Knee OsteoarthritisNCT03047252
Rehabilitation for Total Knee Replacement: a Novel Biofeedback System Versus Conventional Home-based Rehabilitation
A study testing Home-based rehabilitation with a digital biofeedback system and Conventional Home-based rehabilitation in people with Knee Osteoarthritis and Arthropathy of Knee, run by Sword Health, SA at 1 site in Portugal.
Trial summary
The study was designed to test patient acceptance and system usability and to assess clinical outcomes of a home-based rehabilitation program using a novel kinematic biofeedback system in the rehabilitation after total knee replacement versus conventional rehabilitation, This system allows the patients to perform… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis, Arthropathy of Knee
- What is being tested?
- Home-based rehabilitation with a digital biofeedback system and Conventional Home-based rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 sitePortugal
- Study dates
- 19 Dec 2016to 27 May 2018
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Hospital da Prelada - Dr. Domingos Braga da Cruz
Porto, 4250-449
About this study
Official title: Home-based Rehabilitation With A Novel Digital Biofeedback System Versus Conventional Rehabilitation After Total Knee Replacement: a Feasibility Study
The study was designed to test patient acceptance and system usability and to assess clinical outcomes of a home-based rehabilitation program using a novel kinematic biofeedback system in the rehabilitation after total knee replacement versus conventional rehabilitation, This system allows the patients to perform independent rehabilitation sessions at home, under remote monitoring from the clinical team.
The investigators hypothesize that the system will be well received by patients and that the clinical outcomes will be at least similar those of conventional rehabilitation.
Read more
This is a quasi-randomized controlled trial with active comparator. Patients will be enrolled pre-operatively and divided into 2 groups: experimental group and conventional rehabilitation group according to geographical criteria. Both groups will perform 8 weeks of rehabilitation starting between day 7 and 10 after surgery.
The experimental group will perform daily rehabilitation sessions at home using the system, under remote monitoring from a physical therapist. The conventional rehabilitation group will perform 1h rehabilitation sessions 3 times a week, at home, given by a physical therapist.
The following feasibility outcomes will be registered: enrollment rate, retention rate (drop-outs), compliance to the program, independence of use, need for therapist contact and patient satisfaction.
Clinical outcomes will be measured at weeks 4 and 8 and then at 3 and 6 months. The primary outcome will be measured in terms of patient performance in the Timed-up-and-Go (TUG) test in comparison with the pre-operative score. Secondary outcomes will be measured in terms of: b) Knee Osteoarthritis Outcome Score); c) range of motion of the knee joint.
- Conditions
- Knee Osteoarthritis, Arthropathy of Knee
- Being tested
- Home-based rehabilitation with a digital biofeedback system, Conventional Home-based rehabilitation
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based rehabilitation with a digital biofeedback systemDevice
Also called SWORD Phoenix
The system will be used independently by the patients to perform rehabilitation sessions at home, under remote monitoring from the clinical team. A tailored rehabilitation program will be prescribed, based on the following principles:
STAGE 1 (Weeks 0-2) Open kinetic chain exercises without added resistance: lying, sitting and standing (with support) Strengthening of hip flexors and extensors Ice pack application after each session and throughout the day as needed STAGE 2 (weeks 3-6) Open kinetic chain exercises with added resistance, progressing to closed kinetic chain exercises, with strengthening of knee flexors and extensors and knee stabilization Progression to standing exercises without support lying, sitting and standing (with support) Exercises with steps Ice pack application after each session and throughout the day as needed STAGE 3 (Weeks 7-8) Eccentric strengthening exercises Exercises involving steps Multi-directional exercises
Conventional Home-based rehabilitationOther
Patients will perform 3 weekly rehabilitation sessions, with a duration of 1 hour, for 8 weeks, provided by a physical therapist. The rehabilitation program will respect the following principles:
STAGE 1 (Weeks 0-2) Soft tissue massage Active assisted mobilisation of the knee to increase range of motion Gait training with bilateral support Open kinetic chain exercises without added resistance Strengthening of hip flexors and extensors Ice pack application STAGE 2 (weeks 3-6) Soft tissue massage Active assisted mobilisation of the knee to increase range of motion Open kinetic chain exercises with added resistance, progressing to closed kinetic chain exercises, with strengthening of knee flexors/ extensors and knee stabilisation Gait training with progressive withdrawal of external support Ice pack application STAGE 3 (Weeks 7-8) Eccentric strengthening exercises Exercises involving steps Weight-bearing exercises on uneven surfaces Ice pack application
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Home-based rehabilitation sessions performed with the novel digital biofeedback system.
Patients will be instructed to perform exercise sessions in at least 5 days per week, but compliance to this schedule is not mandatory per protocol. Receives: Device: Home-based rehabilitation with a digital biofeedback system |
| Conventional rehabilitation group | Active comparator | Home-based rehabilitation sessions provided by a Physical Therapist, 3 times a week for 8 weeks. Each session will have a duration of 60 minutes. Patients will be instructed to perform additional unsupervised sessions in at least two other days, but compliance to these extra sessions is not mandatory per protocol. Receives: Other: Conventional Home-based rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Timed up And Go Test score
The timed up and go requires a patient to rise from a chair walk three meters around a piece of tape and return to the chair again as quickly as possible.
Measured: Baseline; 4 and 8 weeks after initiation of rehabilitation program and then at 3 and 6 months after surgery
Secondary outcomes (2)
Change in Knee injury and Osteoarthritis Outcome Score (KOOS)
The KOOS is a standardized and validated patient outcome score that assesses functional limitation in patient with knee problems.
Measured: Baseline; 4 and 8 weeks after initiation of rehabilitation program and then at 3 and 6 months after surgery
Change in Knee Range of Motion (degrees)
Change in knee flexion/extension measured in degrees
Measured: Baseline; 4 and 8 weeks after initiation of rehabilitation program and then at 3 and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study start19 Dec 2016
- Primary completion27 May 2018
- Study completion27 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sword Health, SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital da Prelada
- Responsible party
- Sponsor
- Investigators
- Fernando D Correia, MD, Principal investigator, Sword Health, SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03047252
- Sponsor's protocol ID
- SH-TKR-01
- Status last verified
- Feb 2019
- First submitted
- 3 Feb 2017
- Last updated
- 6 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol will be made available in PDF format. Aggregate study results, with anonymised individual participant data will be made available in Excel format
Publications
Correia FD, Nogueira A, Magalhaes I, Guimaraes J, Moreira M, Barradas I, Molinos M, Teixeira L, Tulha J, Seabra R, Lains J, Bento V. Medium-Term Outcomes of Digital Versus Conventional Home-Based Rehabilitation After Total Knee Arthroplasty: Prospective, Parallel-Group Feasibility Study. JMIR Rehabil Assist Technol. 2019 Feb 28;6(1):e13111. doi: 10.2196/13111.
PubMed 30816849
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Rehabilitation With A Novel Digital Biofeedback System Versus Conventional Rehabilitation After Total Knee Replacement: a Feasibility Study
- ClinicalTrials.gov ID
- NCT03047252
- Acronym / sponsor ID
- SH-TKR-01
- Conditions
- Knee Osteoarthritis, Arthropathy of Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Sword Health, SAIndustry (pharma, biotech, devices)
- Collaborators
- Hospital da Prelada
- Study start
- 19 Dec 2016 (actual)
- Primary completion
- 27 May 2018 (actual)
- Study completion
- 27 May 2018 (actual)
- First posted
- 8 Feb 2017 (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 study was designed to test patient acceptance and system usability and to assess clinical outcomes of a home-based rehabilitation program using a novel kinematic biofeedback system in the rehabilitation after total knee replacement versus conventional rehabilitation, This system allows the patients to perform independent rehabilitation sessions at home, under remote monitoring from the clinical team.
The investigators hypothesize that the system will be well received by patients and that the clinical outcomes will be at least similar those of conventional rehabilitation.
This is a quasi-randomized controlled trial with active comparator. Patients will be enrolled pre-operatively and divided into 2 groups: experimental group and conventional rehabilitation group according to geographical criteria. Both groups will perform 8 weeks of rehabilitation starting between day 7 and 10 after surgery.
The experimental group will perform daily rehabilitation sessions at home using the system, under remote monitoring from a physical therapist. The conventional rehabilitation group will perform 1h rehabilitation sessions 3 times a week, at home, given by a physical therapist.
The following feasibility outcomes will be registered: enrollment rate, retention rate (drop-outs), compliance to the program, independence of use, need for therapist contact and patient satisfaction.
Clinical outcomes will be measured at weeks 4 and 8 and then at 3 and 6 months. The primary outcome will be measured in terms of patient performance in the Timed-up-and-Go (TUG) test in comparison with the pre-operative score. Secondary outcomes will be measured in terms of: b) Knee Osteoarthritis Outcome Score); c) range of motion of the knee joint.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Home-based rehabilitation with a digital biofeedback systemHome-based rehabilitation sessions performed with the novel digital biofeedback system. Patients will be instructed to perform exercise sessions in at least 5 days per week, but compliance to this schedule is not mandatory per protocol. |
| Conventional rehabilitation group | Active comparator | Other: Conventional Home-based rehabilitationHome-based rehabilitation sessions provided by a Physical Therapist, 3 times a week for 8 weeks. Each session will have a duration of 60 minutes. Patients will be instructed to perform additional unsupervised sessions in at least two other days, but compliance to these extra sessions is not mandatory per protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Home-based rehabilitation with a digital biofeedback systemAlso: SWORD PhoenixThe system will be used independently by the patients to perform rehabilitation sessions at home, under remote monitoring from the clinical team. A tailored rehabilitation program will be prescribed, based on the following principles: STAGE 1 (Weeks 0-2) Open kinetic chain exercises without added resistance: lying, sitting and standing (with support) Strengthening of hip flexors and extensors Ice pack application after each session and throughout the day as needed STAGE 2 (weeks 3-6) Open kinetic chain exercises with added resistance, progressing to closed kinetic chain exercises, with strengthening of knee flexors and extensors and knee stabilization Progression to standing exercises without support lying, sitting and standing (with support) Exercises with steps Ice pack application after each session and throughout the day as needed STAGE 3 (Weeks 7-8) Eccentric strengthening exercises Exercises involving steps Multi-directional exercises | Device | Experimental group |
| Conventional Home-based rehabilitationPatients will perform 3 weekly rehabilitation sessions, with a duration of 1 hour, for 8 weeks, provided by a physical therapist. The rehabilitation program will respect the following principles: STAGE 1 (Weeks 0-2) Soft tissue massage Active assisted mobilisation of the knee to increase range of motion Gait training with bilateral support Open kinetic chain exercises without added resistance Strengthening of hip flexors and extensors Ice pack application STAGE 2 (weeks 3-6) Soft tissue massage Active assisted mobilisation of the knee to increase range of motion Open kinetic chain exercises with added resistance, progressing to closed kinetic chain exercises, with strengthening of knee flexors/ extensors and knee stabilisation Gait training with progressive withdrawal of external support Ice pack application STAGE 3 (Weeks 7-8) Eccentric strengthening exercises Exercises involving steps Weight-bearing exercises on uneven surfaces Ice pack application | Other | Conventional rehabilitation group |
Primary outcome
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
The timed up and go requires a patient to rise from a chair walk three meters around a piece of tape and return to the chair again as quickly as possible.
2 secondary outcomes
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
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
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 6 Feb 2019.
- Derived from this study: PubMed 30816849Correia FD, Nogueira A, Magalhaes I, Guimaraes J, Moreira M, Barradas I, Molinos M, Teixeira L, Tulha J, Seabra R, Lains J, Bento V. Medium-Term Outcomes of Digital Versus Conventional Home-Based Rehabilitation After Total Knee Arthroplasty: Prospective, Parallel-Group Feasibility Study. JMIR Rehabil Assist Technol. 2019 Feb 28;6(1):e13111. doi: 10.2196/13111.
- Individual participant dataSharing planned: Yes. The study protocol will be made available in PDF format. Aggregate study results, with anonymised individual participant data will be made available in Excel format
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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.
Fernando D Correia, MD principal investigator
Sword Health, SA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based rehabilitation with a digital biofeedback system and Conventional Home-based rehabilitation in people with Knee Osteoarthritis and Arthropathy of Knee, run by Sword Health, SA at 1 site in Portugal.
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 7 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 6 Feb 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 Portugal. 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?
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). 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 NCT03047252, which also lists 1 linked publication.
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 6 Feb 2019; AzTrials last refreshed its copy on 1 Nov 2026.