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RECRUITING
NCT06985459
NA

Effectiveness of Exercise Relative Motion Orthoses for Limited Finger Joint Motion

Sponsor: Insel Gruppe AG, University Hospital Bern

View on ClinicalTrials.gov

Summary

This randomized controlled trial investigates the effectiveness of two exercise orthosis designs-the Relative Motion Flexion (RMF) and Relative Motion Extension (RME) orthoses-for improving motion in patients with proximal interphalangeal joint (PIPJ) flexion or extension deficits. A total of 148 adult patients with acute hand injuries and a minimum 10° difference between active and passive PIP joint motion will be enrolled. Participants are stratified by their primary motion deficit and randomized to either the exercise orthosis or placebo orthosis group. The orthosis is worn for 4 weeks, with follow-up assessments at weeks 6 and 8 to evaluate range of motion and patient satisfaction. All participants will continue standard hand therapy throughout the study.

Official title: Effectiveness of Exercise Relative Motion Orthoses for Improving Limited Proximal Phalangeal Joint Motion: A Single-Center, Single-Blinded Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

148

Start Date

2025-05

Completion Date

2028-05

Last Updated

2025-05-29

Healthy Volunteers

No

Interventions

DEVICE

PIP extension deficit treated with an exercise RMF orthosis

The RM orthoses will be worn between 6-12 hours per day during functional use.

DEVICE

PIP extension deficit treated with a placebo RMF orthosis

The placebo orthosis has the same design as the exercise RM orthoses, but without a difference in the extension or flexion angle, respectively, to the adjacent finger - therefore neutralizing the "quadriga phenomena", which is the effect that makes RM orthoses work.

DEVICE

PIP flexion deficits treated with a placebo RMF orthosis

The placebo orthosis have the same design as the exercise RM orthoses, but without a difference in the extension or flexion angle, respectively, to the adjacent finger - therefore neutralizing the "quadriga phenomena", which is the effect that makes RM orthoses work.

DEVICE

PIP flexion deficits treated with an exercise RME orthosis

The dedicated orthosis wearing time is 6-12 hours per day during functional use.

Locations (1)

University Hospital Bern

Bern, Canton of Bern, Switzerland