Clinical trial NCT02998021: Effect of Vibration Exercise on Upper Limb Strength, Function, and Pain
Official title: Effect of Vibration Exercise on Upper Limb Strength, Function, and Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2016-12-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The primary purpose of this study is to explore the benefits of vibration dumbbell resistance training over standard dumbbell resistance training for improving upper limb strength, function and pain among manual wheelchair users with paraplegia.

Detailed description: Objectives: The primary purpose of this study is to explore the benefits of vibration dumbbell resistance training over standard dumbbell resistance training for improving upper limb strength, function and pain among manual wheelchair users with paraplegia.

Experimental Design: Design: Randomized Control Trial

Methods: Twenty subjects with paraplegia will be recruited and randomized into two groups, a vibration dumbbell training (V-DT) group and a standard dumbbell training group (S-DT). Both groups will participate in a supervised 12-week (3 sessions per week) dumbbell (free-weight) strength training program consisting of nine exercises specifically designed to improve upper limb muscle function to support propulsion and transfer activities and protect the shoulders from developing pain. For each of the nine exercises the vibration group will hold a high-frequency (40 Hz) vibrating dumbbell in a static arm posture (isometric training) while the control group will move a non-vibrating dumbbell through the full range of motion for a given exercise (isotonic training). Both groups will follow a standardized protocol for assessing and progressing the amount of weight that is added to the dumbbell to achieve optimal training effects.

All participants will participate in laboratory testing for various outcome measures at baseline, 6 weeks and 12 weeks .

Eligibility criteria: Inclusion Criteria:

* have a neurological impairment secondary to spinal cord injury (SCI) or disease at T2 or lower
* greater than 6 months post injury
* use a manual wheelchair as primary means of mobility (at least 30 hrs. per week)
* 18 to 65 years of age
* provide signed medical release by primary care physician to engage in a high-intensity resistance training exercise program
* live within 60 minutes driving time (1 hour) from the research center
* able to perform a transfer independently to and from a wheelchair
* have normal range of motion in the upper limbs.

Exclusion Criteria:

* history of fractures or dislocations in the shoulder, elbow and wrist from which the subject has not fully recovered or joint replacement of any of the joints in the upper extremities
* upper limb pain that interferes with the ability to propel or transfer
* recent hospitalization for any reason (within the past three months)
* pregnant women
* history of coronary artery disease, coronary bypass surgery or other cardio-respiratory events

Primary outcomes:
measure: Change in Strength
timeFrame: Baseline and 12 weeks
measure: Change in Upper Extremity Pain
timeFrame: Baseline and 12 weeks
measure: Change in General Health Measures
timeFrame: Baseline and 12 weeks
measure: Changes in Functional Shoulder Pain
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change in Peak Speed
timeFrame: Baseline and 12 weeks
measure: Change in Acceleration
timeFrame: Baseline and 12 weeks
measure: Change in Peak Force
timeFrame: Baseline and 12 weeks
measure: Change in Mechanical Effective Force
timeFrame: Baseline and 12 weeks
measure: Wheelchair Transfer Ability
timeFrame: Baseline and 12 weeks
measure: Power Output
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Alicia Koontz, PhD
role: PRINCIPAL_INVESTIGATOR
References: