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| Name | Class |
|---|---|
| American Hand Therapy Foundation | UNKNOWN |
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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.
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.
At 3 months 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.
All subjects will be followed for 3 months. If at 6 weeks or later the patient receives a referral for hand therapy it will be noted in the record. It will also be noted in the record if subject experiences any complication such as median nerve compression, tendonitis, or complex regional pain syndrome.
The outcome measures that will be used with both the control and experimental groups and at each time point that the data will be collected. All outcome measures will be uploaded onto RedCap. Subjects will use a tablet to fill out all questionnaires (Michigan Hand Evaluation, Visual Analog Scale, Tampa Scale of Kinesiophobia-11) while in the office or forms will be emailed through RedCap and scores will be uploaded into the RedCap database. All clinical tests (grip and pinch testing, distance from distal palmar crease, 9 hole peg test) will be recorded in RedCap. Demographic information will either be collected on the tablet in RedCap.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADL video/Cast Care | Experimental | ADL/cast care instructional video ADL/cast care handout |
|
| Cast Care Video | Active Comparator | Cast care instructional video Cast care handout |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADL/Cast Care instruction | Behavioral | Participants in the experimental group will watch a video instructing them on early ADL participation after DRF fracture treated in a cast and cast care. Participants in the experimental group will also receive a handout on ADL participation and cast care. |
| Measure | Description | Time Frame |
|---|---|---|
| Michigan Hand Questionnaire | Patient reported outcome measure for function, min value-0 max value-100 , higher score is best possible ability | baseline |
| Michigan Hand Questionnaire | Patient reported outcome measure for function, min value-0 max value-100 , higher score is best possible ability | 6 weeks |
| Michigan Hand Questionnaire | Patient reported outcome measure for function, min value-0 max value-100 , higher score is best possible ability | 9 weeks |
| Michigan Hand Questionnaire | Patient reported outcome measure for function, min value-0 max value-100 , higher score is best possible ability | 3 months |
| Visual Analog Scale | patient reported outcome measure for pain intensity, max value=100, min value=0, higher score is more pain | baseline |
| Visual Analog Scale | patient reported outcome measure for pain intensity, max value=100, min value=0, higher score is more pain | 6 weeks |
| Visual Analog Scale | patient reported outcome measure for pain intensity, max value=100, min value=0, higher score is more pain | 9 weeks |
| Visual Analog Scale |
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Inclusion Criteria:
English Speaking
DRFs treated with a cast
Individuals over the age of 18
Less than 3 weeks from DRF
Exclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Doerrer, PhD | Contact | 757-651-5110 | sdoerrer56@gwu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Facilities Associates | Recruiting | Washington | Virginia | 22204 | United States |
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| ID | Term |
|---|---|
| D000092503 | Wrist Fractures |
| ID | Term |
|---|---|
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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| Cast Care Instruction | Behavioral | Participants in the control group will watch a video instructing them on cast care. Participants in the control group will receive a handout on cast care. |
|
patient reported outcome measure for pain intensity, max value=100, min value=0, higher score is more pain |
| 3 months |
| Tampa Scale of Kinesiophobia | patient reported outcome measure for fear of movement, min score=11 max score=44, higher score indicates more kinesiophobia | baseline |
| Tampa Scale of Kinesiophobia | patient reported outcome measure for fear of movement, min score=11 max score=44, higher score indicates more kinesiophobia | 6 weeks |
| Tampa Scale of Kinesiophobia | patient reported outcome measure for fear of movement, min score=11 max score=44, higher score indicates more kinesiophobia | 9 weeks |
| Tampa Scale of Kinesiophobia | patient reported outcome measure for fear of movement, min score=11 max score=44, higher score indicates more kinesiophobia | 3 months |
| Range of motion of digits | distance from digits to distal palmar crease, min score=0, score of 0 signifies that the individual can touch the palm | 6 weeks |
| Range of motion of digits | distance from digits to distal palmar crease, min score=0, score of 0 signifies that the individual can touch the palm | 9 weeks |
| Range of motion of digits | distance from digits to distal palmar crease, min score=0, score of 0 signifies that the individual can touch the palm | 3 months |
| Grip and Pinch Strength | Jamar grip gauge testing and pinchmeter gauge testing for strength. Min score=0, higher score indicates more strength | 9 weeks |
| Grip and Pinch Strength | Jamar grip gauge testing and pinchmeter gauge testing for strength. Min score=0, higher score indicates more strength | 3 months |
| 9 hole peg test | fine motor coordination/sensorimotor test. Timed test therefore a longer time to complete reflects reduced finger dexterity | 9 weeks |
| 9 hole peg test | fine motor coordination/sensorimotor test. Timed test therefore a longer time to complete reflects reduced finger dexterity | 3 months |