Telerehabilitation in Proximal Muscle Weakness
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04392518|
Recruitment Status : Recruiting
First Posted : May 19, 2020
Last Update Posted : July 7, 2021
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
The aim of our study is to investigate the effectiveness of two exercise programs supervised by a physiotherapist, performed in the hospital or at their home via electronic connection in a group of LGMD and SMA patients.
One exercise session will consist of breathing, posture, dynamic core stabilization, upper and lower extremity strengthening exercises. The basic exercises from each group will be performed as 1 set of 5 repetitions at the beginning and will be gradually increased according to the tolerability of the patient.
Fourteen subjects will be enrolled this randomized controlled study. Demographic characteristics, Vignos scale, Brooke scale, Barthel index, upper extremity functional index, Nottingham Health profile, short form-36, 6 minute walk test and muscle thicknesses measured by ultrasound of certain muscles will be recorded.
|Condition or disease||Intervention/treatment||Phase|
|Telemedicine Muscular Dystrophies Proximal Myopathy||Other: exercise||Not Applicable|
Some neuromuscular diseases with myogenic or neurogenic origin present with proximal muscle weakness. These diseases preferentially affect muscles around shoulders and hips and hence are called limb girdle neuromuscular diseases (LG-NMD). Patients have difficulty in climbing stairs or hills, and reaching high shelves. The vast majority of these diseases are X-linked recessive, autosomal recessive or dominantly inherited muscular dystrophies and are called limb girdle muscular dystrophies (LGMD). Spinal muscular atrophy (SMA), a disease of motor neurons, is also characterized by progressive proximal muscle weakness. Although the diseases are progressive in both conditions, regular and proper doses of exercise starting from the early stages may delay the progression of muscle weakness and may prevent joint stiffness, and contractures.
The strengthening and aerobic exercise program increases overall wellness, condition and muscle strength in patients with neuromuscular diseases. The aerobic exercise program under supervision enhances oxidative capacity and muscle function without causing fatigue. Patients performing regular exercise program report an increase in their physical endurance, leg muscle strength and walking distance. Submaximal strengthening exercises combined with aerobic exercise are highly effective.
Regulation of the exercise program according to the needs of the patient is the most important step. Appropriate individualized exercises should be programmed by a physical medicine and rehabilitation physician and performed under the supervision of a physiotherapist in the hospital environment in order to be effective. Otherwise, success of rehabilitation and patient compliance might be reduced. With the development of technology, patients can perform exercises at their home under remote supervision by a physiotherapist via electronic connection. Therefore, the aim of our study is to investigate the effectiveness of two exercise programs supervised by a physiotherapist, performed in the hospital or at their home via electronic connection in a group of LGMD and SMA patients.
Fourteen consecutive patients from the Koç University Center for Muscle Diseases (KUCMD) diagnosed with LGMD or SMA are enrolled.
Patients followed by KUCMD outpatient clinic with proximal muscle weakness who held LGMD or SMA diagnoses will be evaluated by a physical medicine and rehabilitation physician. Demographic characteristics, Vignos scale, Brooke scale, Barthel index, upper extremity functional index, Nottingham Health profile, short form-36, 6 minute walk test and muscle thicknesses measured by ultrasound of certain muscles will be recorded. Patients will be randomized into two groups.
The first group will perform the exercises in the hospital under the supervision of a physiotherapist (Group 1: Hospital based rehabilitation group) and the second group will perform the exercises at their home under remote supervision of a physiotherapist via internet connection (Group 2: Telerehabilitation group). The exercise program will be administered 3 times in a week for 10 weeks. Patients will be examined by a blinded neurologist and functional assessments and ultrasonographic evaluations will be performed by a blinded physical medicine and rehabilitation physician before and after the rehabilitation program and at the 6th and 12th months following the completion of the rehabilitation.
One exercise session will consist of breathing, posture, dynamic core stabilization, upper and lower extremity strengthening exercises. The basic exercises from each group will be performed as 1 set of 5 repetitions at the beginning and will be gradually increased according to the tolerability of the patient. If the patient has difficulty performing the basic exercises, modifications of the relevant exercise will be applied.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||There will be two group. The first group will perform the exercises in the hospital under the supervision of a physiotherapist (Group 1: Hospital based rehabilitation group) and the second group will perform the exercises at their home under remote supervision of a physiotherapist via internet connection (Group 2: Telerehabilitation group).|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||The assessor does not know the group of the patient|
|Official Title:||Is Telerehabilitation as Effective as the Traditional Hospital-based Rehabilitation in Patients With Proximal Muscle Weakness? - A Randomized Controlled Study|
|Actual Study Start Date :||September 15, 2019|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||November 2021|
Active Comparator: Hospital based rehabilitation group
This group will perform the exercises in the hospital under the supervision of a physiotherapist
Breathing, posture, dynamic core stabilization, upper and lower extremity strengthening exercises.
Active Comparator: Telerehabilitation group
This group will perform the exercises at their home under remote supervision of a physiotherapist via internet connection
Breathing, posture, dynamic core stabilization, upper and lower extremity strengthening exercises.
- 6 minute walk test [ Time Frame: 6 months ]This is a field test evaluating submaximal aerobic capacity. The individuals are asked to walk as far as possible in a 30-meter corridor in 6 minutes. The technical standards are defined by European Respiratory Society and American Thoracic Society. Six minute walking distance will be recorded. Higher walking distance shows better outcome.
- Vignos scale [ Time Frame: 6 months ]Vignos scale evaluates the functionality of the lower extremity and walking ability. This scale evaluates the patient's ability to standup from the chair, as well as to walk assisted with a long leg device in patients who can't walk without help. 1 indicates the best condition, 10 indicates the worst.
- Brooke scale [ Time Frame: 6 months ]Brooke scale evaluates the functionality of the upper extremity and hand skills ranging between 1- 6. 1 indicates the best condition, 6 indicates the worst.
- Barthel index [ Time Frame: 6 months ]Barthel index is a scale including ten items to assess functional disability. It is used to measure the performance of the individuals in daily life activities and the degree of care the patient needs in daily activities. 4. Total score is obtained by summing scores of 10 items. 0 indicates the worst, 100 indicates the best results.
- Nottingham health profile [ Time Frame: 6 months ]Nottingham health profile is a self-reported quality-of-life questionnaire. It consists of 38 items and evaluates 6 dimensions related to general health: energy, pain, emotional reactions, sleep, social isolation and physical activity. It is scored between 0-100 separately for each section. 0 indicates the best condition, 100 indicates the worst. The sum of the sub-scores gives the total Nottingham Health Profile score.
- The upper extremity functional index [ Time Frame: 6 months ]The upper extremity functional index. It consists of 20 items: each item is scored between 0 (extreme difficulty/inability to perform) and 4 (no difficulty) depending on the ability to perform specific activities. Total score is obtained by summing scores of 20 items. 0 indicates the worst, 80 indicates the best functional status.
- Short form - 36 [ Time Frame: 6 months ]Short form - 36 measures health related quality of life. It is a self-reported survey that evaluates individual health status with eight parameters consisting of physical function, pain, role limitations attributed to physical problems, role limitations attributed to emotional problems, mental health, social functioning, energy/ vitality, general health perception. There is not a summary score, each section is scored between 0-100, 0 indicates the worst condition, 100 indicates the best.
- Muscle size and quality [ Time Frame: 6 months ]All ultrasound evaluations will be performed using a MyLab Class C ultrasonic imaging system equipped with a 4-13-MHZ linear-array or 55 mm convex array according to the depth of the muscle. No compression to the skin will be applied. Evaluations will be performed by the same physiatrist who is blinded to the allocation groups. Measurements will be performed on the most affected side. Muscles assessed are supraspinatus, deltoid, biseps brachi for upper extremity; transversus abdominis, internal and external oblique for trunk; gluteus medius, quadriceps (rectus femoris, vastus intermedius, vastus lateralis, vastus medialis), medial gastrocnemius and hamstring muscles (semimembranosus, semitendinosus, biceps femoris) for the lower extremity. Qualitative analysis of all muscles will be performed using Heckmatt scale based on muscle echogenicity, grade 1 indicates normal, grade 4 the worst.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 50 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- To be older than 18 years
- To have proximal muscle weakness with a diagnosis of LGMD of any kind and SMA
- To have ability to walk independently
- history of cervical and lumbar radiculopathy
- history of cerebrovascular disease
- history of spinal cord injury
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04392518
|Contact: Ihsan Solaroglu, Prof||+ 90 212 338 10 firstname.lastname@example.org|
|Contact: Baris Ata, Prof||+ 90 212 338 10 email@example.com|
|Koc University School of Medicine||Recruiting|
|İstanbul, Turkey, 34010|
|Contact: Ihsan Solaroglu, Prof + 90 212 338 10 39 firstname.lastname@example.org|
|Contact: Baris Ata, Prof + 90 212 338 10 39 email@example.com|
|Sub-Investigator: Ozden Ozyemisci Taskiran, Prof|
|Sub-Investigator: Zeynep Turan, MD|
|Principal Investigator: Piraye Oflazer, Prof|
|Sub-Investigator: Ebru Nur Yavuz, Assoc Prof|
|Principal Investigator:||Piraye Oflazer, Prof||Koc University School of Medicine|
|Responsible Party:||Koç University|
|Other Study ID Numbers:||
|First Posted:||May 19, 2020 Key Record Dates|
|Last Update Posted:||July 7, 2021|
|Last Verified:||July 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Plan Description:||It was not planned to share individual participant data|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
proximal muscle weakness
spinal muscular atrophy
Muscular Disorders, Atrophic
Nervous System Diseases
Genetic Diseases, Inborn