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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
Sponsor study identifier
observational
24
1 country
1
Study Start
November 27, 2021
Actual (reported)Primary Completion
February 23, 2022
Actual (reported)Study Completion
August 16, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 16, 2022
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 21, 2021
Actual (reported)August 26, 2021
Actual (reported)November 27, 2021
Actual (reported)February 23, 2022
Actual (reported)August 16, 2022
Actual (reported)10 meter walking test
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.
once at baseline of study
Gait Analyzer
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.
once at baseline of study
Berg Balance Scale
once at baseline of study
Disabilities of the arm, shoulder and hand (DASH)
once at baseline of study
30 seconds sit up test
once at baseline of study
2-minute walk test
once at baseline of study
Single leg stance test
once at baseline of study
Individuals diagnosed with FSHD who have undergone unilateral or bilateral surgery who meet the inclusion criteria. application of determined outcome scales on patients
Participants diagnosed with FSHD who have not undergone any surgery, who meet the inclusion criteria. application of determined outcome scales on patients
Patients diagnosed with FSHD and undergoing scapulothoracic arthrodesis or non-operating
Istanbul University-Cerrahpaşa
Istanbul, 34500, Turkey (Türkiye)
Fecek C, Emmady PD. Facioscapulohumeral Muscular Dystrophy. 2023 Jun 26. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK559028/
Rijken NH, van Engelen BG, Weerdesteyn V, Geurts AC. Clinical Functional Capacity Testing in Patients With Facioscapulohumeral Muscular Dystrophy: Construct Validity and Interrater Reliability of Antigravity Tests. Arch Phys Med Rehabil. 2015 Dec;96(12):2201-6. doi: 10.1016/j.apmr.2015.08.429. Epub 2015 Sep 9.
Ipek Yeldan, PhD
Istanbul University - Cerrahpasa
24 participants (actual enrollment reported by the registry).
First Submitted
August 21, 2021
First Posted
August 26, 2021
Study Start
November 27, 2021
Actual (reported)Contact the study team to confirm eligibility.
Tawil R, Van Der Maarel SM. Facioscapulohumeral muscular dystrophy. Muscle Nerve. 2006 Jul;34(1):1-15. doi: 10.1002/mus.20522.
Bayram S, Kendirci AS, Karalar S, Durmus Tekce H, Parman FY, Akgul T, Durmaz H. Correlations between radiographic spinopelvic parameters and health-related quality of life: A prospective evaluation of 37 patients with facioscapulohumeral muscular dystrophy. Clin Neurol Neurosurg. 2020 Nov;198:106137. doi: 10.1016/j.clineuro.2020.106137. Epub 2020 Aug 5.
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Statland JM, Tawil R. Risk of functional impairment in Facioscapulohumeral muscular dystrophy. Muscle Nerve. 2014 Apr;49(4):520-7. doi: 10.1002/mus.23949. Epub 2014 Feb 10.
Iosa M, Mazza C, Pecoraro F, Aprile I, Ricci E, Cappozzo A. Control of the upper body movements during level walking in patients with facioscapulohumeral dystrophy. Gait Posture. 2010 Jan;31(1):68-72. doi: 10.1016/j.gaitpost.2009.08.247. Epub 2009 Sep 25.
Rijken NH, van der Kooi EL, Hendriks JC, van Asseldonk RJ, Padberg GW, Geurts AC, van Engelen BG. Skeletal muscle imaging in facioscapulohumeral muscular dystrophy, pattern and asymmetry of individual muscle involvement. Neuromuscul Disord. 2014 Dec;24(12):1087-96. doi: 10.1016/j.nmd.2014.05.012. Epub 2014 Jun 26.
Aprile I, Padua L, Iosa M, Gilardi A, Bordieri C, Frusciante R, Russo G, Erra C, De Santis F, Ricci E. Balance and walking in facioscapulohumeral muscular dystrophy: multiperspective assessment. Eur J Phys Rehabil Med. 2012 Sep;48(3):393-402. Epub 2012 Jun 20.
Rijken NH, van Engelen BG, de Rooy JW, Weerdesteyn V, Geurts AC. Gait propulsion in patients with facioscapulohumeral muscular dystrophy and ankle plantarflexor weakness. Gait Posture. 2015 Feb;41(2):476-81. doi: 10.1016/j.gaitpost.2014.11.013. Epub 2014 Dec 2.
Primary Completion
February 23, 2022
Actual (reported)Study Completion
August 16, 2022
Actual (reported)Last Updated
November 8, 2022
Record last verified: 2022-11
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