Facioscapulohumeral Muscular Dystrophy Clinical Trial
Official title:
Does the Upper Extremity Rehabilitation Program Implemented on Individuals With Facioscapulohumeral Dystrophy, Followed by Various Interventions, Have an Impact on Function, Balance, and Gait?
Verified date | October 2023 |
Source | Istanbul University - Cerrahpasa (IUC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Facioscapulohumeral Muscular Dystrophy (FSHD) is one of the most common forms of muscular dystrophy, characterized by pronounced skeletal 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. The goal of FSHD treatment is to improve muscle strength and/or function. Treatments include medical, conservative and surgical methods. The aim of surgical methods is to improve shoulder function and prevent pain caused by the movements of the scapula. The publications on physiotherapy interventions and aerobic exercise are available as conservative treatment. In patients diagnosed with FSHD, conservative treatment is frequently used to improve muscle strength, regulate function and improve the quality of life of patients. Patients with FSHD use their affected upper extremities asymmetrically, which leads to the development of restrictive compensation mechanisms in the development of symmetrical postural control. Postural control deficits may occur due to limited use of the affected scapula in individuals with FSHD. Accordingly, in cases with FSHD, there is the use of atypical movements for balance and mobility. It is not yet known whether people with FSHD really have poorer dynamic stability during self-initiated whole-body movements such as walking, and at what stage of the disease these difficulties arise. Accordingly, the aim of this study was to examine the effects of rehabilitation approaches applied to the upper limb on upper limb function, balance and walking in patients with FSHD. H1: Within the group of patients with FSHD patients underwent surgery arthrodesis surgery scapulothoracic applied to pre-treatment with the parameters of the rehabilitation program for the evaluation of upper limb functionality after applying the upper extremities, postural control and gait parameters examined, there is statistical difference between the groups.
Status | Completed |
Enrollment | 36 |
Est. completion date | June 10, 2022 |
Est. primary completion date | April 23, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - Individuals to be included in all groups 18-50 years - Score between 0.5 and 3.5 according to CSS (Clinical Severity Score) of the cases to be included in the intervention groups. - Be rated between 3-5 according to FAS (functional ambulation scale) of the cases to be included in intervention groups - For patients who will be included in the intervention group who have undergone surgery, bilateral scapulothoracic arthrodesis surgery within 3 months at the earliest - Individuals who will be included in the control group consisting of healthy individuals have not undergone any orthopedic surgery Exclusion Criteria: - Having received regular physiotherapy for 1 month, at least 2 days a week in the last 6 months - Presence of additional neurological problem/problems - Presence of any other upper limb problem/problems and surgery - Presence of lower limb problems/problems that can cause balance and walking problems - Having undergone Spinal fusion surgery - Having lower back pain described 6 and above according to VAS (Visual Analog Scale) in intervention and control groups - Having a level of visual and auditory problems that will prevent communication |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul University-Cerrahpasa | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Istanbul University - Cerrahpasa (IUC) |
Turkey,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change from baseline 10 Meter Walk Test value at 8 weeks | 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. | baseline and every four weeks up to eight week | |
Primary | change from baseline Gait Analyzer for walking speed at 8 weeks (m/sec) | 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. | baseline and every four weeks up to eight week | |
Primary | change from baseline Gait Analyzer for step time at 8 weeks (sec) | 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. | baseline and every four weeks up to eight week | |
Primary | change from baseline Gait Analyzer for step lenght at 8 weeks (m) | 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. | baseline and every four weeks up to eight week | |
Primary | change from baseline Gait Analyzer for cadance at 8 weeks (step/min) | 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. | baseline and every four weeks up to eight week | |
Primary | change from baseline Gait Analyzer for symmetry at 8 weeks (%) | 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. | baseline and every four weeks up to eight week | |
Secondary | change from baseline Timed up and Go Test at 8 weeks | The test is a measure of dynamic equilibrium. It requires individuals to get up from a chair, walk 3 feet, turn and sit. The time from the moment the individual lifts the pelvis from the chair until he or she returns with the pelvis in the chair is recorded in seconds. | baseline and every four weeks up to eight week | |
Secondary | change from baseline Single Leg Stance Test at 8 weeks | It is used to evaluate static posture and balance control. The patient must stand unaided on one leg from the moment the other foot leaves the ground until the foot touches the ground again or the arms are separated from the hips. | baseline and every four weeks up to eight week | |
Secondary | change from baseline 30 Seconds Sit Up Test at 8 weeks | It is a test that evaluates the patient's sit-up activity, lower limb strength and dynamic balance. A 30-second period is initiated when the patient cuts the contact of his pelvis from the chair in which he is sitting. He is constantly asked to sit on the chair and get up from there within 30 seconds. It is scored by counting how many repetitions the patient applies this command within 30 seconds | baseline and every four weeks up to eight week | |
Secondary | change from baseline Hand-Held Dynamometer values at 8 weeks | It is an efficient, objective, precise and affordable alternative to muscle strength measurement. A small portable device is held by the examiner and placed towards the patient's limb during maximum isometric contraction. | baseline and every four weeks up to eight week | |
Secondary | change from baseline Pedometer values at 8 weeks | It is a proven, inexpensive system that helps to measure the steps of individuals with the help of sensors attached to the ankle. | baseline and every four weeks up to eight week | |
Secondary | change from baseline Patient Satisfaction Questionnare at 8 weeks | It is a scale in which the fifth likert scale is used and patients report their satisfaction with the results of the treatments they receive. The points given are between -2 and +2.The higher scores indicate a better result. | every four weeks up to eight week | |
Secondary | Disabilities of Arm, Shoulder and Hand | It is a questionnaire that examines the patient's ability to perform certain upper extremity activities. This questionnaire is a self-report questionnaire in which patients evaluate their difficulties and situations in daily life | baseline and every four weeks up to eight week | |
Secondary | Berg Balance Scale | This scale evaluates the static and dynamic balance by observing the patient's performance for each instruction and giving a score between 0-4. Better scores indicate better balance. | baseline and every four weeks up to eight week |
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