Contact information
Type
Scientific
Primary contact
Dr Hélène Moffet
ORCID ID
Contact details
Programme de physiothérapie
Pavillon Ferdinand-Vandry
bureau 4463
Département de réadaptation
Faculté de médecine
Université Laval
Québec
G1K 7P4
Canada
+1 418 656 2131 ext. 5588
helene.moffet@rea.ulaval.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCT-91011
Study information
Scientific title
Effectiveness of in-home telerehabilitaiton service following knee arthroplasty: a multicentric clinical trial
Acronym
TelAge
Study hypothesis
The principle objective of this non-inferiority clinical trial is to check if an in-home telerehabilitation approach is as effective as the standard approach of face-to-face rehabilitation and education at home in participants after a knee arthroplasty.
Ethics approval
1. Local medical ethics committee (Comité d'éthique de la recherche clinique du CHUQ-HDQ) approved on the 19th March 2009 (ref: MP-CHUQ-HD-08-010; 5.6.08.12)
2. Final approval by the REC principal, amended on July 28 2009, for the following establishments:
2.1. Hôtel-Dieu de Québec
2.2. IRDPQ (CIRRIS)
2.3. CHUS
2.4. Hôpital Jean-Talon de Montréal
2.5. Institut universitaire de gériatrie de Sherbrooke
2.6. Hôpital Saint-François-d'Assise
2.7. Hôpital Ste-Marys de Montréal
2.8. CHA, hôpital de l'Enfant-Jésus
2.9. Institut de réadaptation Gingras-Lindsay-de-Montréal (CRIR)
As of 10/09/2009, only one approval is still pending: Hôtel-Dieu Arthabaska-Érable
Study design
Multicentre randomised controlled clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Total knee arthroplasty
Intervention
The same rehabilitation intervention is given in both study groups: the one receiving the in-home telerehabilitation approach and the other, the face-to-face home visit approach. Only the delivery approach differs between groups. The rehabilitation intervention combined 16 supervised home-based treatments (mean duration of 45 minutes per treatment) with individualised home exercises performed on the days without supervised treatments. These treatments are based on a intensive functional approach to reducing impairment and improving function in daily activities. It starts the first week following hospital discharge and it is supervised by a physiotherapist over a period of 8 weeks. The type and intensity of the exercises are regularly adapted to the individuals' needs and tolerance to ensure optimal intensity of the intervention all along the treatment period.
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measure
Western Ontario and McMaster Universities Osteoarthritis (OA) Index (WOMAC) (post-operative versus pre-operative score) at four months following the exit of the hospital
Secondary outcome measures
1. Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire
2. Six-minute walk test
3. Timed Stair Test
4. Range of motion and muscle strength after knee surgery
5. Knee function during walking and rising from a chair
6. Participants' satisfaction with the intervention
Overall trial start date
01/09/2009
Overall trial end date
31/08/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Being an adult (more than 18 years) man or woman
2. Being operated for a primary total knee arthroplasty after a diagnosis of osteoarthritis
3. Returning at home after hospital discharge
4. Having access to Internet high speed connexion
5. Living in a 60-minute driving area
6. Being ambulatory with or without a walking aid
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
204 participants
Participant exclusion criteria
1. Having health conditions that could interfere with tests or rehabilitation program
2. Planning a second surgery of lower limbs within 4 months
3. Having cognitive or collaboration problems
4. Having post-operative major complications
5. Having a rest prescription for a period longer than 2 weeks
6. Having had previous surgery of the lower limbs affecting the gait pattern during the past year
Recruitment start date
01/09/2009
Recruitment end date
31/08/2011
Locations
Countries of recruitment
Canada
Trial participating centre
Université Laval
Québec
G1K 7P4
Canada
Sponsor information
Organisation
Laval University (Canada)
Sponsor details
c/o Dr Hélène Moffet
Programme de physiothérapie
Pavillon Ferdinand-Vandry
bureau 4463
Département de réadaptation
Faculté de médecine
Québec
G1K 7P4
Canada
+1 (0)418 656 2131 ext. 5588
helene.moffet@rea.ulaval.ca
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research
Alternative name(s)
Instituts de Recherche en Santé du Canada, CIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Canada
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25840501