Hip OsteoarthritisNCT03648060
Efficacy of a Digital Biofeedback System for Home-based Rehabilitation After Total Joint Replacement
A study testing Digital kinematic biofeedback system in people with Hip Osteoarthritis and Knee Osteoarthritis, run by Sword Health, SA at 1 site in Portugal.
Trial summary
The study was designed to assess the efficacy of a home-based rehabilitation program using a digital kinematic biofeedback system after total hip or knee replacement. This is a single-arm prospective study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Osteoarthritis, Knee Osteoarthritis
- What is being tested?
- Digital kinematic biofeedback system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 sitePortugal
- Study dates
- 8 Oct 2018to 15 May 2020
- 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
- Clinical and imaging evidence of hip/knee osteoarthritis
- Indication for total hip/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 hip/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.
About this study
Official title: Efficacy of a Home-based Rehabilitation Program Performed Through a Digital Kinematic Biofeedback System After Total Hip or Knee Replacement: a Single-arm, Prospective, Open-label Study
The study was designed to assess the efficacy of a home-based rehabilitation program using a digital kinematic biofeedback system after total hip or knee replacement.
This is a single-arm prospective study. Patients will be enrolled pre-operatively and will perform an 8-week rehabilitation program starting between day 7 and 10 after surgery.
Read more
This program will consist of rehabilitation sessions performed independently by the patient at under remote monitoring from a physical therapist.
Outcomes will be measured at baseline, 4 weeks into the rehabilitation program and at the end of the program.
The primary outcome is the change in patient performance measure through the Timed-up-and-Go (TUG) test in comparison with the pre-operative score. Secondary outcomes will be measured in terms of: a) patient reported outcomes (Hip or Knee Osteoarthritis Outcome Score) and b) range of motion of the relevant joint (hip or knee).
- Conditions
- Hip Osteoarthritis, Knee Osteoarthritis
- Being tested
- Digital kinematic biofeedback system
- Medical subject headings
- Osteoarthritis, Hip, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital kinematic 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 by the therapist and edited according to patient evolution.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Home-based rehabilitation sessions performed with the digital kinematic 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: Digital kinematic biofeedback system |
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 weeks into the rehabilitation program and at the end of the program (week 8)
Secondary outcomes (2)
Change in the Hip Osteoarthritis Outcome Score/Knee Osteoarthritis Outcome Score
The HOOS/KOOS are standardized and validated patient outcome scores that assess functional limitation in patient with hip/knee osteoarthritis
Measured: Baseline, 4 weeks into the rehabilitation program and at the end of the program (week 8)
Change in Hip/Knee Range of Motion
This will be measured (in degrees) automatically by the device
Measured: Baseline, 4 weeks into the rehabilitation program and at the end of the program (week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start8 Oct 2018
- Primary completion15 May 2020
- Study completion15 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 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, SARosmaninho Seabra, MD, Study chair, Hospital da Prelada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648060
- Sponsor's protocol ID
- SH-SA-TJR-01
- Status last verified
- Mar 2020
- First submitted
- 23 Aug 2018
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Home-based Rehabilitation Program Performed Through a Digital Kinematic Biofeedback System After Total Hip or Knee Replacement: a Single-arm, Prospective, Open-label Study
- ClinicalTrials.gov ID
- NCT03648060
- Acronym / sponsor ID
- SH-SA-TJR-01
- Conditions
- Hip Osteoarthritis, Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Sword Health, SAIndustry (pharma, biotech, devices)
- Collaborators
- Hospital da Prelada
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 27 Aug 2018 (actual)
- 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 assess the efficacy of a home-based rehabilitation program using a digital kinematic biofeedback system after total hip or knee replacement.
This is a single-arm prospective study. Patients will be enrolled pre-operatively and will perform an 8-week rehabilitation program starting between day 7 and 10 after surgery.
This program will consist of rehabilitation sessions performed independently by the patient at under remote monitoring from a physical therapist.
Outcomes will be measured at baseline, 4 weeks into the rehabilitation program and at the end of the program.
The primary outcome is the change in patient performance measure through the Timed-up-and-Go (TUG) test in comparison with the pre-operative score. Secondary outcomes will be measured in terms of: a) patient reported outcomes (Hip or Knee Osteoarthritis Outcome Score) and b) range of motion of the relevant joint (hip or knee).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Digital kinematic biofeedback systemHome-based rehabilitation sessions performed with the digital kinematic 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical and imaging evidence of hip/knee osteoarthritis
- Indication for total hip/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 hip/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 |
|---|---|---|
| Digital kinematic 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 by the therapist and edited according to patient evolution. | Device | Experimental group |
Primary outcome
Change in the Timed up and Go Test score
Time frame: Baseline, 4 weeks into the rehabilitation program and at the end of the program (week 8)
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 the Hip Osteoarthritis Outcome Score/Knee Osteoarthritis Outcome Score
Time frame: Baseline, 4 weeks into the rehabilitation program and at the end of the program (week 8)
Change in Hip/Knee Range of Motion
Time frame: Baseline, 4 weeks into the rehabilitation program and at the end of the program (week 8)
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 22 Oct 2020.
- Individual participant dataSharing planned: Yes. 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
Rosmaninho Seabra, MD study chair
Hospital da Prelada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital kinematic biofeedback system in people with Hip Osteoarthritis and Knee Osteoarthritis, 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 4 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 22 Oct 2020. 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 weeks into the rehabilitation program and at the end of the program (week 8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2020.