Whole Body Vibration Therapy in Children With Spinal Muscular Atrophy

• Sponsor: The Hong Kong Polytechnic University
• Collaborators: Manchester Metropolitan University; The University of Hong Kong
• Information provided by (Responsible Party): Dr Tamis Wai-mun PIN, The Hong Kong Polytechnic University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Spinal Muscular Atrophy Type 3	Device: whole body vibration therapy	Not Applicable

  Show Detailed Description

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1 participants
• Intervention Model: Single Group Assignment
• Intervention Model Description: A pilot study with a before and after study design
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of Whole Body Vibration Therapy on Muscle Function, Gross Motor Function and Bone Mineral Density in Children With Spinal Muscular Atrophy - a Feasibility Study
• Actual Study Start Date: August 1, 2017
• Actual Primary Completion Date: July 12, 2018
• Actual Study Completion Date: July 12, 2018

Arms and Interventions

Arm

Intervention/treatment

Experimental: Intervention group; 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; The whole body vibration therapy regime is as follows: Day Vibration 1 Rest 1 Vibration 2 Rest 2 Vibration 3 Rest 3; st 1 min;12Hz 3 min 1 min;12Hz 3 min 1 min;15Hz 3 min; nd 1 min;15Hz 3 min 1 min;15Hz 3 min 2 min;15Hz 3 min; th 2 min;15Hz 3 min 3 min;15Hz 3 min 3 min;15Hz 3 min; 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.

Outcome Measures

Primary Outcome Measures :

1. North Star Ambulatory Assessment [ Time Frame: 4 weeks ]
   examine the gross motor function of the participants. A summed score will be added from each test item.
2. 2-minute walk test [ Time Frame: 4 weeks ]
   assess submaximal exercise capacity by measuring the distance covered in the 2 minutes in metres
3. Segmental Assessment of Trunk Control [ Time Frame: 4 weeks ]
   assess the segmental trunk control in sitting position with an ordinal score will be given in static, active and reactive level.
4. Pediatric Evaluation of Disability Inventory [ Time Frame: 4 weeks ]
   assess functional capacities in the domains of daily activities, mobility and social/cognitive function with a summary score in each domain.
5. Body height [ Time Frame: 4 weeks ]
   measure height in cm
6. Body weight [ Time Frame: 4 weeks ]
   measure weight in kilograms
7. Body mass index [ Time Frame: 4 weeks ]
   calculated based on body height and weight in terms of kg/m2
8. Bone mineral content of femur [ Time Frame: 4 weeks ]
   Distal femur BMC will be measured in grams
9. Bone mineral content of whole body (excluding head) [ Time Frame: 4 weeks ]
   Whole body (excluding head) BMC will be measured in grams
10. Areal bone mineral density of femur [ Time Frame: 4 weeks ]
    Areal bone mineral density of femur will be measured in grams/cm2
11. Areal bone mineral density of total body (excluding head) [ Time Frame: 4 weeks ]
    Areal bone mineral density of total body (excluding head) will be measured in grams/cm2
12. Volumetric bone mineral density of lumbar spine [ Time Frame: 4 weeks ]
    Volumetric bone mineral density of lumbar spine (L2 to L4) in grams/cm3
13. Range of right hip flexion [ Time Frame: 4 weeks ]
    measure hip flexion in supine using goniometer in degrees
14. Range of left hip flexion [ Time Frame: 4 weeks ]
    measure hip flexion in supine using goniometer in degrees
15. Range of right hip extension [ Time Frame: 4 weeks ]
    measure hip extension in prone using goniometer in degrees
16. Range of left hip extension [ Time Frame: 4 weeks ]
    measure hip extension in prone using goniometer in degrees
17. Range of right hip abduction [ Time Frame: 4 weeks ]
    measure hip abduction in supine using goniometer in degrees
18. Range of left hip abduction [ Time Frame: 4 weeks ]
    measure hip abduction in supine using goniometer in degrees
19. Range of right knee flexion [ Time Frame: 4 weeks ]
    measure knee flexion in prone using goniometer in degrees
20. Range of left knee flexion [ Time Frame: 4 weeks ]
    measure knee flexion in prone using goniometer in degrees
21. Range of right knee extension [ Time Frame: 4 weeks ]
    measure knee extension in sitting using goniometer in degrees
22. Range of left knee extension [ Time Frame: 4 weeks ]
    measure knee extension in sitting using goniometer in degrees
23. Range of right ankle dorsiflexion [ Time Frame: 4 weeks ]
    measure ankle dorsiflexion in sitting using goniometer in degrees
24. Range of left ankle dorsiflexion [ Time Frame: 4 weeks ]
    measure ankle dorsiflexion in sitting using goniometer in degrees
25. Range of right ankle plantarflexion [ Time Frame: 4 weeks ]
    measure ankle plantarflexion in sitting using goniometer in degrees
26. Range of left ankle plantarflexion [ Time Frame: 4 weeks ]
    measure ankle plantarflexion in sitting using goniometer in degrees
27. Muscle strength of right hip flexors [ Time Frame: 4 weeks ]
    measure muscle strength of hip flexors in supine using dynamometer in terms of Newton
28. Muscle strength of left hip flexors [ Time Frame: 4 weeks ]
    measure muscle strength of hip flexors in supine using dynamometer in terms of Newton
29. Muscle strength of right hip extensors [ Time Frame: 4 weeks ]
    measure muscle strength of hip extensors in prone using dynamometer in terms of Newton
30. Muscle strength of left hip extensors [ Time Frame: 4 weeks ]
    measure muscle strength of hip extensors in prone using dynamometer in terms of Newton
31. Muscle strength of right knee flexors [ Time Frame: 4 weeks ]
    measure muscle strength of knee flexors in sitting using dynamometer in terms of Newton
32. Muscle strength of left knee flexors [ Time Frame: 4 weeks ]
    measure muscle strength of knee flexors in sitting using dynamometer in terms of Newton
33. Muscle strength of right knee extensors [ Time Frame: 4 weeks ]
    measure muscle strength of knee extensors in sitting using dynamometer in terms of Newton
34. Muscle strength of left knee extensors [ Time Frame: 4 weeks ]
    measure muscle strength of knee extensors in sitting using dynamometer in terms of Newton
35. Muscle strength of right hip abductors [ Time Frame: 4 weeks ]
    measure muscle strength of hip abductors in supine using dynamometer in terms of Newton
36. Muscle strength of left hip abductors [ Time Frame: 4 weeks ]
    measure muscle strength of hip abductors in supine using dynamometer in terms of Newton
37. Muscle strength of right ankle dorsiflexors [ Time Frame: 4 weeks ]
    measure muscle strength of ankle dorsiflexors in sitting using dynamometer in terms of Newton
38. Muscle strength of left ankle dorsiflexors [ Time Frame: 4 weeks ]
    measure muscle strength of ankle dorsiflexors in sitting using dynamometer in terms of Newton
39. Muscle strength of right ankle plantarflexors [ Time Frame: 4 weeks ]
    measure muscle strength of ankle plantarflexors in sitting using dynamometer in terms of Newton
40. Muscle strength of left ankle plantarflexors [ Time Frame: 4 weeks ]
    measure muscle strength of ankle plantarflexors in sitting using dynamometer in terms of Newton

Secondary Outcome Measures :

1. logbook of compliance and comments [ Time Frame: 4 weeks ]
   record the compliance and comments during the intervention
2. Visual analogue scale [ Time Frame: 4 weeks ]
   record discomfort during the intervention in a scale of 0 to 10

Eligibility Criteria

• Ages Eligible for Study: 6 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

Hong Kong

The Hong Kong Polytechnic University

Hung Hom, Hong Kong

Sponsors and Collaborators

The Hong Kong Polytechnic University

Manchester Metropolitan University

The University of Hong Kong

Investigators

• Principal Investigator: Tamis W Pin, PhD; The Hong Kong Polytechnic University

More Information

Publications:

Vry J, Schubert IJ, Semler O, Haug V, Schönau 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.

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.

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.

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. Review.

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. Review.

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.

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.

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

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. Review.

Rehn B, Lidström J, Skoglund J, Lindström 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. Epub 2006 Aug 10. Review.

Matute-Llorente A, González-Agüero A, Gómez-Cabello A, Vicente-Rodríguez G, Casajús Mallén 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. Review.

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.

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.

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.

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

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.

Söderpalm 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.

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. Epub 2004 Jan 27.

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.

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.

• Responsible Party: Dr Tamis Wai-mun PIN, Assistant Professor, The Hong Kong Polytechnic University
• ClinicalTrials.gov Identifier: NCT03056144 History of Changes
• Other Study ID Numbers: YBPA
• First Posted: February 17, 2017
• Last Update Posted: October 10, 2018
• Last Verified: October 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr Tamis Wai-mun PIN, The Hong Kong Polytechnic University:

spinal muscular atrophy; total body vibration; children

Additional relevant MeSH terms:

Atrophy; Muscular Atrophy; Muscular Atrophy, Spinal; Spinal Muscular Atrophies of Childhood; Pathological Conditions, Anatomical; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; Neuromuscular Diseases; Heredodegenerative Disorders, Nervous System; Genetic Diseases, Inborn