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

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 6}

Research Team

Natalia Ruiz, DPT

Principal Investigator

NYU Langone Health

Eligibility Criteria

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.

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.

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

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

Relative motion orthoses for early active motion after finger extensor and flexor tendon repairs: A systematic review. [2023]

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

Photovoice to explore the patient experience of a relative motion orthosis following a hand injury. [2023]

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

Relative motion orthoses: fabrication tips. [2023]

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

Relative motion orthoses: A five-question decision making tool for thinking beyond thermoplastics. [2023]

5. France pubmed.ncbi.nlm.nih.gov

[Role of orthosis in the treatment of stiffness of the hand]. [2006]

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

The Use of Relative Motion Flexion Orthoses for Chronic Boutonniere Deformity. [2022]