Total Hip ReplacementNCT06409312
Digital Healthcare App After Total Hip Arthroplasty
A study testing Akina Cloud in people with Total Hip Replacement, run by Schulthess Klinik.
Trial summary
This study examines the effectiveness of rehabilitation after hip replacement surgery using a specialised app called Akina Cloud. Medical professionals at the Schulthess Clinic will provide detailed information about the study. Participants must meet certain eligibility requirements. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Total Hip Replacement
- What is being tested?
- Akina Cloud
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 21 May 2024to 30 May 2025
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed Consent signed by the subject
- Unilateral initial implantation of a minimally-invasive hip endoprosthesis
- Age between 18 and 75 years old
- Ownership of a private laptop or desktop computer
- Stable internet connection at home
- Familiarity with the use of laptop or desktop computer
Who cannot join
- Bilateral initial implantation of a minimally-invasive hip endoprosthesis
- Not fluent in German or English
- Other conditions where active therapy is contraindicated
- Neurological diseases that limit the ability to walk
- Chronic lower limb pain
- Rheumatological diseases
- Other inflammatory diseases
About this study
Official title: Assessing the Feasibility of a Digital Healthcare App for Patient Rehabilitation After Total Hip Arthroplasty
This study examines the effectiveness of rehabilitation after hip replacement surgery using a specialised app called Akina Cloud. Medical professionals at the Schulthess Clinic will provide detailed information about the study. Participants must meet certain eligibility requirements. There will be time for consideration before enrolment. A demonstration of how to use the app will be provided upon agreement. Participants will be shown how to set up their profile and interact with a real therapist who will provide feedback. The initial 30-minute introduction is scheduled to take place a few days after surgery while still in hospital. Participants will be asked to complete several questionnaires. The rehabilitation process involves using the app for at least 12 weeks, at least three times a week, for 20-30 minutes per session. Direct communication with the therapist via the app is available for any queries. Follow-up questionnaires will be emailed at 6 and 12 weeks, after training, and again at 26 weeks to assess progress and feedback on the use of the app. Each session with the app lasts about 20 minutes and the questionnaire takes about 30 minutes to complete.
- Conditions
- Total Hip Replacement
- Being tested
- Akina Cloud
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Akina CloudDevice
Akina Cloud is a digital health application that supports the therapeutic training of people with musculoskeletal conditions. It provides two therapeutic training programs for patients, one for each specific indication. Patients have continuous access to these programs through Akina Cloud, allowing them to independently complete nine training sessions without supervision. A minimum of three sessions per week is recommended, but patients have the option to engage in daily sessions if preferred. These therapy programs are based on current treatment guidelines and supported by relevant scientific research. They include customizable physical exercises tailored to individual needs and difficulty levels. Patients receive audio-visual guidance during these exercise sessions to ensure proper execution. Exercise therapy has demonstrated its ability to reduce pain, improve physical function, and enhance the overall quality of life for patients suffering from back pain and hip osteoarthritis.
| Study group | Role | What they receive |
|---|---|---|
| Akina Cloud | Experimental | Not described Receives: Device: Akina Cloud |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of completed training sessions and the number of repetitions per sessionweeks of training.
Measured: after 12 weeks
Secondary outcomes (5)
Intrinsic Motivation Inventory (IMI)
Intrinsic motivation inventory (IMI) consists of 6 subscales, the items are rated on a Likert scale ranging from 1 ("not at all true") to ("very true") for each item. A higher score indicates stronger intrinsic motivation.
Measured: Baseline, 6 weeks, 12 weeks
Net Promoter Score (NPS)
The NPS is a metric used to assess customer loyalty and satisfaction by asking a single question: "How likely is it that you would recommend our company/product/service to a friend or colleague?"The scale ranges form 0 to 10. A higher score indicates stronger intrinsic motivation.
Measured: 6 weeks, 12 weeks
Post-Study System Usability Questionnaire (PSSUQ)
The Post-Study System Usability Questionnaire is a standardised questionnaire desigend to evaluate users' perceptions of the usability of a system of product after they have interacted with it.The questionnaire consists of a set of Likert-scale questions that cover various aspects of the user experience. The lower the score, the better the performance and satisfaction.
Measured: 6 weeks, 12 weeks
Hip disability and Osteoarthritis Outcome Score
The Hip disability and Osteoarthritis Outcome Score is a self-report questionnnaire with five subsets (pain, symptoms, activities of daily living, sports and recreations and quality in life). The scores range from 0 to 100, where a higehr score indicate less ssymptoms and disability.
Measured: 6 weeks, 12 weeks, 26 weeks
International Physical Activity Questionnaire
The questionnaire covers activities such as work-related, transportation, household chores, and leisure-time activities. The responses are then used to categorise individuals into different levels of physical activity, ranging from low to high.
Measured: 6 weeks, 12 weeks, 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start21 May 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ReplacementStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Schulthess Klinik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06409312
- Sponsor's protocol ID
- 2024-D0008
- Status last verified
- May 2024
- First submitted
- 7 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Feasibility of a Digital Healthcare App for Patient Rehabilitation After Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT06409312
- Acronym / sponsor ID
- 2024-D0008
- Conditions
- Total Hip Replacement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Schulthess KlinikUniversity, hospital or other
- Study start
- 21 May 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 10 May 2024 (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.
This study examines the effectiveness of rehabilitation after hip replacement surgery using a specialised app called Akina Cloud. Medical professionals at the Schulthess Clinic will provide detailed information about the study. Participants must meet certain eligibility requirements. There will be time for consideration before enrolment. A demonstration of how to use the app will be provided upon agreement. Participants will be shown how to set up their profile and interact with a real therapist who will provide feedback. The initial 30-minute introduction is scheduled to take place a few days after surgery while still in hospital. Participants will be asked to complete several questionnaires. The rehabilitation process involves using the app for at least 12 weeks, at least three times a week, for 20-30 minutes per session. Direct communication with the therapist via the app is available for any queries. Follow-up questionnaires will be emailed at 6 and 12 weeks, after training, and again at 26 weeks to assess progress and feedback on the use of the app. Each session with the app lasts about 20 minutes and the questionnaire takes about 30 minutes to complete.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Akina Cloud | Experimental | Device: Akina Cloud |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Informed Consent signed by the subject
- Unilateral initial implantation of a minimally-invasive hip endoprosthesis
- Age between 18 and 75 years old
- Ownership of a private laptop or desktop computer
- Stable internet connection at home
Key exclusion criteria (7 listed)
- Bilateral initial implantation of a minimally-invasive hip endoprosthesis
- Not fluent in German or English
- Other conditions where active therapy is contraindicated
- Neurological diseases that limit the ability to walk
- Chronic lower limb pain
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 |
|---|---|---|
| Akina CloudAkina Cloud is a digital health application that supports the therapeutic training of people with musculoskeletal conditions. It provides two therapeutic training programs for patients, one for each specific indication. Patients have continuous access to these programs through Akina Cloud, allowing them to independently complete nine training sessions without supervision. A minimum of three sessions per week is recommended, but patients have the option to engage in daily sessions if preferred. These therapy programs are based on current treatment guidelines and supported by relevant scientific research. They include customizable physical exercises tailored to individual needs and difficulty levels. Patients receive audio-visual guidance during these exercise sessions to ensure proper execution. Exercise therapy has demonstrated its ability to reduce pain, improve physical function, and enhance the overall quality of life for patients suffering from back pain and hip osteoarthritis. | Device | Akina Cloud |
Primary outcome
Number of completed training sessions and the number of repetitions per sessionweeks of training.
Time frame: after 12 weeks
5 secondary outcomes
Intrinsic Motivation Inventory (IMI)
Time frame: Baseline, 6 weeks, 12 weeks
Net Promoter Score (NPS)
Time frame: 6 weeks, 12 weeks
Post-Study System Usability Questionnaire (PSSUQ)
Time frame: 6 weeks, 12 weeks
Hip disability and Osteoarthritis Outcome Score
Time frame: 6 weeks, 12 weeks, 26 weeks
International Physical Activity Questionnaire
Time frame: 6 weeks, 12 weeks, 26 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Akina Cloud in people with Total Hip Replacement, run by Schulthess Klinik.
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 6 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: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Number of completed training sessions and the number of repetitions per sessionweeks of training. (time frame: after 12 weeks). 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 16 May 2024.