ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT03047252
Date of registration:	03/02/2017
Prospective Registration:	No
Primary sponsor:	Sword Health, SA
Public title:	Rehabilitation for Total Knee Replacement: a Novel Biofeedback System Versus Conventional Home-based Rehabilitation
Scientific title:	Home-based Rehabilitation With A Novel Digital Biofeedback System Versus Conventional Rehabilitation After Total Knee Replacement: a Feasibility Study
Date of first enrolment:	December 19, 2016
Target sample size:	69
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT03047252
Study type:	Interventional
Study design:	Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
Phase:	N/A

Countries of recruitment
Portugal

Contacts

Name:	Fernando D Correia, MD
Address:
Telephone:
Email:
Affiliation:	Sword Health, SA

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients over 18 years old

- Clinical and imaging evidence of knee osteoarthritis

- Indication for total knee replacement according to the patient´s orthopedic surgeon

- Ability to walk unaided, with unilateral or bilateral support

- Availability of a carer to assist the patient after surgery

Exclusion Criteria:

- Patients admitted for revision of total knee replacement

- Contralateral hip or knee osteoarthritis severely limiting patient mobility and
ability to comply with a rehabilitation program

- Aphasia, dementia or psychiatric comorbidity interfering with the communication or
compliance to the rehabilitation process

- Respiratory, cardiac, metabolic or other condition incompatible with at least 30
minutes of light to moderate physical activity

- Major medical complications occurring after surgery that prevent the discharge of the
patient within 10 days after the surgery

- Other medical and/or surgical complications that prevent the patient from complying
with a rehabilitation program

- Blind and/or illiterate patients

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Arthropathy of Knee

Knee Osteoarthritis

Intervention(s)

Device: Home-based rehabilitation with a digital biofeedback system

Other: Conventional Home-based rehabilitation

Primary Outcome(s)

Change in the Timed up And Go Test score [Time Frame: Baseline; 4 and 8 weeks after initiation of rehabilitation program and then at 3 and 6 months after surgery]

Secondary Outcome(s)

Change in Knee Range of Motion (degrees) [Time Frame: Baseline; 4 and 8 weeks after initiation of rehabilitation program and then at 3 and 6 months after surgery]

Change in Knee injury and Osteoarthritis Outcome Score (KOOS) [Time Frame: Baseline; 4 and 8 weeks after initiation of rehabilitation program and then at 3 and 6 months after surgery]

Secondary ID(s)

SH-TKR-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Hospital da Prelada

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.