TelemedicineNCT04392518
Telerehabilitation in Proximal Muscle Weakness
A study testing exercise in people with Telemedicine and Muscular Dystrophies, run by Koç University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Telemedicine, Muscular Dystrophies, Proximal Myopathy
- What is being tested?
- exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2019to Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- history of cervical and lumbar radiculopathy
- history of cerebrovascular disease
- history of spinal cord injury
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Koc University School of Medicine
Istanbul, 34010
Ihsan Solaroglu, Prof, + 90 212 338 10 39, isolaroglu@ku.edu.tr
Baris Ata, Prof, + 90 212 338 10 39, bata@ku.edu.tr
About this study
Official title: Is Telerehabilitation as Effective as the Traditional Hospital-based Rehabilitation in Patients With Proximal Muscle Weakness? - A Randomized Controlled Study
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.
Read the detailed description
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.
- Conditions
- Telemedicine, Muscular Dystrophies, Proximal Myopathy
- Being tested
- exercise
- Keywords
- telerehabilitation, telehealth, muscular dystrophy, proximal muscle weakness, spinal muscular atrophy, telemedicine
- Medical subject headings
- Muscular Dystrophies, Muscular Atrophy, Spinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
Breathing, posture, dynamic core stabilization, upper and lower extremity strengthening exercises.
| Study group | Role | What they receive |
|---|---|---|
| Hospital based rehabilitation group | Active comparator | This group will perform the exercises in the hospital under the supervision of a physiotherapist Receives: Other: exercise |
| Telerehabilitation group | Active comparator | This group will perform the exercises at their home under remote supervision of a physiotherapist via internet connection Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minute walk test
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.
Measured: 6 months
Secondary outcomes (7)
Vignos scale
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.
Measured: 6 months
Brooke scale
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.
Measured: 6 months
Barthel index
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.
Measured: 6 months
Nottingham health profile
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.
Measured: 6 months
The upper extremity functional index
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.
Measured: 6 months
Short form - 36
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.
Measured: 6 months
Muscle size and quality
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start15 Sep 2019
- Primary completionSep 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for TelemedicineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Piraye Oflazer, Prof, Principal investigator, Koc University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04392518
- Sponsor's protocol ID
- 2018.150.IRB.1.017
- Status last verified
- Jul 2021
- First submitted
- 13 May 2020
- Last updated
- 7 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It was not planned to share individual participant data
Publications
Vissing J. Limb girdle muscular dystrophies: classification, clinical spectrum and emerging therapies. Curr Opin Neurol. 2016 Oct;29(5):635-41. doi: 10.1097/WCO.0000000000000375.
PubMed 27490667Siciliano G, Simoncini C, Giannotti S, Zampa V, Angelini C, Ricci G. Muscle exercise in limb girdle muscular dystrophies: pitfall and advantages. Acta Myol. 2015 May;34(1):3-8.
PubMed 26155063Narayanaswami P, Weiss M, Selcen D, David W, Raynor E, Carter G, Wicklund M, Barohn RJ, Ensrud E, Griggs RC, Gronseth G, Amato AA; Guideline Development Subcommittee of the American Academy of Neurology; Practice Issues Review Panel of the American Association of Neuromuscular & Electrodiagnostic Medicine. Evidence-based guideline summary: diagnosis and treatment of limb-girdle and distal dystrophies [RETIRED]: report of the guideline development subcommittee of the American Academy of Neurology and the practice issues review panel of the American Association of Neuromuscular & Electrodiagnostic Medicine. Neurology. 2014 Oct 14;83(16):1453-63. doi: 10.1212/WNL.0000000000000892.
PubMed 25313375Berthelsen MP, Husu E, Christensen SB, Prahm KP, Vissing J, Jensen BR. Anti-gravity training improves walking capacity and postural balance in patients with muscular dystrophy. Neuromuscul Disord. 2014 Jun;24(6):492-8. doi: 10.1016/j.nmd.2014.03.001. Epub 2014 Mar 12.
PubMed 24684860Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30.
PubMed 25359355VIGNOS PJ Jr, SPENCER GE Jr, ARCHIBALD KC. Management of progressive muscular dystrophy in childhood. JAMA. 1963 Apr 13;184:89-96. doi: 10.1001/jama.1963.03700150043007. No abstract available.
PubMed 13997180Brooke MH, Griggs RC, Mendell JR, Fenichel GM, Shumate JB, Pellegrino RJ. Clinical trial in Duchenne dystrophy. I. The design of the protocol. Muscle Nerve. 1981 May-Jun;4(3):186-97. doi: 10.1002/mus.880040304. No abstract available.
PubMed 7017401Collin C, Wade DT, Davies S, Horne V. The Barthel ADL Index: a reliability study. Int Disabil Stud. 1988;10(2):61-3. doi: 10.3109/09638288809164103.
PubMed 3403500Kucukdeveci AA, McKenna SP, Kutlay S, Gursel Y, Whalley D, Arasil T. The development and psychometric assessment of the Turkish version of the Nottingham Health Profile. Int J Rehabil Res. 2000 Mar;23(1):31-8. doi: 10.1097/00004356-200023010-00004.
PubMed 10826123Aytar A, Yuruk ZO, Tuzun EH, Baltaci G, Karatas M, Eker L. The Upper Extremity Functional Index (UEFI): cross-cultural adaptation, reliability, and validity of the Turkish version. J Back Musculoskelet Rehabil. 2015;28(3):489-95. doi: 10.3233/BMR-140545.
PubMed 25322741Demiral Y, Ergor G, Unal B, Semin S, Akvardar Y, Kivircik B, Alptekin K. Normative data and discriminative properties of short form 36 (SF-36) in Turkish urban population. BMC Public Health. 2006 Oct 9;6:247. doi: 10.1186/1471-2458-6-247.
PubMed 17029646Ware JE: Scoring the SF-36. SF-36 Health Survey: Manual and Interpretation Guide 1993
Heckmatt JZ, Leeman S, Dubowitz V. Ultrasound imaging in the diagnosis of muscle disease. J Pediatr. 1982 Nov;101(5):656-60. doi: 10.1016/s0022-3476(82)80286-2.
PubMed 7131136Cho J, Lee K, Kim M, Hahn J, Lee W. The Effects of Double Oscillation Exercise Combined with Elastic Band Exercise on Scapular Stabilizing Muscle Strength and Thickness in Healthy Young Individuals: A Randomized Controlled Pilot Trial. J Sports Sci Med. 2018 Mar 1;17(1):7-16. eCollection 2018 Mar.
PubMed 29535573Jenkins ND, Miller JM, Buckner SL, Cochrane KC, Bergstrom HC, Hill EC, Smith CM, Housh TJ, Cramer JT. Test-Retest Reliability of Single Transverse versus Panoramic Ultrasound Imaging for Muscle Size and Echo Intensity of the Biceps Brachii. Ultrasound Med Biol. 2015 Jun;41(6):1584-91. doi: 10.1016/j.ultrasmedbio.2015.01.017. Epub 2015 Mar 3.
PubMed 25746907
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Telerehabilitation as Effective as the Traditional Hospital-based Rehabilitation in Patients With Proximal Muscle Weakness? - A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04392518
- Acronym / sponsor ID
- 2018.150.IRB.1.017
- Conditions
- Telemedicine, Muscular Dystrophies, Proximal Myopathy
- Keywords
- telerehabilitation, telehealth, muscular dystrophy, proximal muscle weakness, spinal muscular atrophy, telemedicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Hospital based rehabilitation group | Active comparator | Other: exerciseThis group will perform the exercises in the hospital under the supervision of a physiotherapist |
| Telerehabilitation group | Active comparator | Other: exerciseThis group will perform the exercises at their home under remote supervision of a physiotherapist via internet connection |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- history of cervical and lumbar radiculopathy
- history of cerebrovascular disease
- history of spinal cord injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exerciseBreathing, posture, dynamic core stabilization, upper and lower extremity strengthening exercises. | Other | Hospital based rehabilitation group, Telerehabilitation group |
Primary outcome
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.
7 secondary outcomes
Vignos scale
Time frame: 6 months
Brooke scale
Time frame: 6 months
Barthel index
Time frame: 6 months
Nottingham health profile
Time frame: 6 months
The upper extremity functional index
Time frame: 6 months
Short form - 36
Time frame: 6 months
Muscle size and quality
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Results publication: PubMed 27490667Vissing J. Limb girdle muscular dystrophies: classification, clinical spectrum and emerging therapies. Curr Opin Neurol. 2016 Oct;29(5):635-41. doi: 10.1097/WCO.0000000000000375.
- Results publication: PubMed 26155063Siciliano G, Simoncini C, Giannotti S, Zampa V, Angelini C, Ricci G. Muscle exercise in limb girdle muscular dystrophies: pitfall and advantages. Acta Myol. 2015 May;34(1):3-8.
- Results publication: PubMed 25313375Narayanaswami P, Weiss M, Selcen D, David W, Raynor E, Carter G, Wicklund M, Barohn RJ, Ensrud E, Griggs RC, Gronseth G, Amato AA; Guideline Development Subcommittee of the American Academy of Neurology; Practice Issues Review Panel of the American Association of Neuromuscular & Electrodiagnostic Medicine. Evidence-based guideline summary: diagnosis and treatment of limb-girdle and distal dystrophies [RETIRED]: report of the guideline development subcommittee of the American Academy of Neurology and the practice issues review panel of the American Association of Neuromuscular & Electrodiagnostic Medicine. Neurology. 2014 Oct 14;83(16):1453-63. doi: 10.1212/WNL.0000000000000892.
- Results publication: PubMed 24684860Berthelsen MP, Husu E, Christensen SB, Prahm KP, Vissing J, Jensen BR. Anti-gravity training improves walking capacity and postural balance in patients with muscular dystrophy. Neuromuscul Disord. 2014 Jun;24(6):492-8. doi: 10.1016/j.nmd.2014.03.001. Epub 2014 Mar 12.
- Results publication: PubMed 25359355Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30.
- Results publication: PubMed 13997180VIGNOS PJ Jr, SPENCER GE Jr, ARCHIBALD KC. Management of progressive muscular dystrophy in childhood. JAMA. 1963 Apr 13;184:89-96. doi: 10.1001/jama.1963.03700150043007. No abstract available.
- Results publication: PubMed 7017401Brooke MH, Griggs RC, Mendell JR, Fenichel GM, Shumate JB, Pellegrino RJ. Clinical trial in Duchenne dystrophy. I. The design of the protocol. Muscle Nerve. 1981 May-Jun;4(3):186-97. doi: 10.1002/mus.880040304. No abstract available.
- Results publication: PubMed 3403500Collin C, Wade DT, Davies S, Horne V. The Barthel ADL Index: a reliability study. Int Disabil Stud. 1988;10(2):61-3. doi: 10.3109/09638288809164103.
- Results publication: PubMed 10826123Kucukdeveci AA, McKenna SP, Kutlay S, Gursel Y, Whalley D, Arasil T. The development and psychometric assessment of the Turkish version of the Nottingham Health Profile. Int J Rehabil Res. 2000 Mar;23(1):31-8. doi: 10.1097/00004356-200023010-00004.
- Results publication: PubMed 25322741Aytar A, Yuruk ZO, Tuzun EH, Baltaci G, Karatas M, Eker L. The Upper Extremity Functional Index (UEFI): cross-cultural adaptation, reliability, and validity of the Turkish version. J Back Musculoskelet Rehabil. 2015;28(3):489-95. doi: 10.3233/BMR-140545.
- Results publication: PubMed 17029646Demiral Y, Ergor G, Unal B, Semin S, Akvardar Y, Kivircik B, Alptekin K. Normative data and discriminative properties of short form 36 (SF-36) in Turkish urban population. BMC Public Health. 2006 Oct 9;6:247. doi: 10.1186/1471-2458-6-247.
- Results publicationWare JE: Scoring the SF-36. SF-36 Health Survey: Manual and Interpretation Guide 1993
- Individual participant dataSharing planned: No. It was not planned to share individual participant data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Piraye Oflazer, Prof principal investigator
Koc University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Telemedicine and Muscular Dystrophies, run by Koç University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ihsan Solaroglu, Prof (+ 90 212 338 10 39, isolaroglu@ku.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 minute walk test (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04392518, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021.