Trial Outcomes & Findings for Whole Body Vibration Therapy in Children With Spinal Muscular Atrophy (NCT NCT03056144)

Results Overview

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

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

4 weeks

Results posted on

2019-07-26

Participant Flow

One participant was recruited and assigned for the intervention.

Participant milestones

Participant milestones
Measure	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. 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.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Group n=1 Participants 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. 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.
Age, Categorical <=18 years	1 Participants n=1 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=1 Participants
Age, Categorical >=65 years	0 Participants n=1 Participants
Age, Continuous	14 years STANDARD_DEVIATION 0 • n=1 Participants
Sex: Female, Male Female	1 Participants n=1 Participants
Sex: Female, Male Male	0 Participants n=1 Participants
Region of Enrollment Hong Kong	1 participants n=1 Participants

PRIMARY outcome

Timeframe: 4 weeks

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 4 weeks

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention Group n=1 Participants 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. 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.
Segmental Assessment of Trunk Control-static	8 score on a scale Interval 8.0 to 8.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention Group n=1 Participants 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. 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.
Pediatric Evaluation of Disability Inventory PEDI- self care	68 score on a scale Standard Deviation 0
Pediatric Evaluation of Disability Inventory PEDI- mobility	14 score on a scale Standard Deviation 0
Pediatric Evaluation of Disability Inventory PEDI- social function	64 score on a scale Standard Deviation 0

PRIMARY outcome

Timeframe: 4 weeks

measure height in cm

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 4 weeks

measure weight in kilograms

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 4 weeks

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 4 weeks

Distal femur BMC will be measured in grams

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 4 weeks

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 4 weeks

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 4 weeks

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

Outcome measures

Outcome measures
Measure	Intervention Group n=1 Participants 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. 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.
Areal Bone Mineral Density of Total Body (Excluding Head)	0.902 g/cm2 Standard Deviation 0

PRIMARY outcome

Timeframe: 4 weeks

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 4 weeks

measure hip flexion in supine using goniometer in degrees

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 4 weeks

measure hip flexion in supine using goniometer in degrees

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 4 weeks

measure hip extension in prone using goniometer in degrees

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 4 weeks

measure hip extension in prone using goniometer in degrees

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 4 weeks

measure hip abduction in supine using goniometer in degrees

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 4 weeks

measure hip abduction in supine using goniometer in degrees

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 4 weeks

measure knee flexion in prone using goniometer in degrees

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 4 weeks

measure knee flexion in prone using goniometer in degrees

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 4 weeks

measure knee extension in sitting using goniometer in degrees

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 4 weeks

measure knee extension in sitting using goniometer in degrees

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 4 weeks

measure ankle dorsiflexion in sitting using goniometer in degrees

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 4 weeks

measure ankle dorsiflexion in sitting using goniometer in degrees

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 4 weeks

measure ankle plantarflexion in sitting using goniometer in degrees

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 4 weeks

measure ankle plantarflexion in sitting using goniometer in degrees

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 4 weeks

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 4 weeks

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 4 weeks

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 4 weeks

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 4 weeks

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 4 weeks

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 4 weeks

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 4 weeks

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 4 weeks

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 4 weeks

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 4 weeks

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 4 weeks

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 4 weeks

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 4 weeks

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention Group n=1 Participants 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. 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.
Segmental Assessment of Trunk Control_active	8 score on a scale Interval 8.0 to 8.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention Group n=1 Participants 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. 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.
Segmental Assessment of Trunk Control-reactive	5 score on a scale Interval 5.0 to 5.0

SECONDARY outcome

Timeframe: 4 weeks

record the percentage of attendance and comments during the intervention

Outcome measures

Outcome measures
Measure	Intervention Group n=1 Participants 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. 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.
Percentage of Attendance of Participants	100 percentage of attendance

SECONDARY outcome

Timeframe: 4 weeks

record discomfort during the intervention in a scale of 0 (no discomfort) to 10 (maximal discomfort).

Outcome measures

Outcome measures
Measure	Intervention Group n=1 Participants 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. 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.
Visual Analogue Scale	0 score on a scale

Adverse Events

Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Tamis W Pin

The Hong Kong Polytechnic University

Phone: 85227666751

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place