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Whole Body Vibration Therapy in Children With Spinal Muscular Atrophy

This study is currently recruiting participants.
Verified August 2017 by Dr Tamis Wai-mun PIN, The Hong Kong Polytechnic University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03056144
First Posted: February 17, 2017
Last Update Posted: August 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Manchester Metropolitan University
The University of Hong Kong
Information provided by (Responsible Party):
Dr Tamis Wai-mun PIN, The Hong Kong Polytechnic University
  Purpose

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 Intervention
Spinal Muscular Atrophy Type 3 Device: whole body vibration therapy

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Dr Tamis Wai-mun PIN, The Hong Kong Polytechnic University:

Primary Outcome Measures:
  • 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 [ 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.

  • 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.

  • 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


Secondary Outcome Measures:
  • logbook of compliance and comments [ Time Frame: 4 weeks ]
    record the compliance and comments during the intervention

  • Visual analogue scale [ Time Frame: 4 weeks ]
    record discomfort during the intervention in a scale of 0 to 10


Estimated Enrollment: 10
Actual Study Start Date: August 1, 2017
Estimated Study Completion Date: March 31, 2019
Estimated Primary Completion Date: March 31, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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.


  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
Information from the National Library of Medicine

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


Contacts
Contact: Tamis W Pin, PhD +852 2766 6751 tamis.pin@polyu.edu.hk

Locations
Hong Kong
The Hong Kong Polytechnic University Recruiting
Hung Hom, Hong Kong
Contact: Tamis W Pin, PhD    +852 2766 6751    tamis.pin@polyu.edu.hk   
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

Additional Information:
Publications:

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 Submitted: November 8, 2016
First Posted: February 17, 2017
Last Update Posted: August 10, 2017
Last Verified: August 2017
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:
Spinal Muscular Atrophies of Childhood
Atrophy
Muscular Atrophy
Muscular Atrophy, Spinal
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