Early ADL Education for Wrist Fractures

Overseen By Sarah Doerrer, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: George Washington University

Disqualifiers: Neurological conditions, Cognitive deficits, Psychological deficits, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 12-14 weeks

64 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Early ADL Education for Wrist Fractures?

Research shows that occupation-based interventions, which include activities of daily living (ADL) education, can improve patient-reported performance and physical measures in hand therapy. This suggests that early ADL education may help patients with wrist fractures use their injured hand more effectively in real-life activities. ^{1 2 3 4 5}

How is the Early ADL Education treatment different from other treatments for wrist fractures?

Early ADL Education focuses on teaching patients how to perform daily activities safely and effectively after a wrist fracture, which is different from other treatments that may focus on surgical or physical therapy interventions. This approach aims to help patients regain independence and function in their everyday lives, which is a unique aspect compared to more traditional medical or surgical treatments. ^{1 6 7 8 9}

Eligibility Criteria

This trial is for individuals who have had surgery (open reduction and internal fixation) to fix a broken wrist, specifically the distal radius. Participants should be in the early stages of recovery and able to follow postoperative instructions.

Exclusion Criteria

I have a condition that affects my arm or hand.

I can accurately report my health status.

Individuals with psychological deficits which would limit the ability to correctly report information on outcome measures

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive educational intervention or standard care video and handout post-surgery

12-14 weeks

4 visits (in-person)

Follow-up

Participants are monitored for function, pain, and fear of movement with various outcome measures

14 weeks

4 visits (in-person)

Treatment Details

Interventions

• ADL Education

Trial Overview The study compares two approaches after wrist surgery: one group receives special education on performing daily activities with their injured hand, while the other gets standard wound care guidance. Their recovery progress will be measured at several points using various tests for pain, fear of movement, strength, and fine motor skills.

Participant Groups

Group I: ADL/Postoperative Instruction Experimental Treatment 2 Interventions

Participants in the experimental group will watch a video instructing them on early ADL participation after DRF fracture treated by ORIF and postoperative care. Participants in the experimental group will also receive a handout on ADL participation and postoperative care with a QR code to the video.

Group II: Postoperative Instruction Active Control 1 Intervention

Participants in the control group will watch a video instructing them on postoperative care. Participants in the control group will receive a handout on postoperative care with a QR code to the video.

Who Is Running the Clinical Trial?

George Washington University

Lead Sponsor

Trials

263

Recruited

476,000+

Findings from Research

A study involving 48 patients with distal radius fractures showed that those who followed an independent home exercise program had significantly better wrist functionality after 6 weeks compared to those receiving physical therapy, achieving 54% grip strength and 79% range of motion compared to their uninjured wrist.

The home exercise group also reported nearly 50% lower scores on the Patient Related Wrist Evaluation (PRWE), indicating better overall wrist function, suggesting that home-based rehabilitation can be an effective alternative to traditional physical therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physiotherapy after volar plating of wrist fractures is effective using a home exercise program. Krischak, GD., Krasteva, A., Schneider, F., et al.[2022]

In a study of 100 patients recovering from hand, wrist, shoulder, foot, or ankle fractures, those involved in litigation required significantly more help with daily activities, averaging over 3 hours more assistance per day compared to non-litigants (6.4 hours vs. 2.75 hours).

The need for help with activities such as dressing, shopping, and cooking was strongly influenced by whether patients were claiming compensation for their injuries, with a significant correlation found (p<0.0001), while complications from fractures did not affect litigation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extra help required by litigants after simple fractures--a questionnaire based study. Atkinson, JJ., Woods, MJ., Lovell, ME.[2015]

In a study of 204 hip-fracture patients undergoing rehabilitation, improvements were observed in all activities of daily living (ADLs), with walking showing the highest efficiency and effectiveness post-rehabilitation.

Key determinants of functional outcomes included basic ADLs such as eating, bathing, and bladder control, suggesting that assessing these activities can help predict recovery and guide treatment for hip fracture patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determinants of outcome in hip fracture: role of daily living activities. Gialanella, B., Ferlucci, C., Monguzzi, V., et al.[2015]

The ADOC-H decision-aid effectively encouraged 8 patients with distal radius fractures to engage in 158 activities using their injured hand, leading to improvements in wrist motion, grip strength, and overall arm function.

Occupational therapists found the ADOC-H to be a valuable tool for promoting real-life use of the injured hand, particularly for patients hesitant to use their hand due to fear of pain or injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinical utility of a decision-aid to facilitate the use of the hand in real-life activities of patients with distal radius fractures: A case study. Ohno, K., Saito, K., Matsumoto, H., et al.[2021]

In a study of 24 patients who underwent hand and wrist fracture surgery, postoperative physician phone calls did not lead to improved patient compliance with treatment recommendations or better clinical outcomes, as measured by the Brief Michigan Hand Questionnaire and satisfaction ratings.

Despite the lack of improvement from phone calls, the study found that a significant number of patients (67%) did not follow up as recommended, and 33% experienced complications, highlighting ongoing challenges in patient adherence to postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Postoperative Physician Phone Calls for Hand and Wrist Fractures: A Prospective, Randomized Controlled Trial. Loewenstein, SN., Pittelkow, E., Kukushliev, VV., et al.[2022]

Early motion is an important strategy in treating hand and wrist fractures, as it can help improve recovery and function.

The decision to use early motion should be based on a careful assessment of the benefits versus the risks for each individual patient, ensuring personalized treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early motion in the treatment of fractures and dislocations in the hand and wrist. Margles, SW.[2016]

In a study involving 300 participants aged 60 and older, there was no significant difference in wrist pain or function at 12 months between those treated surgically with a volar-locking plate and those treated nonsurgically with a cast.

Although patient-reported treatment success was higher in the surgical group, the overall outcomes for pain and quality of life were similar, suggesting that surgical intervention may not provide substantial benefits over nonsurgical treatment for this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical Plating vs Closed Reduction for Fractures in the Distal Radius in Older Patients: A Randomized Clinical Trial. Lawson, A., Naylor, JM., Buchbinder, R., et al.[2022]

Wrist arthrodesis is recommended for distal radial fractures with severe bone loss, as it effectively restores alignment and stability, controls pain, and promotes early functional recovery.

The procedure can reduce treatment costs and complications by allowing for simultaneous carpectomy or using local bone grafts, making it beneficial even in cases of polytrauma or multiple fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early wrist arthrodesis for irreparable intra-articular distal radial fractures. Freeland, AE., Sud, V., Jemison, DM.[2019]

The Dutch version of the DASH questionnaire has been validated for use in assessing pain and disability in patients with hand and wrist injuries, based on a study of 370 patients.

The findings suggest that the DASH should be treated as a unidimensional measure, meaning a single overall score is sufficient for evaluating patient outcomes rather than relying on subscale scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Structural validity of the Dutch version of the disability of arm, shoulder and hand questionnaire (DASH-DLV) in adult patients with hand and wrist injuries. van Eck, ME., Lameijer, CM., El Moumni, M.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Physiotherapy after volar plating of wrist fractures is effective using a home exercise program. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Extra help required by litigants after simple fractures--a questionnaire based study. [2015]

3. Italy pubmed.ncbi.nlm.nih.gov

Determinants of outcome in hip fracture: role of daily living activities. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

The clinical utility of a decision-aid to facilitate the use of the hand in real-life activities of patients with distal radius fractures: A case study. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

The Effects of Postoperative Physician Phone Calls for Hand and Wrist Fractures: A Prospective, Randomized Controlled Trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Early motion in the treatment of fractures and dislocations in the hand and wrist. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Surgical Plating vs Closed Reduction for Fractures in the Distal Radius in Older Patients: A Randomized Clinical Trial. [2022]

8. Singapore pubmed.ncbi.nlm.nih.gov

Early wrist arthrodesis for irreparable intra-articular distal radial fractures. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Structural validity of the Dutch version of the disability of arm, shoulder and hand questionnaire (DASH-DLV) in adult patients with hand and wrist injuries. [2019]