NCT02425267

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 23, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2017

Completed
Last Updated

May 28, 2019

Status Verified

May 1, 2019

Enrollment Period

1.7 years

First QC Date

April 16, 2015

Last Update Submit

May 23, 2019

Conditions

Humeral Fractures, Proximal

Keywords

Telerehabilitation

Outcome Measures

Primary Outcomes (1)

  • Shoulder function (score /100)

    Constant score

    Pre-intervention: 1 to 3 weeks post fracture (T1) and Post-intervention: after the 8-week intervention (T2)

Secondary Outcomes (3)

  • Range of motion (degrees, measured with a goniometer)

    Pre-intervention: 1 to 3 weeks post fracture (T1) and Post-intervention: after the 8-week intervention (T2)

  • Satisfaction with the care received (score /56)

    Post-intervention: after the 8-week intervention (T2)

  • Cost of services from the perspective of the health system

    Post-intervention: after the 8-week intervention (T2)

Study Arms (2)

Telerehabilitation

EXPERIMENTAL

Telerehabilitation at home from a clinic

Other: Rehabilitation (Physiotherapy)

Face-to-face intervention in a clinic

ACTIVE COMPARATOR

Conventional physiotherapy

Other: Rehabilitation (Physiotherapy)

Interventions

Rehabilitation (Physiotherapy)OTHER

The training program will be carried out twice a day, and at every day during the eight-week program, either by telerehabilitation or in the clinic or by autonomous unsupervised way. During weeks 1, 3 and 5, the patient will perform his/her exercises twice a week by telerehabilitation/clinic and the other without supervision. During the other weeks (2, 4, 6, 7, 8), the patient will benefit from one exercise session by telerehabilitation/clinic per week and will perform all other without supervision. Supervised sessions allow the therapist and the patient to adjust the program in case of problems and to ensure a smooth implementation of the program.

Face-to-face intervention in a clinicTelerehabilitation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Center on Aging

Sherbrooke, Quebec, J1H 4C4, Canada

Location

Related Publications (2)

  • 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.

    PMID: 35727196DERIVED

  • 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.

    PMID: 27570627DERIVED

MeSH Terms

Conditions

Shoulder Fractures

Interventions

RehabilitationPhysical Therapy Modalities

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesShoulder Injuries

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Michel Tousignant, PT, PhD

    Research Centre on Aging

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 16, 2015

First Posted

April 23, 2015

Study Start

June 1, 2015

Primary Completion

January 26, 2017

Study Completion

March 30, 2017

Last Updated

May 28, 2019

Record last verified: 2019-05

Locations

CA(1)