NCT05425433

Brief Summary

The use of a splint, serial casting and passive stretching have been described in the literature as conservative interventions to manage joint contractures after burn injury. There is a paucity of literature investigating the effect of serial casting on scar contractures following upper extremity (UE) burn injury in adults and a lack of studies using strong methodological approaches. There are also no studies investigating the effect of casting on hypertrophic scars (HSc) and on self-reported UE function. This study is a longitudinal case series design with a criteria for change on the use of serial casting for the treatment of upper extremity burn contractures. The purpose of this study is to estimate the extent to which range of motion (AROM and PROM), scar characteristics and patient-reported upper-extremity function changes following an individually-tailored serial casting treatment program after switching from one week of usual care and to determine if these changes can be maintained 3 weeks after stopping serial casting, for adult burn survivors who developed an upper-extremity joint contracture greater than 15% normal range of motion within 1-year post-burn. This study will be a longitudinal case series design with a criteria for change. A minimum of 12 participants will be recruited from the "Centre d'expertise pour les victimes de brûlures graves de l'ouest du Québec" (CEVBGOQ) and will undergo one week of "usual care". If the PROM of the joint does not improve after one week of usual care, the participant will start the serial casting process, which will be prescribed by the treating OT. PROM/AROM and scar characteristics will be measured using a revised goniometry protocol that incorporates cutaneokinematics (CKM) principles and precise skin measures (DermaScan C, Cutometer®, Mexameter® and Tewameter®) at baseline, every Monday and Friday of the treatment weeks and 3 weeks after treatment cessation. Self-reported UE function and satisfaction related to scarring will be assessed at baseline and 3 weeks after treatment cessation using the QuickDASH and the patient satisfaction assessment scale (PSAS). Analysis on ROM and scar characteristic will be conducted using a graphical representation with a projected "usual care" regression line to count how many outcomes were over the line once the treatment was introduced. This study will contribute to building evidence for the use of serial casting following UE burn contractures in the adult population.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

September 20, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2025

Completed
Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

2.9 years

First QC Date

June 14, 2022

Last Update Submit

March 18, 2026

Conditions

Keywords

Burns, Burn Rehabilitation, Serial Casting

Outcome Measures

Primary Outcomes (2)

  • Passive range of motion changes

    PROM measures by goniometer (standard and revised goniometry protocol)

    Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention

  • Active range of motion changes

    AROM measures by goniometer (standard and revised goniometry protocol)

    Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention

Secondary Outcomes (7)

  • Patient reported upper-extremity function changes

    Baseline, 3 weeks post intervention

  • Scar patient satisfaction

    Baseline, 3 weeks post intervention

  • Skin Thickness Changes

    Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention

  • Skin Elasticity Changes

    Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention

  • Skin Erythema Changes

    Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention

  • +2 more secondary outcomes

Study Arms (1)

Serial casted joint

EXPERIMENTAL

Tailored serial casting intervention following 1 week of usual care

Other: Tailored serial casting intercention

Interventions

Every participant will undergo 1 week of usual care for the affected joint according to the OT's prescription (static progressive, dynamic or serial static) combined with stretching, moisturizers, pressure therapy, or thermal modalities. After the one week of splinting, if the PROM of the targeted joint does not improve, the participant will start serial casting (Monday to Friday). Patients will have a cast applied on Monday morning and worn for 24hrs/day or for 48hrs according to the OTs and treating physician's decision (rationale documented).The OT will decide how many weeks the participant will be wearing casts and the rationale to stop this treatment will be documented. When the treatment is stopped, patients will be encouraged to wear a maintenance splint for the following 2 weeks.

Serial casted joint

Eligibility Criteria

Age16 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Burn survivors with \>15% loss of PROM of their PIP, MCP, wrist, or elbow in either: flexion, extension, ulnar deviation or radial deviation.
  • Fire, flame or scald burn injury
  • ≥16 years old
  • have provided informed consent.

You may not qualify if:

  • Frostbite, chemical or electrical burn injury
  • A premorbid musculoskeletal or neurological disorder that limited their ROM
  • Have sustained a neurological injury secondary to the burn injury
  • A psychiatric or cognitive disorder that limits their ability to follow the research protocol
  • Have been diagnosed with heterotopic ossification
  • PROM is contraindicated for any reason
  • Do not understand English or French.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital de réadaptation Villa Médica

Montreal, Quebec, H2X 1C9, Canada

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Bernadette Nedelec, PhD

    CRCHUM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2022

First Posted

June 21, 2022

Study Start

September 20, 2022

Primary Completion

August 31, 2025

Study Completion

September 20, 2025

Last Updated

March 20, 2026

Record last verified: 2026-03

Locations