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Clinical Trials/NCT02998021
NCT02998021
Completed
N/A

Effect of Vibration Exercise on Upper Limb Strength, Function, and Pain

Alicia Koontz1 site in 1 country10 target enrollmentMarch 15, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Spinal Cord Injuries
Sponsor
Alicia Koontz
Enrollment
10
Locations
1
Primary Endpoint
Changes in Functional Shoulder Pain
Status
Completed
Last Updated
6 years ago

Overview

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 .

Registry
clinicaltrials.gov
Start Date
March 15, 2017
End Date
November 20, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Alicia Koontz
Responsible Party
Sponsor Investigator
Principal Investigator

Alicia Koontz

Associate Professor

University of Pittsburgh

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

Outcomes

Primary Outcomes

Changes in Functional Shoulder Pain

Time Frame: Baseline and 12 weeks

Score generated by the Wheelchair Users Shoulder Pain Index. Participants self report shoulder pain over the past week while performing activities of daily living. Scores range from 1 to 150 where higher scores represent higher levels of pain.

Change in Strength

Time Frame: Baseline and 12 weeks

Measurement of peak torque (Nm/kg) for Shoulder Adduction. Measurement was done using the Biodex System.

Change in Upper Extremity Pain

Time Frame: Baseline and 12 weeks

Score generated by the Numerical Rating Scale for shoulder pain. Participants self report upper extremity pain over the last 24 hours with scores on a 0 to 10 scale. Higher scores represent higher levels of pain.

Change in General Health Measures

Time Frame: Baseline and 12 weeks

Score generated by the Short Form 36 walk-wheel. Participants self report on health questions within 8 domains each of which are scored from 0 to 100. The scores from each of the subscales are then averaged together to obtain an overall total score. A score of 0 represents the worst possible health state and a score of 100 represents the best possible health state.

Secondary Outcomes

  • Change in Acceleration(Baseline and 12 weeks)
  • Change in Peak Force(Baseline and 12 weeks)
  • Change in Mechanical Effective Force(Baseline and 12 weeks)
  • Wheelchair Transfer Ability(Baseline and 12 weeks)
  • Power Output(Baseline and 12 weeks)
  • Change in Peak Speed(Baseline and 12 weeks)

Study Sites (1)

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