Clinical trial NCT02425267: Effectiveness of a Home Telerehabilitation Program for People With Proximal Humerus Fracture
Official title: Effectiveness of a Home Telerehabilitation Program for People With Proximal Humerus Fracture Treated Conservatively: a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Humeral Fractures, Proximal
Keywords: Telerehabilitation
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2015-04-23
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of the study is to compare the clinical effects of the innovative telerehabilitation approach (TELE group) compared to face-to-face visits to a clinic (CLINIC group) for patients treated for a proximal humerus fracture.

Detailed description: Every year, one out of three elderly people make at least one fall, and 10% of them cause a fracture. Of these fractures, those of the proximal humerus, the forearm and the wrist count for approximately one third of total osteoporotic fractures in elderly people. Proximal humerus fractures can be treated surgically (eg: pinning, plate and screws, etc..) or conventionally by wearing a splint or a cast. Whether either of these approaches, the individual requires rehabilitation to prevent function limitations.

Among the possible reasons for the low use of rehabilitation services, there are 1) poor availability of rehabilitation services for fractures of the humerus; or 2) the difficulty of the elderly to travel to receive these services because of their precarious status. Telerehabilitation is a promising alternative approach that can help improve access to rehabilitation services once patients are discharged from hospital.

Some studies demonstrate that physiotherapy is a significant factor in the process of healing and functional recovery of a proximal humerus fracture, and that, for conservative or surgical treatment. This is showed by the good recovery of patients and by their satisfaction with the physiotherapy. In addition, since the majority of patients with a proximal humerus fracture are elderly, it becomes relevant to find a new way to offer quick service physiotherapy and simple and suitable to their condition.

The main objective of the study is to compare the clinical effects of the innovative telerehabilitation approach (TELE group) compared to face-to-face visits to a clinic (CLINIC group) for patients treated for a proximal humerus fracture.

The research hypothesis are:

1. TELE intervention will be as effective as CLINIC intervention to improve upper extremity function.
2. TELE intervention will be as effective as CLINIC intervention to improve deficiencies of the shoulder (increase range of motion).
3. Participants who received the TELE intervention will be as satisfied of their care as participants who received the CLINICL intervention.
4. TELE intervention will be less costly compared to the CLINIC intervention.

Methodology: The study has a randomized control trial design. The study population of interest is individuals who have had proximal humerus fracture and who receive a conservative treatment at the Centre Hospitalier Universitaire de Sherbrooke (CHUS) and who are returning at home. Participants will be recruited during their visit at the emergency or outpatient clinic by the medical team or research nurse assistant. The investigators expect to recruit 52 participants, that is to say 26 per group. All evaluations will be completed in the research center/hospital and will be approximately 1.5 hour in duration. The first evaluation will be conducted when medical team will ask for rehabilitation (T1) to allow participant base measures to be collected. The other evaluation will be conducted immediately after the 2-month intervention (T2). The independent variable is conventional physiotherapy and experimental intervention by telerehabilitation. The dependant variables are 1) upper extremity function; 2) range of motion; 3) user satisfaction; 4) cost of services according to the healthcare system.

Platform used: In this study, a platform based on a technological infrastructure that was developed and tested in previous telerehabilitation studies will be used. The infrastructure combines a clinical information system with videoconference components (Tandberg 550 MXP, H 264) and uses cameras that are controlled by the clinician using computer software.

The difference between the two groups will then be compared using a t-test or a chi-square test. The economic analysis will be a type of cost-effectiveness. The cost per unit of change in the main dependent variable (Constant Score) will be determined for the two groups (TELE and CONTROL) and the cost differential will be established.

Eligibility criteria: Inclusion Criteria:

* Proximal humerus fracture (without surgery)
* Return home after discharge from hospital
* Be able to exercise;
* Have sufficient verbal and written understanding to participate to telerehabilitation sessions, and to be able complete the questionnaires;
* Have access to high-speed Internet at home.

Exclusion Criteria:

* Presence of intra-articular type proximal humerus fracture, which can lead to a greater risk of complication and may require a longer recovery time
* Fracture surgery as a treatment
* Presence of any other type of upper body fracture which can interfere with rehabilitation.

Primary outcomes:
measure: Shoulder function (score /100)
timeFrame: Pre-intervention: 1 to 3 weeks post fracture (T1) and Post-intervention: after the 8-week intervention (T2)
Secondary outcomes:
measure: Range of motion (degrees, measured with a goniometer)
timeFrame: Pre-intervention: 1 to 3 weeks post fracture (T1) and Post-intervention: after the 8-week intervention (T2)
measure: Satisfaction with the care received (score /56)
timeFrame: Post-intervention: after the 8-week intervention (T2)
measure: Cost of services from the perspective of the health system
timeFrame: Post-intervention: after the 8-week intervention (T2)
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Research Center on Aging
state: Quebec
Study officials:
affiliation: Research Centre on Aging
name: Michel Tousignant, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.
citation: Cabana F, Page C, Svotelis A, Langlois-Michaud S, Tousignant M. Is an in-home telerehabilitation program for people with proximal humerus fracture as effective as a conventional face-to face rehabilitation program? A study protocol for a noninferiority randomized clinical trial. BMC Sports Sci Med Rehabil. 2016 Aug 26;8(1):27. doi: 10.1186/s13102-016-0051-z. eCollection 2016.