Clinical trial NCT05022355: Examination of Operative Approach in pwFSHD (Patient With Facioscapulohumeral Muscular Dystrophy)
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Facio-Scapulo-Humeral Dystrophy
Keywords: scapulotorasic arthrodesis
balance
gait
evaluation
usual care
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2021-08-26
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with FSHD and undergoing scapulothoracic arthrodesis or non-operating

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 10 meter walking test
timeFrame: once at baseline of study
measure: Gait Analyzer
timeFrame: once at baseline of study
Secondary outcomes:
measure: Berg Balance Scale
timeFrame: once at baseline of study
measure: Disabilities of the arm, shoulder and hand (DASH)
timeFrame: once at baseline of study
measure: 30 seconds sit up test
timeFrame: once at baseline of study
measure: 2-minute walk test
timeFrame: once at baseline of study
measure: Single leg stance test
timeFrame: once at baseline of study
measure: Timed up and go test
timeFrame: once at baseline of study
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpaşa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Ipek Yeldan, PhD
role: STUDY_DIRECTOR
References:
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