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Do relative motion flexion orthoses improve proximal interphalangeal joint extension following traumatic finger injury or surgery? A randomised controlled trial

Do relative motion flexion orthoses improve proximal interphalangeal joint extension in adults following traumatic finger injury or surgery? A randomised controlled trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000897561
Enrollment
56
Registered
2024-07-23
Start date
2024-08-01
Completion date
2026-08-01
Last updated
2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This project aims to evaluate the role of the relative motion flexion orthosis in recovery of proximal interphalangeal joint (PIPJ) extension following hand injury or surgery. Participants who have 20 degrees or more PIPJ extension deficit, and satisfy the other inclusion criteria, will be eligible to participate. They will be randomised into two groups; usual care, or usual care with the addition of the relative motion orthosis. Assessments will be completed at baseline and six weeks post commencement of intervention. We hypothesise that the intervention group will have greater PIPJ extension at six weeks, compared to the control group.

Interventions

The intervention group will receive the relative motion flexion orthosis, in addition to usual care (see below for details about control group). The orthosis will be fabricated using TailorSplint thermoplastic material, and positioned with the affected finger metacarpophalangeal joint (MCPJ) in approximately 20 degrees of relative flexion, compared to adjacent fingers MCPJs. It will include three or four fingers in the design, as per hand therapist and patient decision to maximise adherence.

The intervention group will receive the relative motion flexion orthosis, in addition to usual care (see below for details about control group). The orthosis will be fabricated using TailorSplint thermoplastic material, and positioned with the affected finger metacarpophalangeal joint (MCPJ) in approximately 20 degrees of relative flexion, compared to adjacent fingers MCPJs. It will include three or four fingers in the design, as per hand therapist and patient decision to maximise adherence. The orthosis will be fabricated during the 60-minute face-to-face consultation with the hand therapist at baseline. At least one face-to-face follow-up appointment will be scheduled within 1-2 weeks of orthosis provision to review the comfort of the orthosis and answer any questions about the therapy treatment. Therapists may choose to rebook the participant for additional sessions as they deem appropriate during the six-week study period, as per their discretion and clinical reasoning. Participants will be guided by their therapist to wear the orthosis a minimum of four hours per day, during functional hand use and exercises. Adherence to the orthotic intervention will be recorded weekly using a paper patient diary, noting average orthotic wear-time and activities the orthosis was removed for.

Sponsors

Macquarie University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Participants will be eligible to participate in the trial if they: - 18 years and over - attending hand therapy following traumatic finger injury or surgery resulting in a >/= 20° active proximal interaphalangeal joint (PIPJ) extension deficit - multi-digit injury (two or three injured fingers, with the finger with the greatest PIPJ deficit included) - PIPJ movement restrictions resulting from hand injury not directly affecting the PIPJ but causing secondary stiffness due to immobilization. - treating therapist deems it is clinically appropriate given the nature and stage of injury - are able to provide written informed consent prior to enrolment in the study.

Exclusion criteria

Participants will be excluded if they are attending therapy for: - injury to all four fingers (as the relative motion orthosis cannot be used) - Dupuytren’s contracture or post-contracture release surgery - burns - amputation - trigger finger - neurological condition as the primary cause of PIPJ movement restrictions - inflammatory conditions as the primary cause of PIPJ movement restrictions - previous injury to the same finger resulting in movement restrictions They will also be excluded if the below apply: - previous relative motion orthotic intervention for the current injury - those unable to provide informed consent in English - do not agree to follow up for treatment at a clinic participating in the trial.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026