Whole Body Vibration Therapy in Children With Spinal Muscular Atrophy
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ClinicalTrials.gov Identifier: NCT03056144 |
Recruitment Status :
Terminated
(All potential participants opt to a simultaneous pharmacological clinical trial)
First Posted : February 17, 2017
Results First Posted : July 26, 2019
Last Update Posted : July 26, 2019
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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 |
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Spinal Muscular Atrophy Type 3 | Device: whole body vibration therapy | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1 participants |
Allocation: | N/A |
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 |

Arm | Intervention/treatment |
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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.
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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
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. |
- 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-minute Walk Test [ Time Frame: 4 weeks ]assess submaximal exercise capacity by measuring the distance covered in the 2 minutes in metres
- Segmental Assessment of Trunk Control-static [ Time Frame: 4 weeks ]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.
- Pediatric Evaluation of Disability Inventory [ Time Frame: 4 weeks ]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.
- Body Height [ Time Frame: 4 weeks ]measure height in cm
- Body Weight [ Time Frame: 4 weeks ]measure weight in kilograms
- Body Mass Index [ Time Frame: 4 weeks ]calculated based on body height and weight in terms of kg/m2
- Bone Mineral Content of Femur [ Time Frame: 4 weeks ]Distal femur BMC will be measured in grams
- Bone Mineral Content of Whole Body (Excluding Head) [ Time Frame: 4 weeks ]Whole body (excluding head) BMC will be measured in grams
- Areal Bone Mineral Density of Femur [ Time Frame: 4 weeks ]Areal bone mineral density of femur will be measured in grams/cm2
- 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
- Volumetric Bone Mineral Density of Lumbar Spine [ Time Frame: 4 weeks ]Volumetric bone mineral density of lumbar spine (L2 to L4) in grams/cm3
- Range of Right Hip Flexion [ Time Frame: 4 weeks ]measure hip flexion in supine using goniometer in degrees
- Range of Left Hip Flexion [ Time Frame: 4 weeks ]measure hip flexion in supine using goniometer in degrees
- Range of Right Hip Extension [ Time Frame: 4 weeks ]measure hip extension in prone using goniometer in degrees
- Range of Left Hip Extension [ Time Frame: 4 weeks ]measure hip extension in prone using goniometer in degrees
- Range of Right Hip Abduction [ Time Frame: 4 weeks ]measure hip abduction in supine using goniometer in degrees
- Range of Left Hip Abduction [ Time Frame: 4 weeks ]measure hip abduction in supine using goniometer in degrees
- Range of Right Knee Flexion [ Time Frame: 4 weeks ]measure knee flexion in prone using goniometer in degrees
- Range of Left Knee Flexion [ Time Frame: 4 weeks ]measure knee flexion in prone using goniometer in degrees
- Range of Right Knee Extension [ Time Frame: 4 weeks ]measure knee extension in sitting using goniometer in degrees
- Range of Left Knee Extension [ Time Frame: 4 weeks ]measure knee extension in sitting using goniometer in degrees
- Range of Right Ankle Dorsiflexion [ Time Frame: 4 weeks ]measure ankle dorsiflexion in sitting using goniometer in degrees
- Range of Left Ankle Dorsiflexion [ Time Frame: 4 weeks ]measure ankle dorsiflexion in sitting using goniometer in degrees
- Range of Right Ankle Plantarflexion [ Time Frame: 4 weeks ]measure ankle plantarflexion in sitting using goniometer in degrees
- Range of Left Ankle Plantarflexion [ Time Frame: 4 weeks ]measure ankle plantarflexion in sitting using goniometer in degrees
- Muscle Strength of Right Hip Flexors [ Time Frame: 4 weeks ]measure muscle strength of hip flexors in supine using dynamometer in terms of Newton
- Muscle Strength of Left Hip Flexors [ Time Frame: 4 weeks ]measure muscle strength of hip flexors in supine using dynamometer in terms of Newton
- Muscle Strength of Right Hip Extensors [ Time Frame: 4 weeks ]measure muscle strength of hip extensors in prone using dynamometer in terms of Newton
- Muscle Strength of Left Hip Extensors [ Time Frame: 4 weeks ]measure muscle strength of hip extensors in prone using dynamometer in terms of Newton
- Muscle Strength of Right Knee Flexors [ Time Frame: 4 weeks ]measure muscle strength of knee flexors in sitting using dynamometer in terms of Newton
- Muscle Strength of Left Knee Flexors [ Time Frame: 4 weeks ]measure muscle strength of knee flexors in sitting using dynamometer in terms of Newton
- Muscle Strength of Right Knee Extensors [ Time Frame: 4 weeks ]measure muscle strength of knee extensors in sitting using dynamometer in terms of Newton
- Muscle Strength of Left Knee Extensors [ Time Frame: 4 weeks ]measure muscle strength of knee extensors in sitting using dynamometer in terms of Newton
- Muscle Strength of Right Hip Abductors [ Time Frame: 4 weeks ]measure muscle strength of hip abductors in supine using dynamometer in terms of Newton
- Muscle Strength of Left Hip Abductors [ Time Frame: 4 weeks ]measure muscle strength of hip abductors in supine using dynamometer in terms of Newton
- Muscle Strength of Right Ankle Dorsiflexors [ Time Frame: 4 weeks ]measure muscle strength of ankle dorsiflexors in sitting using dynamometer in terms of Newton
- Muscle Strength of Left Ankle Dorsiflexors [ Time Frame: 4 weeks ]measure muscle strength of ankle dorsiflexors in sitting using dynamometer in terms of Newton
- Muscle Strength of Right Ankle Plantarflexors [ Time Frame: 4 weeks ]measure muscle strength of ankle plantarflexors in sitting using dynamometer in terms of Newton
- Muscle Strength of Left Ankle Plantarflexors [ Time Frame: 4 weeks ]measure muscle strength of ankle plantarflexors in sitting using dynamometer in terms of Newton
- Segmental Assessment of Trunk Control_active [ Time Frame: 4 weeks ]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.
- Segmental Assessment of Trunk Control-reactive [ Time Frame: 4 weeks ]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.
- Percentage of Attendance of Participants [ Time Frame: 4 weeks ]record the percentage of attendance and comments during the intervention
- Visual Analogue Scale [ Time Frame: 4 weeks ]record discomfort during the intervention in a scale of 0 (no discomfort) to 10 (maximal discomfort).

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

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): NCT03056144
Hong Kong | |
The Hong Kong Polytechnic University | |
Hung Hom, Hong Kong |
Principal Investigator: | Tamis W Pin, PhD | The Hong Kong Polytechnic University |
Documents provided by Dr Tamis Wai-mun PIN, The Hong Kong Polytechnic University:
Publications:
Responsible Party: | Dr Tamis Wai-mun PIN, Assistant Professor, The Hong Kong Polytechnic University |
ClinicalTrials.gov Identifier: | NCT03056144 |
Other Study ID Numbers: |
YBPA |
First Posted: | February 17, 2017 Key Record Dates |
Results First Posted: | July 26, 2019 |
Last Update Posted: | July 26, 2019 |
Last Verified: | July 2019 |
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 |
spinal muscular atrophy total body vibration children |
Muscular Atrophy Muscular Atrophy, Spinal Atrophy Pathological Conditions, Anatomical Neuromuscular Manifestations Neurologic Manifestations |
Nervous System Diseases Spinal Cord Diseases Central Nervous System Diseases Motor Neuron Disease Neurodegenerative Diseases Neuromuscular Diseases |