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临床试验/NCT02998021
NCT02998021已完成不适用

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

Alicia Koontz1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2017年3月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
试验地点
1
主要终点
Change in Strength

研究概览

简要总结

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.

详细描述

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 .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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

研究组 & 干预措施

Resistance Training - Vibrating Dumbbell

Experimental

Study participants who are randomized into the vibration exercise group will complete an in-home exercise program using a vibrating dumbbell.

干预措施: Vibrating Dumbbell (Device)

Resistance Training - Standard Dumbbell

Active Comparator

Study participants who are randomized into the control exercise group will complete an in-home exercise program using standard dumbbells.

干预措施: Standard Dumbbell (Device)

结局指标

主要结局

Change in Strength

时间窗: Baseline and 12 weeks

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

Changes in Functional Shoulder Pain

时间窗: 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 Upper Extremity Pain

时间窗: 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

时间窗: 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.

次要结局

  • 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)

研究者

发起方
Alicia Koontz
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Alicia Koontz

Associate Professor

University of Pittsburgh

研究点 (1)

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