Humeral Fractures, ProximalTeleFractureNCT02425267
Effectiveness of a Home Telerehabilitation Program for People With Proximal Humerus Fracture
A study testing Rehabilitation (Physiotherapy) in people with Humeral Fractures, Proximal, run by Université de Sherbrooke at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Humeral Fractures, Proximal
- What is being tested?
- Rehabilitation (Physiotherapy)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2015to 30 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Home Telerehabilitation Program for People With Proximal Humerus Fracture Treated Conservatively: a Randomized Clinical Trial.
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.
Read the 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:
- TELE intervention will be as effective as CLINIC intervention to improve upper extremity function.
- TELE intervention will be as effective as CLINIC intervention to improve deficiencies of the shoulder (increase range of motion).
- Participants who received the TELE intervention will be as satisfied of their care as participants who received the CLINICL intervention.
- 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.
- Conditions
- Humeral Fractures, Proximal
- Being tested
- Rehabilitation (Physiotherapy)
- Keywords
- Telerehabilitation
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation | Experimental | Telerehabilitation at home from a clinic Receives: Other: Rehabilitation (Physiotherapy) |
| Face-to-face intervention in a clinic | Active comparator | Conventional physiotherapy Receives: Other: Rehabilitation (Physiotherapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder function (score /100)
Constant score
Measured: 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)
flexion, extension, abduction,internal and external rotation
Measured: 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)
Health care satisfaction questionnaire
Measured: Post-intervention: after the 8-week intervention (T2)
Cost of services from the perspective of the health system
"Cost-analysis of telemedicine" from Minnesota University
Measured: Post-intervention: after the 8-week intervention (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2015 (estimated)
- Study startJun 2015
- Primary completion26 Jan 2017
- Study completion30 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Humeral Fractures, ProximalStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michel Tousignant, Université de Sherbrooke
- Investigators
- Michel Tousignant, PT, PhD, Principal investigator, Research Centre on Aging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02425267
- Sponsor's protocol ID
- 2014-725
- Acronym
- TeleFracture
- Status last verified
- May 2019
- First submitted
- 16 Apr 2015
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35727196Cabana 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.
PubMed 27570627
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Home Telerehabilitation Program for People With Proximal Humerus Fracture Treated Conservatively: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT02425267
- Acronym / sponsor ID
- TeleFracture / 2014-725
- Conditions
- Humeral Fractures, Proximal
- Keywords
- Telerehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- 26 Jan 2017 (actual)
- Study completion
- 30 Mar 2017 (actual)
- First posted
- 23 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- TELE intervention will be as effective as CLINIC intervention to improve upper extremity function.
- TELE intervention will be as effective as CLINIC intervention to improve deficiencies of the shoulder (increase range of motion).
- Participants who received the TELE intervention will be as satisfied of their care as participants who received the CLINICL intervention.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation | Experimental | Other: Rehabilitation (Physiotherapy)Telerehabilitation at home from a clinic |
| Face-to-face intervention in a clinic | Active comparator | Other: Rehabilitation (Physiotherapy)Conventional physiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabilitation (Physiotherapy)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. | Other | Face-to-face intervention in a clinic, Telerehabilitation |
Primary outcome
Shoulder function (score /100)
Time frame: Pre-intervention: 1 to 3 weeks post fracture (T1) and Post-intervention: after the 8-week intervention (T2)
Constant score
3 secondary outcomes
Range of motion (degrees, measured with a goniometer)
Time frame: 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)
Time frame: Post-intervention: after the 8-week intervention (T2)
Cost of services from the perspective of the health system
Time frame: Post-intervention: after the 8-week intervention (T2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
- Derived from this study: PubMed 35727196Handoll 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.
- Derived from this study: PubMed 27570627Cabana 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel Tousignant, PT, PhD principal investigator
Research Centre on Aging
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation (Physiotherapy) in people with Humeral Fractures, Proximal, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder function (score /100) (time frame: Pre-intervention: 1 to 3 weeks post fracture (T1) and Post-intervention: after the 8-week intervention (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02425267, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2019.