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Advances in Hand Therapy: Best practice in conservative management of proximal phalangeal fractures in children.

Advances in Hand Therapy: Reducing splinting time in conservative management of proximal phalangeal fractures in children that have been been assessed as being clinically healed.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619001714178
Enrollment
80
Registered
2019-12-05
Start date
2018-08-10
Completion date
2021-06-17
Last updated
2022-04-19

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

Conditions

None listed

Brief summary

The most common traumatic hand injury we see at CHW in hand therapy is a fracture of the proximal phalanx bone of the finger and thumb. Current practice involves 5 weeks of thermoplastic splinting with a minimum of 3 face to face outpatient appointments. We would like to investigate the effect of reducing splinting time for children aged 5-16 years, who present as clinically healed at 3 weeks post proximal phalanx fracture. This study aims to determine whether we can reduce overall treatment time for children who have sustained a proximal phalanx fracture. Participants will be recruited at their 3 week follow-up appointment. All participants will be assessed by a senior hand therapist for fracture healing. Those that are clinically assessed as being healed at 3 weeks will be included in the trial. The first group will follow our current protocol and remain splinted part-time for a further 2 weeks. The second group will follow a new protocol and will cease splinting. All participants will be followed up at 5 weeks post injury, as is current practice. At 5 weeks, assessment will include grip strength, range of motion and a patient reported questionnaire. The only additional time commitment will be a follow up phone call at 8 weeks post injury which may take 5 minutes of the parent or guardians time to re administer the PRQ. Safety will be ensured through interventions being provided by a senior hand therapist, education, written handouts and regular follow-up.

Interventions

Intervention: Splinting (group 1) vs no splinting (group 2) of proximal phalangeal fractures that have been clinically assessed as being healed at 3 weeks post injury. All face to face interventions will be delivered at The Children's Hospital at Westmead outpatient department. Visit 1, 30 minutes (within 2 weeks post fracture) - Study information will be provided to potential participants. - Fabrication of a thermoplastic splint and instructions given about full-time wearing regime and prec

Intervention: Splinting (group 1) vs no splinting (group 2) of proximal phalangeal fractures that have been clinically assessed as being healed at 3 weeks post injury. All face to face interventions will be delivered at The Children's Hospital at Westmead outpatient department. Visit 1, 30 minutes (within 2 weeks post fracture) - Study information will be provided to potential participants. - Fabrication of a thermoplastic splint and instructions given about full-time wearing regime and precautions. Visit 2, 30 minutes (range 3 weeks to 4 weeks post immobilisation) - Administration staff to obtain consent. - Eligibility for stage 2 inclusion will be assessed by a senior hand therapist - For those eligible envelope randomization will be used to determine study group - All participants will have total active motion (TAM) measures recorded of their affected digit/s and the contralateral digit/s on the unaffected hand. TAM will be measured using a rolyan goniometer. - Participants randomly allocated to Group 1 standard treatment will commence AROM exercises three times per day. Those with finger injuries will commence tendon gliding exercises x 10 repetitions and finger lifts x 10 repetitions. Those with thumb injuries will commence thumb finger touch x 10 repetitions and slides x 10 repetitions. Participants will be instructed to remove their splints for exercises and light functional use at home only. Splints must be worn overnight, for school and for high risk activities. - Participants allocated to the Group 2 new protocol group will commence the same exercises as those who receive standard treatment, as outlined above. Participants will be instructed to cease splinting from this appointment. They are able to resume light activities and will be advised not to participate in sports or high risk activities. Therapists will advise the participant to buddy tape the affected finger to the adjacent finger if there is concern about the participant’s ability to follow safety instructions. - Participants will then be booked in with a different senior hand therapist/investigator for their 5 week follow up appointment which will ensure blinding of therapists. Visit 3, 30 minutes (5 weeks to 6 weeks post immobilisation) - Participants will attend their scheduled appointment and check in with reception staff. For participants in group 1 who are wearing splints reception staff will ask them to take their splint off to ensure investigators are blinded to their group allocation. - Participants will have TAM measures recorded of their affected digit/s and the contralateral digit/s on the unaffected hand. TAM will be measured using a rolyan goniometer. - Participants will have grip strength measured, and those with thumb fractures will also have lateral pinch strength measured using a citec dynamometer. Participants will be instructed to hold their elbow by their side and at approximately 90 degrees of flexion. The investigator will give verbal instructions and modeling will be used to assist with position. 3 measures will be taken for the unaffected hand and then the affected hand and an average for each hand will be calculated and recorded. - The patient rated questionnaire PRQ will be administered during the session with questions being asked verbally by the therapist and yes/no responses being recorded. - Average grip strength, TAM measures and PRQ scores will be entered into an excel spreadsheet. - The therapist can then be unblinded and review EMR notes if required. - Commence light strengthening for all participants in both group - Parents/guardians will be given a choice for follow-up contact at 8 weeks post injury – either email, text or phone call. Week 8, 5 minutes - PRQ can be texted, emailed or a phone call will be made. Four attempts will be made to contact participants. Did not attend appointment - Reception staff will contact and determine why they did not attend. Attempts will be made to book them in ASAP in order to capture all participants at the appropriate time.

Sponsors

The Children's Hospital at Westmead
Lead SponsorHospital

Study design

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

Eligibility

Sex/Gender
All
Age
5 Years to 16 Years
Healthy volunteers
No

Inclusion criteria

INCLUSION CRITERIA Stage 1: • Children aged between 5 to 16 years Confirmed proximal phalanx fracture which is undisplaced or minimally displaced and stable that is being conservatively managed including closed reduction (performed in ED or in outpatient clinic (not in theatre) • Unaffected contralateral hand • Early diagnosis (within 2 weeks post fracture) Stage 2: • Assessed as being clinically healed at visit 2 by senior hand therapist

Exclusion criteria

EXCLUSION CRITERIA • Late presentation (3 weeks post fracture to initial review). Late presentation means the fracture will take longer to heal. • Behavioral or communication issues which may affect assessment • Surgical intervention including closed reduction in theatre • Unable to attend future appointments • Non- compliance with splinting within the first 3 weeks, as they will not be able to comply with the study protocol.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026