Whole Body Vibration Therapy in Children With Spinal Muscular Atrophy

NCT03056144 | Terminated Results

• 1 other identifier: YBPA
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal muscular atrophy (SMA) are one of the common physical disabilities in childhood. For SMA, progressive muscle weakness and early fatigue hamper the mobility of the sufferers. Osteopenia is common for this population group due to poor bone growth and muscle disuse. As a result, non-traumatic related fractures and bone pain are common. Recently, whole body vibration therapy (WBVT) has been proven to improve bone health and muscle function in healthy adults and post-menopausal women. Among the limited studies on the WBVT for children with muscular dystrophies, promising results have been shown on gross motor function, balance, and muscle strength and the WBVT appears to be safe for children with SMA. The present pilot study is designed to investigate if WBVT is safe and feasible for individuals with SMA and if WBVT can improve muscle function, functional abilities, postural control and bone mineral density in children with SMA. Convenience samples of 10 individuals with SMA type III will be recruited. The participants will receive the WBVT of 25 Hertz and a peak-to-peak amplitude of 4mm for a session of about 18 minutes, 3 days per week for 4 weeks. Assessment will be performed at the baseline and the completion of the intervention to examine the muscle function, functional abilities, postural control and bone mineral density of the participants. It is anticipated that the outcomes of this pilot study for SMA may show if this intervention is safe, feasible and beneficial for children with SMA type III regarding to muscle function, functional abilities, postural control and bone mineral content and if there may be any related practical issues of this intervention to this population group. The outcomes also provide research evidence to clinicians if this intervention should be recommended to individuals of similar problems.

Conditions

Spinal Muscular Atrophy Type 3

Keywords

spinal muscular atrophy; total body vibration; children

Outcome Measures

Primary Outcomes (42)

• North Star Ambulatory Assessment

  examine the gross motor function of the participants. A summed score will be added from each test item.

  4 weeks

• 2-minute Walk Test

  assess submaximal exercise capacity by measuring the distance covered in the 2 minutes in metres

  4 weeks

• Segmental Assessment of Trunk Control-static

  assess the segmental trunk control in sitting position with an ordinal score will be given in static trunk control. Assessment score represents as follows: 1= learning head control, 2= learning upper thoracic control, 3= learning mid-thoracic control, 4= learning lower thoracic control, 5= learning at upper lumber control, 6= learning lower lumbar control, 7= learning full trunk control and 8= achieved full trunk control.

  4 weeks

• Pediatric Evaluation of Disability Inventory

  assess functional capacities in the domains of self care, mobility and social function with a summary score in each domain. A dichotomous score will be given to each question in each domain: 0= unable and 1= able. In self care domain, there are 73 questions, i.e. maximal score is 73. In mobility domain, there are 59 questions i.e. maximal score is 59. In social function domain, there are 65 questions i.e. maximal score is 65.

  4 weeks

• Body Height

  measure height in cm

  4 weeks

• Body Weight

  measure weight in kilograms

  4 weeks

• Body Mass Index

  calculated based on body height and weight in terms of kg/m2

  4 weeks

• Bone Mineral Content of Femur

  Distal femur BMC will be measured in grams

  4 weeks

• Bone Mineral Content of Whole Body (Excluding Head)

  Whole body (excluding head) BMC will be measured in grams

  4 weeks

• Areal Bone Mineral Density of Femur

  Areal bone mineral density of femur will be measured in grams/cm2

  4 weeks

• Areal Bone Mineral Density of Total Body (Excluding Head)

  Areal bone mineral density of total body (excluding head) will be measured in grams/cm2

  4 weeks

• Volumetric Bone Mineral Density of Lumbar Spine

  Volumetric bone mineral density of lumbar spine (L2 to L4) in grams/cm3

  4 weeks

• Range of Right Hip Flexion

  measure hip flexion in supine using goniometer in degrees

  4 weeks

• Range of Left Hip Flexion

  measure hip flexion in supine using goniometer in degrees

  4 weeks

• Range of Right Hip Extension

  measure hip extension in prone using goniometer in degrees

  4 weeks

• Range of Left Hip Extension

  measure hip extension in prone using goniometer in degrees

  4 weeks

• Range of Right Hip Abduction

  measure hip abduction in supine using goniometer in degrees

  4 weeks

• Range of Left Hip Abduction

  measure hip abduction in supine using goniometer in degrees

  4 weeks

• Range of Right Knee Flexion

  measure knee flexion in prone using goniometer in degrees

  4 weeks

• Range of Left Knee Flexion

  measure knee flexion in prone using goniometer in degrees

  4 weeks

• Range of Right Knee Extension

  measure knee extension in sitting using goniometer in degrees

  4 weeks

• Range of Left Knee Extension

  measure knee extension in sitting using goniometer in degrees

  4 weeks

• Range of Right Ankle Dorsiflexion

  measure ankle dorsiflexion in sitting using goniometer in degrees

  4 weeks

• Range of Left Ankle Dorsiflexion

  measure ankle dorsiflexion in sitting using goniometer in degrees

  4 weeks

• Range of Right Ankle Plantarflexion

  measure ankle plantarflexion in sitting using goniometer in degrees

  4 weeks

• Range of Left Ankle Plantarflexion

  measure ankle plantarflexion in sitting using goniometer in degrees

  4 weeks

• Muscle Strength of Right Hip Flexors

  measure muscle strength of hip flexors in supine using dynamometer in terms of Newton

  4 weeks

• Muscle Strength of Left Hip Flexors

  measure muscle strength of hip flexors in supine using dynamometer in terms of Newton

  4 weeks

• Muscle Strength of Right Hip Extensors

  measure muscle strength of hip extensors in prone using dynamometer in terms of Newton

  4 weeks

• Muscle Strength of Left Hip Extensors

  measure muscle strength of hip extensors in prone using dynamometer in terms of Newton

  4 weeks

• Muscle Strength of Right Knee Flexors

  measure muscle strength of knee flexors in sitting using dynamometer in terms of Newton

  4 weeks

• Muscle Strength of Left Knee Flexors

  measure muscle strength of knee flexors in sitting using dynamometer in terms of Newton

  4 weeks

• Muscle Strength of Right Knee Extensors

  measure muscle strength of knee extensors in sitting using dynamometer in terms of Newton

  4 weeks

• Muscle Strength of Left Knee Extensors

  measure muscle strength of knee extensors in sitting using dynamometer in terms of Newton

  4 weeks

• Muscle Strength of Right Hip Abductors

  measure muscle strength of hip abductors in supine using dynamometer in terms of Newton

  4 weeks

• Muscle Strength of Left Hip Abductors

  measure muscle strength of hip abductors in supine using dynamometer in terms of Newton

  4 weeks

• Muscle Strength of Right Ankle Dorsiflexors

  measure muscle strength of ankle dorsiflexors in sitting using dynamometer in terms of Newton

  4 weeks

• Muscle Strength of Left Ankle Dorsiflexors

  measure muscle strength of ankle dorsiflexors in sitting using dynamometer in terms of Newton

  4 weeks

• Muscle Strength of Right Ankle Plantarflexors

  measure muscle strength of ankle plantarflexors in sitting using dynamometer in terms of Newton

  4 weeks

• Muscle Strength of Left Ankle Plantarflexors

  measure muscle strength of ankle plantarflexors in sitting using dynamometer in terms of Newton

  4 weeks

• Segmental Assessment of Trunk Control_active

  assess the segmental trunk control in sitting position with an ordinal score will be given in active trunk control. Assessment score represents as follows: 1= learning head control, 2= learning upper thoracic control, 3= learning mid-thoracic control, 4= learning lower thoracic control, 5= learning at upper lumber control, 6= learning lower lumbar control, 7= learning full trunk control and 8= achieved full trunk control.

  4 weeks

• Segmental Assessment of Trunk Control-reactive

  assess the segmental trunk control in sitting position with an ordinal score will be given in reactive trunk control. Assessment score represents as follows: 1= learning head control, 2= learning upper thoracic control, 3= learning mid-thoracic control, 4= learning lower thoracic control, 5= learning at upper lumber control, 6= learning lower lumbar control, 7= learning full trunk control and 8= achieved full trunk control.

  4 weeks

Secondary Outcomes (2)

• Percentage of Attendance of Participants

  4 weeks

• Visual Analogue Scale

  4 weeks

Study Arms (1)

Intervention group

EXPERIMENTAL

The participants will undergo the whole body vibration therapy 1 session per day, 3 days per week for 4 weeks. The whole total whole body therapy session will last 18 minutes with 9 minutes of vibration.

Device: whole body vibration therapy

Interventions

whole body vibration therapy DEVICE

The whole body vibration therapy regime is as follows: Day Vibration 1 Rest 1 Vibration 2 Rest 2 Vibration 3 Rest 3 1. st 1 min;12Hz 3 min 1 min;12Hz 3 min 1 min;15Hz 3 min 2. nd 1 min;15Hz 3 min 1 min;15Hz 3 min 2 min;15Hz 3 min 3. th 2 min;15Hz 3 min 3 min;15Hz 3 min 3 min;15Hz 3 min 4. th 2 min;24-25Hz 3 min 2 min;24-25Hz 3 min 2 min;24-25Hz 3 min \>5th 3 min;24-25Hz 3 min 3 min;24-25Hz 3 min 3 min;24-25Hz 3 min The participants will perform mini-squats during Vibrations 1 and 3 and weight-shifting between right and left legs during Vibration 2 on the vibration platform under the supervision of a trained research assistant.

Intervention group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of type III spinal muscular atrophy
• Be able to stand on the vibration platform with or without support
• Be able to undertake clinical examination and DXA evaluation
• Informed consent by the participant's parent/ guardian

You may not qualify if:

• There is a history of fracture within 8 weeks of enrolment of the present study and acute thrombosis, muscle or tendon inflammation, renal stones, discopathy or arthritis as reported by their parent/ guardian.
• There is a history of using any of the following medications, regardless of dose, for at least 1 month, within 3 months of enrolment into the present study: anabolic agents, or growth hormone.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Manchester Metropolitan University: collaborator
• The University of Hong Kong: collaborator

Study Sites (1)

The Hong Kong Polytechnic University

Hung Hom, Hong Kong

Location

Related Publications (20)

• Vry J, Schubert IJ, Semler O, Haug V, Schonau E, Kirschner J. Whole-body vibration training in children with Duchenne muscular dystrophy and spinal muscular atrophy. Eur J Paediatr Neurol. 2014 Mar;18(2):140-9. doi: 10.1016/j.ejpn.2013.09.005. Epub 2013 Oct 11.

  PMID: 24157400 BACKGROUND

• Henderson RC, Kairalla JA, Barrington JW, Abbas A, Stevenson RD. Longitudinal changes in bone density in children and adolescents with moderate to severe cerebral palsy. J Pediatr. 2005 Jun;146(6):769-75. doi: 10.1016/j.jpeds.2005.02.024.

  PMID: 15973316 BACKGROUND

• Stevenson RD, Conaway M, Barrington JW, Cuthill SL, Worley G, Henderson RC. Fracture rate in children with cerebral palsy. Pediatr Rehabil. 2006 Oct-Dec;9(4):396-403. doi: 10.1080/13638490600668061.

  PMID: 17111566 BACKGROUND

• Mergler S, Evenhuis HM, Boot AM, De Man SA, Bindels-De Heus KG, Huijbers WA, Penning C. Epidemiology of low bone mineral density and fractures in children with severe cerebral palsy: a systematic review. Dev Med Child Neurol. 2009 Oct;51(10):773-8. doi: 10.1111/j.1469-8749.2009.03384.x. Epub 2009 Jul 8.

  PMID: 19614941 BACKGROUND

• Houlihan CM, Stevenson RD. Bone density in cerebral palsy. Phys Med Rehabil Clin N Am. 2009 Aug;20(3):493-508. doi: 10.1016/j.pmr.2009.04.004.

  PMID: 19643349 BACKGROUND

• Henderson RC, Lark RK, Gurka MJ, Worley G, Fung EB, Conaway M, Stallings VA, Stevenson RD. Bone density and metabolism in children and adolescents with moderate to severe cerebral palsy. Pediatrics. 2002 Jul;110(1 Pt 1):e5. doi: 10.1542/peds.110.1.e5.

  PMID: 12093986 BACKGROUND

• Larson CM, Henderson RC. Bone mineral density and fractures in boys with Duchenne muscular dystrophy. J Pediatr Orthop. 2000 Jan-Feb;20(1):71-4.

  PMID: 10641693 BACKGROUND

• Rauch F. Vibration therapy. Dev Med Child Neurol. 2009 Oct;51 Suppl 4:166-8. doi: 10.1111/j.1469-8749.2009.03418.x.

  PMID: 19740225 BACKGROUND

• Jordan MJ, Norris SR, Smith DJ, Herzog W. Vibration training: an overview of the area, training consequences, and future considerations. J Strength Cond Res. 2005 May;19(2):459-66. doi: 10.1519/13293.1.

  PMID: 15903391 BACKGROUND

• Rehn B, Lidstrom J, Skoglund J, Lindstrom B. Effects on leg muscular performance from whole-body vibration exercise: a systematic review. Scand J Med Sci Sports. 2007 Feb;17(1):2-11. doi: 10.1111/j.1600-0838.2006.00578.x. Epub 2006 Aug 10.

  PMID: 16903900 BACKGROUND

• Matute-Llorente A, Gonzalez-Aguero A, Gomez-Cabello A, Vicente-Rodriguez G, Casajus Mallen JA. Effect of whole-body vibration therapy on health-related physical fitness in children and adolescents with disabilities: a systematic review. J Adolesc Health. 2014 Apr;54(4):385-96. doi: 10.1016/j.jadohealth.2013.11.001. Epub 2014 Jan 1.

  PMID: 24388109 BACKGROUND

• El-Shamy SM. Effect of whole-body vibration on muscle strength and balance in diplegic cerebral palsy: a randomized controlled trial. Am J Phys Med Rehabil. 2014 Feb;93(2):114-21. doi: 10.1097/PHM.0b013e3182a541a4.

  PMID: 24434887 BACKGROUND

• Unger M, Jelsma J, Stark C. Effect of a trunk-targeted intervention using vibration on posture and gait in children with spastic type cerebral palsy: a randomized control trial. Dev Neurorehabil. 2013;16(2):79-88. doi: 10.3109/17518423.2012.715313.

  PMID: 23477461 BACKGROUND

• Novotny SA, Mader TL, Greising AG, Lin AS, Guldberg RE, Warren GL, Lowe DA. Low intensity, high frequency vibration training to improve musculoskeletal function in a mouse model of Duchenne muscular dystrophy. PLoS One. 2014 Aug 14;9(8):e104339. doi: 10.1371/journal.pone.0104339. eCollection 2014.

  PMID: 25121503 BACKGROUND

• Chelly J, Desguerre I. Progressive muscular dystrophies. Handb Clin Neurol. 2013;113:1343-66. doi: 10.1016/B978-0-444-59565-2.00006-X.

  PMID: 23622359 BACKGROUND

• Myers KA, Ramage B, Khan A, Mah JK. Vibration therapy tolerated in children with Duchenne muscular dystrophy: a pilot study. Pediatr Neurol. 2014 Jul;51(1):126-9. doi: 10.1016/j.pediatrneurol.2014.03.005. Epub 2014 Apr 4.

  PMID: 24830767 BACKGROUND

• Soderpalm AC, Kroksmark AK, Magnusson P, Karlsson J, Tulinius M, Swolin-Eide D. Whole body vibration therapy in patients with Duchenne muscular dystrophy--a prospective observational study. J Musculoskelet Neuronal Interact. 2013 Mar;13(1):13-8.

  PMID: 23445910 BACKGROUND

• Ward K, Alsop C, Caulton J, Rubin C, Adams J, Mughal Z. Low magnitude mechanical loading is osteogenic in children with disabling conditions. J Bone Miner Res. 2004 Mar;19(3):360-9. doi: 10.1359/JBMR.040129. Epub 2004 Jan 27.

  PMID: 15040823 BACKGROUND

• Mazzone E, Bianco F, Main M, van den Hauwe M, Ash M, de Vries R, Fagoaga Mata J, Stein S, De Sanctis R, D'Amico A, Palermo C, Fanelli L, Scoto MC, Mayhew A, Eagle M, Vigo M, Febrer A, Korinthenberg R, de Visser M, Bushby K, Muntoni F, Goemans N, Sormani MP, Bertini E, Pane M, Mercuri E. Six minute walk test in type III spinal muscular atrophy: a 12month longitudinal study. Neuromuscul Disord. 2013 Aug;23(8):624-8. doi: 10.1016/j.nmd.2013.06.001. Epub 2013 Jul 1.

  PMID: 23809874 BACKGROUND

• Noto Y, Misawa S, Mori M, Kawaguchi N, Kanai K, Shibuya K, Isose S, Nasu S, Sekiguchi Y, Beppu M, Ohmori S, Nakagawa M, Kuwabara S. Prominent fatigue in spinal muscular atrophy and spinal and bulbar muscular atrophy: evidence of activity-dependent conduction block. Clin Neurophysiol. 2013 Sep;124(9):1893-8. doi: 10.1016/j.clinph.2012.12.053. Epub 2013 Apr 30.

  PMID: 23643309 BACKGROUND

Related Links

• Farooq FT, Holcik M, MacKenzie A. Spinal Muscular Atrophy: Classification, Diagnosis, Background, Molecular Mechanism and Development of Therapeutics 2013.

MeSH Terms

Conditions

Spinal Muscular Atrophies of Childhood; Muscular Atrophy, Spinal

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr Tamis W Pin
• Organization: The Hong Kong Polytechnic University

tamis.pin@polyu.edu.hk

85227666751

Study Officials

• Tamis W Pin, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A pilot study with a before and after study design

Study Record Dates

• First Submitted: November 8, 2016
• First Posted: February 17, 2017
• Study Start: August 1, 2017
• Primary Completion: July 12, 2018
• Study Completion: July 12, 2018
• Last Updated: July 26, 2019
• Results First Posted: July 26, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)