Pilot Study on The Effectiveness of Relative Motion Orthosis in Finger Motion

NYU Langone Health

Status: Enrolling

Conditions: Proximal Interphalangeal Joint Stiffness

Treatments: Device: RMO flexion orthosis (splint); Other: Standard of care

Study type: Interventional

Funder types: Other

Identifiers

NCT06646029

23-00609

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age range 18-80
• Any gender
• Any Proximal Interphalangeal (PIP) injury that causes reduced PIP Active Range of Motion (AROM) in extension
• Right or left hand injury
• Level of Chronicity (4 weeks - 6 months)
• Able to follow instructions

Exclusion criteria

• PIP with hard end feel (feels they need serial casting) - level of chronicity
• Any digital nerve injury / skin laceration that can prevent the patient from using the orthosis
• Severe arthropathy
• Literacy deficits: patients need to be able to follow verbal and written instructions independently to minimize risks and improve outcomes from care.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Orthosis + standard hand therapy care

Experimental group

Description:

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.

Treatment:

Other: Standard of care

Device: RMO flexion orthosis (splint)

Standard of care

Active Comparator group

Description:

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.

Treatment:

Other: Standard of care