NCT06409312

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 10, 2024

Completed
11 days until next milestone

Study Start

First participant enrolled

May 21, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

7 months

First QC Date

May 7, 2024

Last Update Submit

May 14, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of completed training sessions and the number of repetitions per sessionweeks of training.

    after 12 weeks

Secondary Outcomes (5)

  • Intrinsic Motivation Inventory (IMI)

    Baseline, 6 weeks, 12 weeks

  • Net Promoter Score (NPS)

    6 weeks, 12 weeks

  • Post-Study System Usability Questionnaire (PSSUQ)

    6 weeks, 12 weeks

  • Hip disability and Osteoarthritis Outcome Score

    6 weeks, 12 weeks, 26 weeks

  • International Physical Activity Questionnaire

    6 weeks, 12 weeks, 26 weeks

Study Arms (1)

Akina Cloud

EXPERIMENTAL
Device: Akina Cloud

Interventions

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.

Akina Cloud

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2024

First Posted

May 10, 2024

Study Start

May 21, 2024

Primary Completion

December 31, 2024

Study Completion

May 30, 2025

Last Updated

May 16, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share