Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06251206
Status:
RECRUITING
Last Update Posted:
2024-02-12
First Post:
2024-02-01
Brief Title:
Impact of Early ADL Education on Outcomes Post DRF ORIF
Sponsor:
George Washington University
Organization:
George Washington University
Study Overview
Official Title:
Impact of Early Multimodal ADL Education on Outcomes Post Distal Radius Fracture Open Reduction Internal Fixation Surgery
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 with surgical intervention of open reduction and internal fixation 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 recovering from surgery and postoperative instructions The control group will watch a video on wound care and be given a handout on postoperative instructions Outcome measures will be taken at initial evaluation between 1-2 weeks post surgery at 5-7 weeks post surgery at 8-10 weeks and at 12-14 weeks 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
Detailed Description:
1 The surgeon will recruit patients who have had surgery for a distal radius fracture with open reduction and internal fixation and have met inclusion and exclusion criteria utilizing a recruitment statement
2 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
3 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
4 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
5 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 which includes a QR code to the educational video
If the subject is in the control group then the surgeon will play the standard of care postoperative care video in the office and review with the subject the postoperative care handout The handout will be given to the subject to take home which includes a QR code to the video
The following data collection procedures will occur with the subjects
The surgeon will collect data from all subjects at 1-2 weeks post surgery 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 5-7 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 8-10 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 12-14 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 14 weeks If 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
2 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
3 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
4 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
5 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 which includes a QR code to the educational video
If the subject is in the control group then the surgeon will play the standard of care postoperative care video in the office and review with the subject the postoperative care handout The handout will be given to the subject to take home which includes a QR code to the video
The following data collection procedures will occur with the subjects
The surgeon will collect data from all subjects at 1-2 weeks post surgery 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 5-7 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 8-10 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 12-14 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 14 weeks If 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None