Early ADL Participation for Wrist Fracture Recovery

Overseen By Sarah Doerrer, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: George Washington University

Disqualifiers: Neurological conditions, Cognitive deficits, Psychological deficits, Multiple injuries, Others

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

Compensation: Varies

Number of Visits: 6

64 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how engaging in daily activities early can aid recovery after a wrist fracture treated with a cast. Participants are divided into two groups: one receives guidance on using their injured hand for daily tasks (ADL/Cast Care instruction), while the other receives standard advice on cast care. Researchers will compare results from both groups at various intervals to determine if early activity accelerates recovery. This trial may suit individuals who have had a wrist fracture within the last three weeks and are managing it with a cast. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, providing an opportunity to contribute to foundational knowledge in recovery methods.

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 prior data suggests that this protocol is safe for wrist fracture recovery?

Research has shown that starting daily activities soon after a wrist fracture is usually safe. For instance, studies have found that light activities, such as squeezing a towel or performing gentle gripping exercises, can begin just two weeks after the injury. These activities are safe and help improve hand function in the short term.

While specific data on negative effects from starting daily activities early is lacking, the emphasis on low-effort exercises suggests that care is taken to avoid harm. This approach aims to gradually strengthen the wrist without causing additional pain or injury.

Overall, beginning daily activities early appears to be a safe part of recovery for those with wrist fractures, provided it is done carefully and gradually. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how early engagement in activities of daily living (ADL) can aid wrist fracture recovery. Unlike traditional methods that focus primarily on immobilization and later rehabilitation, this approach emphasizes early functional participation. By providing patients with a comprehensive ADL and cast care instructional video and handout, the trial aims to promote quicker recovery and greater independence. This proactive strategy could potentially reshape how we approach fracture recovery, offering patients a more active role in their healing process.

What evidence suggests that early ADL participation is effective for wrist fracture recovery?

Research has shown that using your hand in everyday activities soon after a wrist fracture can aid recovery. One study found that engaging in daily tasks early can reduce the risk of complications and enhance healing. Another study found that using your hand for daily activities can improve wrist movement, strengthen grip, and enhance hand skills, while also reducing pain and swelling. In this trial, participants will receive either ADL/Cast Care instruction or Cast Care Instruction. These findings suggest that learning to safely use your injured hand while it's in a cast can significantly improve healing and hand function. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

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 am over 18 years old.

Less than 3 weeks from DRF

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

Citations

1.

withpower.com

withpower.com/trial/early-phase-1-radius-fractures-1-2023-b9017

Early ADL Participation for Wrist Fracture Recovery

The available research shows that Early ADL Participation for Wrist Fracture Recovery can be effective in reducing complications and improving patient ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8977782/

Effectiveness and cost-effectiveness of surgery versus ...

This study aims to assess non-inferiority of functional outcomes after casting versus surgery in elderly patients with a non-acceptable position following a ...

3.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2781183

Comparison of 24-Month Outcomes After Treatment for ...

This randomized clinical trial compares 24-month outcomes among older adults with distal radius fractures across 4 treatment groups: volar ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9250132/

Rehabilitation for distal radial fractures in adults - PMC

This usually involves the reduction of the fracture if displaced, and forearm immobilisation in a plaster cast or brace for around six weeks.

5.

researchgate.net

researchgate.net/publication/304344971_Early_occupational_performance_intervention_enhances_outcome_after_distal_radius_fracture_A_nonrandomized_controlled_trial

Early occupational performance intervention enhances ...

DRF often causes reduced range of wrist motion (wrist ROM), loss of grip strength and dexterity as well as pain and edema of the injured hand, ...

6.

jospt.org

jospt.org/doi/10.2519/jospt.2024.0301

Distal Radius Fracture Rehabilitation

Clinicians should initiate submaximal progressive strengthening, such as towel and putty squeezing and light-load gripping exercises at 2 weeks ...

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S0894113022001119

Managing patient expectations about recovery after a distal ...

The study aimed to determine the general course of patient-reported functional recovery and complaints during 1 year after a DRF, depending on fracture type ...