64 Participants Needed

Relative Motion Orthosis for Finger Stiffness

NR
Overseen ByNatalia Ruiz, DPT
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: NYU Langone Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this feasibility pilot study is to determine the effectiveness of Relative Motion Orthosis (RMO) in regaining finger range of motion compared to standard care in patients diagnosed with Proximal Interphalangeal (PIP) stiffness with an extension lag secondary to finger injury. Participants will be enrolled and randomized into groups receiving either standard conservative interventions or standard interventions in addition to the RMO. The primary endpoint is to evaluate the efficacy of relative motion orthosis in PIP ROM using clinical scoring and physical exam findings.

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.

How does the Relative Motion Orthosis treatment differ from other treatments for finger stiffness?

The Relative Motion Orthosis is unique because it allows for controlled movement of the fingers, which can help with positioning, protection, and exercise after tendon repairs. Unlike other treatments, it can be customized to the individual's needs and the specific amount of motion required, making it a versatile option for hand rehabilitation.12345

What data supports the effectiveness of the treatment Relative Motion Orthosis for finger stiffness?

Research shows that using orthoses, like the Relative Motion Orthosis, can increase the range of motion in stiff fingers by an average of 25.8%, although results can vary based on factors like age and the severity of stiffness.12346

Who Is on the Research Team?

NR

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 in my finger joint that limits its straightening.
I have an injury to my right or left hand.
See 2 more

Exclusion Criteria

I have severe joint pain or disease.
I have no hand injuries that would stop me from using a hand support device.
Literacy deficits: patients need to be able to follow verbal and written instructions independently to minimize risks and improve outcomes from care.
See 1 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Orthosis + standard hand therapy careExperimental Treatment2 Interventions
Group II: Standard of careActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

Citations

Relative motion orthoses for early active motion after finger extensor and flexor tendon repairs: A systematic review. [2023]
Photovoice to explore the patient experience of a relative motion orthosis following a hand injury. [2023]
Relative motion orthoses: fabrication tips. [2023]
Relative motion orthoses: A five-question decision making tool for thinking beyond thermoplastics. [2023]
[Role of orthosis in the treatment of stiffness of the hand]. [2006]
The Use of Relative Motion Flexion Orthoses for Chronic Boutonniere Deformity. [2022]
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