Telerehabilitation in Proximal Muscle Weakness

NCT04392518 | Unknown

• 1 other identifier: 2018.150.IRB.1.017
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Telemedicine; Muscular Dystrophies; Proximal Myopathy

Keywords

telerehabilitation; telehealth; muscular dystrophy; proximal muscle weakness; spinal muscular atrophy; telemedicine

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (7)

• Vignos scale

  6 months

• Brooke scale

  6 months

• Barthel index

  6 months

• Nottingham health profile

  6 months

• The upper extremity functional index

  6 months

Study Arms (2)

Hospital based rehabilitation group

ACTIVE COMPARATOR

This group will perform the exercises in the hospital under the supervision of a physiotherapist

Other: exercise

Telerehabilitation group

ACTIVE COMPARATOR

This group will perform the exercises at their home under remote supervision of a physiotherapist via internet connection

Other: exercise

Interventions

exercise OTHER

Breathing, posture, dynamic core stabilization, upper and lower extremity strengthening exercises.

Hospital based rehabilitation group; Telerehabilitation group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• history of cervical and lumbar radiculopathy
• history of cerebrovascular disease
• history of spinal cord injury

Sponsors & Collaborators

• Koç University: lead

Study Sites (1)

Koc University School of Medicine

Istanbul, 34010, Turkey (Türkiye)

RECRUITING

Related Publications (20)

• 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.

  PMID: 27490667 RESULT

• Siciliano 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.

  PMID: 26155063 RESULT

• Narayanaswami 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.

  PMID: 25313375 RESULT

• Berthelsen 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.

  PMID: 24684860 RESULT

• Holland 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.

  PMID: 25359355 RESULT

• VIGNOS 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.

  PMID: 13997180 RESULT

• Brooke 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.

  PMID: 7017401 RESULT

• Collin 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.

  PMID: 3403500 RESULT

• Kucukdeveci 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.

  PMID: 10826123 RESULT

• Aytar 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.

  PMID: 25322741 RESULT

• Demiral 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.

  PMID: 17029646 RESULT

• Ware JE: Scoring the SF-36. SF-36 Health Survey: Manual and Interpretation Guide 1993

  RESULT

• 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.

  PMID: 7131136 RESULT

• Cho 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.

  PMID: 29535573 RESULT

• Jenkins 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.

  PMID: 25746907 RESULT

• Gnat R, Saulicz E, Miadowicz B. Reliability of real-time ultrasound measurement of transversus abdominis thickness in healthy trained subjects. Eur Spine J. 2012 Aug;21(8):1508-15. doi: 10.1007/s00586-012-2184-4. Epub 2012 Feb 12.

  PMID: 22327252 RESULT

• Whittaker JL, Emery CA. Sonographic measures of the gluteus medius, gluteus minimus, and vastus medialis muscles. J Orthop Sports Phys Ther. 2014 Aug;44(8):627-32. doi: 10.2519/jospt.2014.5315. Epub 2014 Jul 16.

  PMID: 25029916 RESULT

• Strasser EM, Draskovits T, Praschak M, Quittan M, Graf A. Association between ultrasound measurements of muscle thickness, pennation angle, echogenicity and skeletal muscle strength in the elderly. Age (Dordr). 2013 Dec;35(6):2377-88. doi: 10.1007/s11357-013-9517-z. Epub 2013 Mar 2.

  PMID: 23456136 RESULT

• Balius R, Pedret C, Iriarte I, Saiz R, Cerezal L. Sonographic landmarks in hamstring muscles. Skeletal Radiol. 2019 Nov;48(11):1675-1683. doi: 10.1007/s00256-019-03208-x. Epub 2019 Apr 17.

  PMID: 30997529 RESULT

• Kuyumcu ME, Halil M, Kara O, Cuni B, Caglayan G, Guven S, Yesil Y, Arik G, Yavuz BB, Cankurtaran M, Ozcakar L. Ultrasonographic evaluation of the calf muscle mass and architecture in elderly patients with and without sarcopenia. Arch Gerontol Geriatr. 2016 Jul-Aug;65:218-24. doi: 10.1016/j.archger.2016.04.004. Epub 2016 Apr 14.

  PMID: 27107379 RESULT

MeSH Terms

Conditions

Muscular Dystrophies; Muscular Atrophy, Spinal

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Spinal Cord Diseases; Central Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Piraye Oflazer, Prof

  Koc University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ihsan Solaroglu, Prof

CONTACT

+ 90 212 338 10 39; isolaroglu@ku.edu.tr

Baris Ata, Prof

CONTACT

+ 90 212 338 10 39; bata@ku.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor does not know the group of the patient
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 19, 2020
• Study Start: September 15, 2019
• Primary Completion: September 1, 2021
• Study Completion: November 1, 2021
• Last Updated: July 7, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)