Effectiveness of in-home telerehabilitation service following knee arthroplasty

ISRCTN	ISRCTN66285945
DOI	https://doi.org/10.1186/ISRCTN66285945
Secondary identifying numbers	MCT-91011

Submission date: 09/09/2009
Registration date: 18/09/2009
Last edited: 07/04/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Hélène Moffet
Scientific

Programme de physiothérapie
Pavillon Ferdinand-Vandry, bureau 4463
Département de réadaptation, Faculté de médecine
Université Laval
Québec
G1K 7P4
Canada

Phone	+1 418 656 2131 ext. 5588
Email	helene.moffet@rea.ulaval.ca

Study information

Study design	Multicentre randomised controlled clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Effectiveness of in-home telerehabilitaiton service following knee arthroplasty: a multicentric clinical trial
Study acronym	TelAge
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
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 study start date	01/09/2009
Completion date	31/08/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	204 participants
Key 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
Key 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
Date of first enrolment	01/09/2009
Date of final enrolment	31/08/2011

Locations

Countries of recruitment

Canada

Study participating centre

Université Laval

Québec
G1K 7P4
Canada

Sponsor information

Laval University (Canada)
University/education

c/o Dr Hélène Moffet
Programme de physiothérapie
Pavillon Ferdinand-Vandry, bureau 4463
Département de réadaptation
Faculté de médecine
Québec
G1K 7P4
Canada

Phone	+1 (0)418 656 2131 ext. 5588
Email	helene.moffet@rea.ulaval.ca
Website	http://www.ulaval.ca/
"ROR"	https://ror.org/04sjchr03

Funders

Funder type

Research organisation

Canadian Institutes of Health Research
Government organisation / National government

Alternative name(s): Instituts de Recherche en Santé du Canada, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR, IRSC
Location: Canada

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	31/03/2015		Yes	No