Relative Motion Orthosis for Finger Stiffness

Overseen By Natalia Ruiz, DPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Digital nerve injury, Severe arthropathy, others

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

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

64 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special finger brace, the Relative Motion Orthosis (RMO), can improve finger movement recovery after an injury more effectively than standard care alone. Participants will be divided into two groups: one using the RMO with regular hand therapy, and the other receiving only standard therapy. The trial seeks individuals with finger injuries causing stiffness and difficulty straightening their fingers for 4 weeks to 6 months. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for finger injuries.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Relative Motion Orthosis is safe for treating finger stiffness?

Research shows that Relative Motion Orthoses (RMO) are generally safe for aiding finger healing after an injury. Studies have found that these devices help people regain finger movement following tendon repairs. Importantly, these studies have reported no major safety issues. While some individuals might experience minor discomfort or skin irritation, this is uncommon. Overall, RMOs are well-tolerated and offer a promising method to enhance finger movement after an injury. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Relative Motion Orthosis because it offers a unique approach to treating finger stiffness. Unlike standard hand therapy, which relies on physical exercises and manual techniques, this treatment involves wearing a custom-made splint during the day. The orthosis is designed to help improve finger flexibility by allowing certain motions while restricting others, potentially enhancing the effectiveness of traditional therapy. By integrating this innovative orthosis with standard care, there is hope for faster and more significant improvements in finger mobility.

What evidence suggests that the Relative Motion Orthosis is effective for finger stiffness?

Research has shown that relative motion orthoses (RMO) can improve finger movement. In this trial, one group of participants will receive an RMO alongside standard hand therapy care. Studies have found that these devices enable people to regain function sooner, especially after tendon repairs. RMOs are safe and support active finger movement during recovery. Typically worn during daily activities and exercise, they help enhance hand function. Early evidence suggests that RMOs may lead to a faster recovery compared to other methods. ^{1 2 3 4 6}

Who Is on the Research Team?

Natalia Ruiz, DPT

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for individuals with finger stiffness, specifically Proximal Interphalangeal (PIP) joint extension lag due to injury. Participants will be randomly assigned to receive either standard care or standard care plus a Relative Motion Orthosis (RMO) flexion splint.

Inclusion Criteria

My gender does not affect my eligibility.

I have an injury to my right or left hand.

I have an injury in my finger joint that limits its straightening.

Exclusion Criteria

Literacy deficits: patients need to be able to follow verbal and written instructions independently to minimize risks and improve outcomes from care.

I have severe joint pain or disease.

I have no hand injuries that would stop me from using a hand support device.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either standard conservative interventions or standard interventions in addition to the Relative Motion Orthosis (RMO) for 6 weeks

6 weeks

Participants are encouraged to use the orthosis during the day (at least 6-8 hours)

Follow-up

Participants are monitored for changes in QuickDASH score and Active Range of Motion (AROM) after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Relative Motion Orthosis

Trial Overview The study aims to compare the effectiveness of using an RMO flexion orthosis against standard treatment alone in improving finger movement. Success will be measured by how much range of motion in the PIP joint is regained.

How Is the Trial Designed?

Group I: Orthosis + standard hand therapy care Experimental Treatment 2 Interventions

Patients will receive a custom splint/orthosis will be made by the hand therapist for patients to wear through the day for the length of the treatment as much as possible in additional to standard of care hand therapy. Patients will be encouraged use the orthosis during the day (at least 6-8 hours) for 6 weeks.

Group II: Standard of care Active Control 1 Intervention

Standard of care (control group) will only complete the routine treatment. This consists of physical therapy exercises, stretches, manual therapy and use of therapeutic modalities.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06985459

Effectiveness of Exercise Relative Motion Orthoses for ... This randomized controlled trial investigates the effectiveness of two exercise orthosis designs-the Relative Motion Flexion (RMF) and Relative Motion ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11856411/

Evaluation of Hand Function Using Relative Motion ... This study aimed to compare outcomes of early active motion (EAM) using the relative motion extension (RME) approach to outcomes of early passive motion ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0894113023000121

Are the outcomes of relative motion extension orthoses non ... Relative motion orthoses have been shown to be a safe method of rehabilitation, reported to allow early return to function following extensor tendon repair,6,30 ...

4. asht.org asht.org/sites/asht/files/images/International/Nov%202022/Relative%20Motion%20Orthoses%20in%20the%20Management%20of%20Various%20Hand%20Conditions-A%20Scoping%20Review.pdf

Relative Motion Orthoses in the Management of Various ... In some studies, data were pooled across conditions and different orthosis types, limiting our ability to report outcomes. Many studies lacked ...

5. jhandtherapy.org jhandtherapy.org/article/S0894-1130(22)00117-X/abstract

The use of exercise relative motion orthoses to improve ... Exercise RM orthoses were prescribed weekly to monthly (82%) for between 2-6 weeks duration (81%) and used during exercise and function (87%).

6. jhandtherapy.org jhandtherapy.org/article/S0894-1130(23)00013-3/abstract

Relative motion orthoses for early active motion after finger ... There is now good evidence that the RM approach is safe in zones V-VI extensor tendon repairs. Limited evidence currently exists for zones IV ...