Dose-Response Effects of Whole Body Vibration on Spasticity and Walking in SCI (WBV)
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|ClinicalTrials.gov Identifier: NCT02340910|
Recruitment Status : Recruiting
First Posted : January 19, 2015
Last Update Posted : August 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury||Procedure: Short Duration Procedure: Long Duration||Not Applicable|
Phase 1 of this study has been successfully completed. The results of Phase 1 indicate that a single session of WBV lasting for a total of 6 minutes (delivered in eight 45-sec bouts) at a high-frequency (50Hz) was associated with the largest decrease in spasticity (as measured by the pendulum test).
The goal for Phase 2 is to determine whether longer doses of WBV result in greater reductions in spasticity as well as improvements in walking ability. Two different doses of WBV, a short dose and a long dose, will be tested.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||57 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||Masked allocation and intervention|
|Actual Study Start Date :||January 2015|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||August 2020|
Experimental: Short duration
Short Duration WBV consists of 8 45-sec bouts of 50Hz WBV followed by a 1-minute seated rest
Procedure: Short Duration
During each WBV repetition, subjects will stand on the vibration platform of the WBV device with knees slightly bent (approximately 30 degrees flexion). The subject will hold the handrails for balance and the WBV device will be turned on. The subject will receive a total of 6 minutes of WBV at a frequency of 50 Hz.
Experimental: Long duration
Long Duration WBV consists of 16 bouts 45-sec of 50Hz WBV followed by a 1-minute seated rest
Procedure: Long Duration
During each WBV repetition, subjects will stand on the vibration platform of the WBV device with knees slightly bent (approximately 30 degrees flexion). The subject will hold the handrails for balance and the WBV device will be turned on. The subject will receive a total of 12 minutes of WBV at a frequency of 50 Hz.
Interventions will occur for 5 days a week for 4 weeks .
- Spasticity Assessments [ Time Frame: Estimated 1 hour ]Pendulum test, Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET) Questionnaire, Electrophysiological testing (Soleus H-reflex)
- Walking ability [ Time Frame: Estimated 30 minutes ]Walking speed, endurance and pattern will be assessed while wearing motion capture sensors
- Strength [ Time Frame: Estimated 20 minutes ]5 times sit to stand assessment, testing of upper leg muscle strength using force measurements
- Pain perception [ Time Frame: Estimated 20 minutes ]SCI Pain Basic Dataset Questionnaire
- Upper Extremity Tests [ Time Frame: Estimated 5 minutes ]For participants who have a cervical level of injury, pinch strength will be measured using a hand-held device and the nine-hole peg test will be used to measure hand function.
- Ankle Clonus Test/Foot [ Time Frame: Estimated 15 minutes ]Ankle spasticity will be measured using motion capture sensors to record ankle joint angles.
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): NCT02340910
|Contact: Edelle Field-Fote, PT, PhD||404-603-4274||Edelle_Field-Fote@Shepherd.org|
|Contact: Elizabeth Sasso, PT, DPT||404-350-7551||Elizabeth_sasso@shepherd.org|
|United States, Georgia|
|Shepherd Center, Inc.||Recruiting|
|Atlanta, Georgia, United States, 30309|
|Contact: Edelle Field-Fote, PT, PhD, FAPTA (404) 603-4274 Edelle_Field-Fote@Shepherd.org|
|Contact: Elizabeth Sasso, PT, DPT 404-350-7551 Elizabeth_sasso@shepherd.org|