Condition category
Surgery
Date applied
09/09/2009
Date assigned
18/09/2009
Last edited
07/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.ulaval.ca/

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

Federal/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

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25840501

Publication citations

Additional files

Editorial Notes