Hip OsteoarthritisNCT03045549
Digital Biofeedback System Versus Conventional Home-based Rehabilitation After Total Hip Replacement
A study testing Digital biofeedback system and Conventional home-based rehabilitation in people with Hip Osteoarthritis and Hip Arthrosis, run by Sword Health, SA at 1 site in Portugal.
Trial summary
The study was designed to compare the clinical outcomes of a home-based rehabilitation program using a novel digital biofeedback system against conventional home-based rehabilitation after total hip replacement This system allows the patients to perform independent rehabilitation sessions at home, under remote… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Osteoarthritis, Hip Arthrosis
- What is being tested?
- 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
- 66 participants
- Where
- 1 sitePortugal
- Study dates
- 19 Dec 2016to 20 Jul 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 hip osteoarthritis
- Indication for total hip 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 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 7 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 Digital Biofeedback System Versus Conventional Rehabilitation After Total Hip Replacement: a Pilot Study
The study was designed to compare the clinical outcomes of a home-based rehabilitation program using a novel digital biofeedback system against conventional home-based rehabilitation after total hip replacement This system allows the patients to perform independent rehabilitation sessions at home, under remote monitoring from the clinical team. The investigators hypothesise that the clinical outcomes of a home-based rehabilitation program will be at least similar to the outcomes of a traditional home-based rehabilitation with face-to-face sessions. This is a single-center, prospective, parallel-group pilot study with active comparator. Patients will be enrolled pre-operatively and then divided into 2 groups: experimental group and conventional rehabilitation group. Both groups will perform an 8-week rehabilitation program starting between day 7 and 10 after surgery.
The experimental group will perform daily exercise sessions at home using the system, under remote monitoring from a physical therapist. The conventional rehabilitation group will perform 3 home-based rehabilitation sessions per week, each with 1h duration, given by a physical therapist.
Outcomes will be measured at weeks 4 and 8 and then at 3 and 6 months. The primary outcome is the change in patient performance measured by the Timed-up-and-Go (TUG) test between in comparison with the pre-operative score. Secondary outcomes will be measured in terms of: a) Hip Osteoarthritis Outcome Score (HOOS); b) range of motion of the hip joint (lying flexion/abduction; standing flexion/adbuction/hyperextension)
- Conditions
- Hip Osteoarthritis, Hip Arthrosis
- Being tested
- Digital biofeedback system, Conventional home-based rehabilitation
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 0-6) Open kinetic chain exercises without added resistance: lying, sitting and standing (with support) Strengthening of hip flexors and abductors (mainly) Ice pack application STAGE 2 (weeks 7-8) Open kinetic chain exercises with added resistance: lying, sitting (high chair) and standing (with progression to standing without support) Strengthening of hip flexors and abductors (mainly) Ice pack application after each session
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 0-6) Soft tissue massage Active assisted mobilization of the hip joint to increase range of motion (avoiding internal rotation and adduction) Gait training with bilateral assistive devices Isometric exercises progressing to open chain, low-impact, concentric exercises with strengthening of hip abductors and flexors Ice pack application STAGE 2 (weeks 7-8) Soft tissue massage Gait training with progressive withdrawal of assistive devices Balance exercises with progression to one-leg support Open-chain strengthening exercises against resistance with progression to closed-chain exercises Ice pack application
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Home-based rehabilitation sessions performed with the digital biofeedback system. Patients will be instructed to perform exercise sessions at least 5 days a week, but compliance to this schedule is not mandatory. Receives: Device: Digital biofeedback system |
| Conventional rehabilitation group | Active comparator | Home-based rehabilitation sessions provided by a Physical Therapist, 3 times a week, each with 1h duration. Patients will be instructed to perform 2 additional unsupervised sessions per week, but compliance to these sessions is not mandatory. 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 Hip injury and Osteoarthritis Outcome Score (KOOS)
The HOOS is a standardized and validated patient outcome score that assesses functional limitation in patients with hip problems.
Measured: Baseline; 4 and 8 weeks after initiation of rehabilitation program and then at 3 and 6 months after surgery
Change in the Range of Motion (degrees)
Change in the hip range of motion (lying flexion/adbuction; standing flexion/abduction/hyperextension) 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 posted7 Feb 2017 (estimated)
- Study start19 Dec 2016
- Primary completion20 Jul 2018
- Study completion20 Jul 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 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 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
- NCT03045549
- Sponsor's protocol ID
- SH-THR-01
- Status last verified
- Feb 2019
- First submitted
- 3 Feb 2017
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol and study aggregate results (including anonymised individual patient data) will be made available
Publications
Dias Correia F, Nogueira A, Magalhaes I, Guimaraes J, Moreira M, Barradas I, Molinos M, Teixeira L, Pires J, Seabra R, Lains J, Bento V. Digital Versus Conventional Rehabilitation After Total Hip Arthroplasty: A Single-Center, Parallel-Group Pilot Study. JMIR Rehabil Assist Technol. 2019 Jun 21;6(1):e14523. doi: 10.2196/14523.
PubMed 31228176
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Rehabilitation With A Digital Biofeedback System Versus Conventional Rehabilitation After Total Hip Replacement: a Pilot Study
- ClinicalTrials.gov ID
- NCT03045549
- Acronym / sponsor ID
- SH-THR-01
- Conditions
- Hip Osteoarthritis, Hip Arthrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Sword Health, SAIndustry (pharma, biotech, devices)
- Collaborators
- Hospital da Prelada
- Study start
- 19 Dec 2016 (actual)
- Primary completion
- 20 Jul 2018 (actual)
- Study completion
- 20 Jul 2018 (actual)
- First posted
- 7 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 compare the clinical outcomes of a home-based rehabilitation program using a novel digital biofeedback system against conventional home-based rehabilitation after total hip replacement This system allows the patients to perform independent rehabilitation sessions at home, under remote monitoring from the clinical team. The investigators hypothesise that the clinical outcomes of a home-based rehabilitation program will be at least similar to the outcomes of a traditional home-based rehabilitation with face-to-face sessions. This is a single-center, prospective, parallel-group pilot study with active comparator. Patients will be enrolled pre-operatively and then divided into 2 groups: experimental group and conventional rehabilitation group. Both groups will perform an 8-week rehabilitation program starting between day 7 and 10 after surgery.
The experimental group will perform daily exercise sessions at home using the system, under remote monitoring from a physical therapist. The conventional rehabilitation group will perform 3 home-based rehabilitation sessions per week, each with 1h duration, given by a physical therapist.
Outcomes will be measured at weeks 4 and 8 and then at 3 and 6 months. The primary outcome is the change in patient performance measured by the Timed-up-and-Go (TUG) test between in comparison with the pre-operative score. Secondary outcomes will be measured in terms of: a) Hip Osteoarthritis Outcome Score (HOOS); b) range of motion of the hip joint (lying flexion/abduction; standing flexion/adbuction/hyperextension)
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: Digital biofeedback systemHome-based rehabilitation sessions performed with the digital biofeedback system. Patients will be instructed to perform exercise sessions at least 5 days a week, but compliance to this schedule is not mandatory. |
| Conventional rehabilitation group | Active comparator | Other: Conventional home-based rehabilitationHome-based rehabilitation sessions provided by a Physical Therapist, 3 times a week, each with 1h duration. Patients will be instructed to perform 2 additional unsupervised sessions per week, but compliance to these sessions is not mandatory. |
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 hip osteoarthritis
- Indication for total hip 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 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 7 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 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 0-6) Open kinetic chain exercises without added resistance: lying, sitting and standing (with support) Strengthening of hip flexors and abductors (mainly) Ice pack application STAGE 2 (weeks 7-8) Open kinetic chain exercises with added resistance: lying, sitting (high chair) and standing (with progression to standing without support) Strengthening of hip flexors and abductors (mainly) Ice pack application after each session | 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 0-6) Soft tissue massage Active assisted mobilization of the hip joint to increase range of motion (avoiding internal rotation and adduction) Gait training with bilateral assistive devices Isometric exercises progressing to open chain, low-impact, concentric exercises with strengthening of hip abductors and flexors Ice pack application STAGE 2 (weeks 7-8) Soft tissue massage Gait training with progressive withdrawal of assistive devices Balance exercises with progression to one-leg support Open-chain strengthening exercises against resistance with progression to closed-chain exercises 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 Hip 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 the 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 5 Feb 2019.
- Derived from this study: PubMed 31228176Dias Correia F, Nogueira A, Magalhaes I, Guimaraes J, Moreira M, Barradas I, Molinos M, Teixeira L, Pires J, Seabra R, Lains J, Bento V. Digital Versus Conventional Rehabilitation After Total Hip Arthroplasty: A Single-Center, Parallel-Group Pilot Study. JMIR Rehabil Assist Technol. 2019 Jun 21;6(1):e14523. doi: 10.2196/14523.
- Individual participant dataSharing planned: Yes. Study protocol and study aggregate results (including anonymised individual patient data) will be made available
Related trials for Hip Osteoarthritis
Recruiting
FRONT Block for Quality of Recovery After Total Hip Arthroplasty
Osteoarthritis of the Hip, Postoperative Pain
RecruitingObservational study
Post-Market Clinical Follow-up of Intra-Articular Hyaluronic Acid in Hip Osteoarthritis
Hip OA
Not yet recruitingObservational study
Clinical Validation of SMARTDIAGO for Remote Functional Assessment of Musculoskeletal Conditions
Knee Osteoarthristis, Hip Osteoarthritis
Not yet recruiting
DEXA Bone Density Analysis of the CoreHip® Prosthesis System
Primary Osteoarthritis, Cartilage Degeneration
RecruitingObservational study
Z1 Hip System: Post-Market Clinical Follow Up Study
Hip Osteoarthritis, Acute Traumatic Fracture of the Femoral Head or Neck
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 Digital biofeedback system and Conventional home-based rehabilitation in people with Hip Osteoarthritis and Hip Arthrosis, 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 5 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 NCT03045549, 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 5 Feb 2019; AzTrials last refreshed its copy on 1 Nov 2026.