the maintenance of dynamic stability. In patient with FSHD the effects of muscle tone, motor coordination, loss of joint range of motion and muscle weakness on posture, balance control and gait are observed more clearly.
The aim of the study was to compare the effects of scapular management treatments on balance and gait in FSHD patients.
H0: There is no difference in balance and walking parameters of patients with FSHD who have had scapulothoracic arthrodesis surgery and have not undergone surgery.
H1: There is a difference in balance and walking parameters of patients with FSHD who have had scapulothoracic arthrodesis surgery and have not undergone surgery.
详细描述
Voluntary patients who have been diagnosed with FSHD will be included in the study. Signed voluntary consent will be obtained from participants. Participants will be divided into two groups. One group will include patients who have undergone scapulothoracic arthrodesis surgery, while the other group will include patients who have not undergone surgery. Both groups will undergo some outcome measures to assess their balance and walking.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years
- •Score between 0,5 and 3,5 according to CSS (clinical severity rating)
- •Score between 3 and 5 according to FAS (functional ambulation scale)
- •Being included in the surgical group the patient has undergone unilateral or bilateral scapulothoracic arthrodesis surgery
排除标准
- •Presence of lower extremity orthopedic problems/problems that can cause balance and walking problems
- •Presence of any other upper limb orthopedic problems/problems and surgery
- •Having undergone Spinal fusion surgery
- •Presence of additional neurological problems/problems
- •Having a level of visual and auditory problems that will prevent communication
结局指标
主要结局
Gait Analyzer
时间窗: once at baseline of study
It is a smartphone-based application for analyzing walking parameters in real time. It can measure walking speed, step time, step length, cadence and symmetry.
10 meter walking test
时间窗: once at baseline of study
during the test, the patient is asked to walk at a normal walking speed at a distance of 10 meters determined before the test. The time it has traveled the specified distance is recorded. It is a long-term performance test used for dynamic balance assessment.
次要结局
- 30 seconds sit up test(once at baseline of study)
- 2-minute walk test(once at baseline of study)
- Timed up and go test(once at baseline of study)
- Disabilities of the arm, shoulder and hand (DASH)(once at baseline of study)
- Single leg stance test(once at baseline of study)
- Berg Balance Scale(once at baseline of study)
研究者
Aysenur Erekdag
BSc
Istanbul University - Cerrahpasa (IUC)