Trial Outcomes & Findings for Effect of Vibration Therapy on Bone in Persons With Sub-acute Spinal Cord Injury (NCT NCT00886145)

Results Overview

Volumetric Bone Mineral Density of the Right and Left Distal Tibia as Determined by Peripheral Quantitative Computed Tomography

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

The Percent Change in vBMD from Baseline to 6 months after Mechanical Stimulation Vibration Therapy

Results posted on

2016-04-28

Participant milestones
Measure	Vibration: Right Leg and No Vibration: Left Leg The subjects will undergo vibration intervention in the seated position, 5 sessions a week, each session lasting 20 minutes for 6 months. All footwear will be removed, but they may wear socks or be barefoot. Only the right leg will be vibrated and the left leg will serve as a control. The frequency and force of the vibrations will be approximately 35 Hz and 0.3 g. In additional load of 50lbs will be added to both legs by using an extra wide strap equipped with bungee cords.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Effect of Vibration Therapy on Bone in Persons With Sub-acute Spinal Cord Injury

Baseline characteristics by cohort
Measure	Vibration- Right Leg and No Vibration-left Leg n=1 Participants The subjects will undergo a mechanical vibration intervention (Juvent Vibrating plate) in the seated position, with a load of 50lbs will be added to the right leg by using an extra wide strap equipped with bungee cords, 5 sessions a week, and each session lasting 20 minutes for a total of 6 month. At each vibration training session, the left leg will serve as a control with a load of 50lbs added to the left leg using an extra wide strap equipped with bungee cords, 5 sessions a week, and each session lasting 20 minutes for a total of 6 month.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants

Timeframe: The Percent Change in vBMD from Baseline to 6 months after Mechanical Stimulation Vibration Therapy

Volumetric Bone Mineral Density of the Right and Left Distal Tibia as Determined by Peripheral Quantitative Computed Tomography

Outcome measures
Measure	Vibration- Right Leg n=1 Participants Vibration- right leg: The subjects will undergo a mechanical vibration intervention (Juvent Vibrating plate) in the seated position, with a load of 50lbs will be added to the right leg by using an extra wide strap equipped with bungee cords, 5 sessions a week, and each session lasting 20 minutes for a total of 6 month.	No Vibration- Left Leg n=1 Participants No Vibration-left leg: At each vibration training session, the left leg will serve as a control with a load of 50lbs added to the left leg using an extra wide strap equipped with bungee cords, 5 sessions a week, and each session lasting 20 minutes for a total of 6 month.
Percent Change From Baseline in Volumetric Bone Mineral Density (vBMD) at 6-Months	-11 Percent Change	-5.7 Percent Change

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events
Measure	Vibration- Right Leg: n=1 participants at risk Vibration- right leg: The subjects will undergo a mechanical vibration intervention (Juvent Vibrating plate) in the seated position, with a load of 50lbs will be added to the right leg by using an extra wide strap equipped with bungee cords, 5 sessions a week, and each session lasting 20 minutes for a total of 6 month.	No Vibration-left Leg: n=1 participants at risk No Vibration-left leg: At each vibration training session, the left leg will serve as a control with a load of 50lbs added to the left leg using an extra wide strap equipped with bungee cords, 5 sessions a week, and each session lasting 20 minutes for a total of 6 month.
Nervous system disorders Autonomic Dysreflexia	100.0% 1/1 • Number of events 1 • 1.5 years	100.0% 1/1 • Number of events 1 • 1.5 years

Adverse event data not reported

James J. Peters VA Medical Center

Phone: 718-584-9000