Early ADL Participation for Wrist Fracture Recovery

Overseen By Sarah Doerrer, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: George Washington University

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

Compensation: Varies

Number of Visits: 6

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 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.

Do I have to stop taking my current medications for the trial?

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

What data supports the idea that Early ADL Participation for Wrist Fracture Recovery is an effective treatment?

The available research shows that Early ADL Participation for Wrist Fracture Recovery can be effective in reducing complications and improving patient satisfaction. For example, a study on cast care education found that providing continuous access to specific instructions decreased cast complications in pediatric patients. Additionally, a quality improvement initiative in a pediatric hospital reduced the need for changing casts by over 50%, which also lowered healthcare costs. These findings suggest that educating patients and involving them early in their recovery can lead to better outcomes compared to standard care. ^{1 2 3 4 5}

What safety data exists for early ADL participation in wrist fracture recovery?

The provided research does not contain specific safety data for early ADL participation or related treatments for wrist fracture recovery. The studies focus on adverse drug reactions in various healthcare settings, which are not directly related to the safety of early ADL participation or cast care education for wrist fractures. ^{6 7 8 9 10}

Is the treatment ADL/Cast Care instruction promising for wrist fracture recovery?

Yes, the treatment ADL/Cast Care instruction is promising for wrist fracture recovery. It focuses on helping patients use their injured hand in real-life activities, which can improve their ability to perform daily tasks and enhance their physical recovery. ^{2 11 12 13 14}

Eligibility Criteria

This trial is for English-speaking adults over 18 who have a distal radius fracture (DRF) treated with a cast and are less than 3 weeks from injury. It excludes those with neurological, cognitive, or psychological issues affecting the upper limb, multiple injuries to one or both upper limbs, prior DRFs on the same wrist, surgery for DRF fixation, or ongoing hand therapy for another injury.

Inclusion Criteria

I speak English.

I am over 18 years old.

My broken bone was treated with a cast.

Exclusion Criteria

Individuals with multiple injuries to the affected upper limb

I can accurately report my health status.

I have a condition that affects my arm or hand.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

0-3 weeks

1 visit (in-person)

Initial Evaluation and Intervention

Participants receive either the standard of care video and handout (control) or the intervention video and handout (experimental). Initial data collection occurs.

0-3 weeks

1 visit (in-person)

Treatment and Monitoring

Participants are monitored for function, pain, and fear of movement. Measurements of finger motion, grip, pinch strength, and fine motor coordination are taken.

3 months

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including any complications such as median nerve compression, tendonitis, or complex regional pain syndrome.

3 months

Treatment Details

Interventions

• ADL/Cast Care instruction
• Cast Care Instruction

Trial Overview The study compares two groups: one receives instructions on daily activities and cast care after a DRF via video and handout; the other only gets cast care information. Outcomes like wrist function, pain level, fear of movement, finger mobility, grip strength and fine motor skills will be measured at various intervals up to 3 months using specific tests.

Participant Groups

Group I: ADL video/Cast Care Experimental Treatment 2 Interventions

ADL/cast care instructional video ADL/cast care handout

Group II: Cast Care Video Active Control 1 Intervention

Cast care instructional video Cast care handout

Who Is Running the Clinical Trial?

George Washington University

Lead Sponsor

Trials

263

Recruited

476,000+

American Hand Therapy Foundation

Collaborator

Trials

2

Recruited

80+

Findings from Research

In a study involving 100 pediatric patients with upper extremity fractures, the customized 'Providence' Pedi Cast-Sling (PPCS) significantly improved patient and parent satisfaction compared to a standard sling, with higher convenience and compliance reported.

Patients using the PPCS wore the sling for an average of 10.3 hours a day, compared to only 5.9 hours for those with the standard sling, indicating that the PPCS encourages better adherence to immobilization after casting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and Parent Satisfaction With Sling Use After Pediatric Upper Extremity Fractures: A Randomized Controlled Trial of a Customized Cast-Sling Versus Standard Cast and Sling. Cruz, AI., DeFroda, SF., Gil, JA., et al.[2019]

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]

A quality improvement protocol in a pediatric hospital successfully reduced the transition rate from emergency department-applied casts to other forms of immobilization from 59.9% to 25.0%, achieving a 58% reduction.

The protocol not only improved patient care by shortening the average emergency department stay by about 26 minutes but also saved families nearly $130,000 annually in healthcare charges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A quality improvement initiative to reduce cast transitions in a pediatric hospital. Rowan, MR., Balch Samora, J.[2021]

A quality improvement project aimed at reducing cast complications in pediatric fractures involved providing patients with a QR code linked to a custom cast care website, which offered educational resources.

While the incidence of cast complications decreased by 7.6% over a 6-week period, this reduction was not statistically significant, suggesting that continuous access to tailored cast care instructions may help improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Patient and Parent Education in Pediatric Cast Complications. Kearney, L., Thompson, J., Zychowicz, M., et al.[2022]

Community pharmacists in Australia are willing to report adverse drug reactions (ADRs), but they face significant barriers related to their work environment and existing IT systems, which contribute to low reporting rates.

User testing of a web-based ADR reporting system showed above-average usability, but identified functional issues; improvements such as user-friendly design elements could enhance reporting and ultimately improve patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Linking Activity Theory Within User-Centered Design: Novel Framework to Inform Design and Evaluation of Adverse Drug Reaction Reporting Systems in Pharmacy. Fossouo Tagne, J., Yakob, RA., Mcdonald, R., et al.[2023]

In a study of 510 elderly patients (average age 80 years), the occurrence of adverse drug reactions (ADRs) was found to be 12.5%, with furosemide and digoxin being the most common culprits.

The study revealed that the frequency of ADRs was not correlated with the patients' age or the number of medications taken, suggesting that the type of drugs prescribed may be a more significant factor in causing ADRs in the elderly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Drug adverse effects in the elderly hospitalized with acute pathologies]. Beltrami, GC., Menegolli, GP., Corrà, L., et al.[2022]

In a study of 72 elderly residents (average age 80) from long-term care facilities, a high incidence of adverse drug reactions (ADRs) was found, with 26% of patients experiencing ADRs as defined by the WHO.

The study highlights that ADRs are a significant concern in this population, potentially contributing to their need for admission to acute geriatric wards, although the underlying reasons for this high incidence remain unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug reactions in long-term care facility residents. Budden, F.[2019]

In a study involving nursing home residents, it was found that residents reported significantly more potential adverse drug reactions (ADRs) than nurses, highlighting the importance of including resident feedback in monitoring medication safety.

The study revealed that over 90% of residents were on medications that could cause serious side effects, emphasizing the need for better communication between residents and healthcare providers to improve pharmacotherapeutic care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resident and nurse reports of potential adverse drug reactions. Dilles, T., Van Rompaey, B., Van Bogaert, P., et al.[2018]

The implementation of an adverse drug reaction (ADR) surveillance program in a 472-bed hospital led to a 13-fold increase in ADR reporting within the first year, highlighting its effectiveness in identifying drug reactions.

The program successfully detected a significant ADR related to an antibiotic, which resulted in changes to prescribing patterns, demonstrating its impact on patient safety and medication management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An adverse drug reaction reporting program in a community hospital. Tse, CS., Madura, AJ.[2019]

Distal radius fractures are common in Germany, and treatment decisions should carefully consider the stability of the fracture and the patient's overall health, with conservative treatment recommended for stable fractures or patients in poor condition.

Successful treatment involves precise reduction and stable immobilization in a plaster splint, with close monitoring through radiography to prevent secondary displacement, followed by a total immobilization period of 4 weeks and early physiotherapy starting at 2 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Conservative management of distal radius fractures]. Lucas, B., Lippisch, R., Pliske, G., et al.[2023]

In a study of 50 elderly patients with distal radius fractures, a 4-week cast immobilization period was found to be sufficient, showing no significant differences in pain, function, or bone healing compared to a 6-week period.

While the 6-week cast group had a greater mean volar tilt angle, both groups had similar outcomes in terms of union rate and other functional measures, suggesting that longer immobilization may not provide additional benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The functional and radiographic outcomes following distal radius fracture treatment in a cast for 4 and 6 weeks in the elderly: A randomized trial. Olech, J., Kopczyński, B., Tomczyk, Ł., et al.[2022]

Rehabilitation for distal radius fractures using an advice leaflet or video is as effective as face-to-face therapy, based on the DASH score measured six weeks post-intervention in a study of 116 participants.

The only significant difference found was that face-to-face therapy improved the DASH work subscale compared to the advice leaflet, suggesting that while all methods are effective, in-person therapy may offer some additional benefits for work-related activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of rehabilitation interventions in nonoperatively treated distal radius fractures: a randomized controlled trial of effectiveness. Coughlin, T., Norrish, AR., Scammell, BE., et al.[2021]

The study found that using the 'aid for decision-making in occupation choice for hand' (ADOC-H) combined with physical function-based interventions (PBI) significantly improved psychological outcomes, such as pain catastrophizing and anxiety, in patients with distal radius fractures (DRF) compared to PBI alone.

While both intervention groups showed similar physical function improvements, the ADOC-H approach was particularly effective in helping patients engage their injured hand in daily activities, highlighting its clinical utility in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Occupation-Based Intervention Using the ADOC-H Combined With Physical Function-Based Intervention on Patients With Distal Radius Fractures: A Retrospective Case-Control Study. Kukizaki, W., Ohno, K., Maruta, M., et al.[2023]

References

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

Patient and Parent Satisfaction With Sling Use After Pediatric Upper Extremity Fractures: A Randomized Controlled Trial of a Customized Cast-Sling Versus Standard Cast and Sling. [2019]

2. 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]

3. 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]

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

A quality improvement initiative to reduce cast transitions in a pediatric hospital. [2021]

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

The Role of Patient and Parent Education in Pediatric Cast Complications. [2022]

6. Canada pubmed.ncbi.nlm.nih.gov

Linking Activity Theory Within User-Centered Design: Novel Framework to Inform Design and Evaluation of Adverse Drug Reaction Reporting Systems in Pharmacy. [2023]

7. Italy pubmed.ncbi.nlm.nih.gov

[Drug adverse effects in the elderly hospitalized with acute pathologies]. [2022]

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

Adverse drug reactions in long-term care facility residents. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

Resident and nurse reports of potential adverse drug reactions. [2018]

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

An adverse drug reaction reporting program in a community hospital. [2019]

11. Germany pubmed.ncbi.nlm.nih.gov

[Conservative management of distal radius fractures]. [2023]

12. Poland pubmed.ncbi.nlm.nih.gov

The functional and radiographic outcomes following distal radius fracture treatment in a cast for 4 and 6 weeks in the elderly: A randomized trial. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Comparison of rehabilitation interventions in nonoperatively treated distal radius fractures: a randomized controlled trial of effectiveness. [2021]

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

Effect of Occupation-Based Intervention Using the ADOC-H Combined With Physical Function-Based Intervention on Patients With Distal Radius Fractures: A Retrospective Case-Control Study. [2023]