Impact of Early ADL Education on Outcomes Post DRF ORIF

Distal Radius Fractures Clinical Trial

Official title:

Impact of Early Multimodal ADL Education on Outcomes Post Distal Radius Fracture Open Reduction Internal Fixation Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06251206
• Other study ID #: NCR235402
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 2024
• Est. completion date: September 2026

Study information

• Verified date: February 2024
• Source: George Washington University
• Contact: Sarah Doerrer, PhD
• Phone: 757-651-5110
• Email: sdoerrer56[@]gwu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 64
• Est. completion date: September 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

Inclusion Criteria:

English Speaking DRF treated with ORIF Individuals 18 years of age or older 2 weeks or less post ORIF for DRF

Exclusion Criteria:

Individuals with pre-existing neurological coniditons affecting the upper limb Individuals with congnitive 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 Prior distal radius fracture involving the same wrist Individuals receiving hand therapy for another injury at enrollment into study

Related Conditions & MeSH terms

• Distal Radius Fractures
• Radius Fractures
• Wrist Fractures

Intervention

Behavioral:
• ADL/Postoperative Instruction
This is an education video which includes demonstration of simple ADL tasks that the participant can do at home after surgery. Handout includes the same information and a QR code to watch the video.
• Postoperative Instruction
This is an education video that only includes the postoperative instructions. Handout includes the same information and a QR code to watch the video.

Locations

Country	Name	City	State
United States	Medical Facilities Associates	Washington	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
George Washington University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Michigan Hand Questionnaire	Patient reported outcome measure for function	baseline, 5-7 weeks, 8-10 weeks, 12-14 weeks
Secondary	Visual Analog Scale	patient reported outcome measure for pain intensity	baseline, 5-7 weeks, 8-10 weeks, 12-14 weeks
Secondary	Tampa Scale of Kinesiophobia	patient reported outcome measure for fear of movement	baseline, 5-7 weeks, 8-10 weeks, 12-14 weeks
Secondary	Range of Motion of digits	distance from digits to distal palmar crease in cm	5-7 weeks, 8-10 weeks, 12-14 weeks
Secondary	Grip and Pinch Strength	Jamar grip gauge testing and pinchmeter gauge testing for strength	8-10 weeks, 12-14 weeks
Secondary	9 hole peg test	fine motor coordination/sensorimotor test	8-10 weeks, 12-14 weeks