The Impact of Early ADL Participation on Functional Outcomes Post Distal Radius Fracture
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Michigan Hand Questionnaire
研究概览
简要总结
This study is a randomized controlled trial (RCT). This RCT which will study the effect of performing daily activities early after a distal radius fracture being treated conservatively in a cast. This study will have two groups. The experimental group will watch a video and be given a handout on how to perform daily activities with the hand of the injured wrist while in a cast and cast care. The control group will watch a video on cast care and be given a handout on cast care. Outcome measures will be taken at initial evaluation between 0-3 weeks, at 6 weeks, at 9 weeks, and at 3 months. Outcome measures will include the Michigan Wrist Evaluation, Visual Analog Pain Scale, Tampa Scale of Kinesiophobia-11 Scale, finger mobility testing, grip and pinch strength, and the 9 hole peg test to test fine motor coordination. Outcome measure scores will be compared between groups using a t-test statistical test. Outcome measure scores will also be tested within groups using a paired t-test.
详细描述
- The surgeon will recruit patients who have met inclusion and exclusion criteria utilizing a recruitment statement.
- If the patient is interested in participating in the study, the surgeon will obtain informed consent and email a copy of the informed consent form to the patient.
- Once informed consent is obtained, the surgeon will ask the front desk to give him an envelop which will include a letter with either the word control or experimental group on it. Once the surgeon reads the letter, the subject will receive either the standard of care video and handout (control) or the intervention video and handout (experimental).
- If the subject receives the intervention then the surgeon will play the intervention video in the office and review with the subject the educational handout. The handout will be given to the subject to take home and a link to the handout and video will be emailed to the subject.
- If the subject is in the control group then the surgeon will play the standard of care (cast care) video in the office and review with the subject the cast care handout. The handout will be given to the subject to take home and a link to the handout and video will be emailed to the subject.
The following data collection procedures will occur with the subjects
The surgeon will collect data from all subjects at 0-3 weeks post injury and data collection will include: age, gender, race, hand dominance, side injured, fracture severity, workers comp status, comorbidities, smoker status, work status, and household assistance. The hand surgeon will also collect data from the subjects on their current level of function, pain, and fear of moving their injured limb.
At 6 weeks the surgeon will collect data from all subjects on their current level of function, pain, fear of moving their injured limb. The surgeon will also measure finger motion.
At 9 weeks the surgeon will collect data from all subjects on their current level of function, pain, fear of moving their injured limb. The surgeon will also measure finger motion, grip, pinch strength and fine motor coordination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •English Speaking
- •DRFs treated with a cast
- •Individuals over the age of 18
- •Less than 3 weeks from DRF
排除标准
- •Individuals with pre-existing neurological conditions affecting the upper limb
- •Individuals with cognitive deficits that would limit the ability to correctly report information on outcome measures
- •Individuals with psychological deficits which would limit the ability to correctly report information on outcome measures
- •Individuals with multiple injuries to the affected upper limb
- •Individuals with multiple injuries to both upper limbs
- •Individuals requiring surgery to fixate the distal radius fracture
- •Prior distal radius fracture involving the same wrist
- •Individuals receiving hand therapy for another injury at enrollment into study
研究组 & 干预措施
ADL video/Cast Care
ADL/cast care instructional video ADL/cast care handout
干预措施: ADL/Cast Care instruction (Behavioral)
ADL video/Cast Care
ADL/cast care instructional video ADL/cast care handout
干预措施: Cast Care Instruction (Behavioral)
Cast Care Video
Cast care instructional video Cast care handout
干预措施: Cast Care Instruction (Behavioral)
结局指标
主要结局
Michigan Hand Questionnaire
时间窗: 3 months
Patient reported outcome measure for function, min value-0 max value-100 , higher score is best possible ability
Grip and Pinch Strength
时间窗: 3 months
Jamar grip gauge testing and pinchmeter gauge testing for strength. Min score=0, higher score indicates more strength
9 hole peg test
时间窗: 3 months
fine motor coordination/sensorimotor test. Timed test therefore a longer time to complete reflects reduced finger dexterity
Tampa Scale of Kinesiophobia
时间窗: 3 months
patient reported outcome measure for fear of movement, min score=11 max score=44, higher score indicates more kinesiophobia
Visual Analog Scale
时间窗: 3 months
patient reported outcome measure for pain intensity, max value=100, min value=0, higher score is more pain
Range of motion of digits
时间窗: 3 months
distance from digits to distal palmar crease, min score=0, score of 0 signifies that the individual can touch the palm
Michigan Hand Questionnaire
时间窗: baseline
Patient reported outcome measure for function, min value-0 max value-100 , higher score is best possible ability
Michigan Hand Questionnaire
时间窗: 6 weeks
Patient reported outcome measure for function, min value-0 max value-100 , higher score is best possible ability
Michigan Hand Questionnaire
时间窗: 9 weeks
Patient reported outcome measure for function, min value-0 max value-100 , higher score is best possible ability
Visual Analog Scale
时间窗: baseline
patient reported outcome measure for pain intensity, max value=100, min value=0, higher score is more pain
Visual Analog Scale
时间窗: 6 weeks
patient reported outcome measure for pain intensity, max value=100, min value=0, higher score is more pain
Visual Analog Scale
时间窗: 9 weeks
patient reported outcome measure for pain intensity, max value=100, min value=0, higher score is more pain
Tampa Scale of Kinesiophobia
时间窗: baseline
patient reported outcome measure for fear of movement, min score=11 max score=44, higher score indicates more kinesiophobia
Tampa Scale of Kinesiophobia
时间窗: 6 weeks
patient reported outcome measure for fear of movement, min score=11 max score=44, higher score indicates more kinesiophobia
Tampa Scale of Kinesiophobia
时间窗: 9 weeks
patient reported outcome measure for fear of movement, min score=11 max score=44, higher score indicates more kinesiophobia
Range of motion of digits
时间窗: 6 weeks
distance from digits to distal palmar crease, min score=0, score of 0 signifies that the individual can touch the palm
Range of motion of digits
时间窗: 9 weeks
distance from digits to distal palmar crease, min score=0, score of 0 signifies that the individual can touch the palm
Grip and Pinch Strength
时间窗: 9 weeks
Jamar grip gauge testing and pinchmeter gauge testing for strength. Min score=0, higher score indicates more strength
9 hole peg test
时间窗: 9 weeks
fine motor coordination/sensorimotor test. Timed test therefore a longer time to complete reflects reduced finger dexterity
次要结局
未报告次要终点
研究者
Sarah Doerrer
Assistant Professor
George Washington University