NCT06238960

Brief Summary

Total arthroplasty (THA) is the treatment of choice for severe osteoarthritis of the hip joint. Following this type of intervention, a multidisciplinary rehabilitation approach allows you to reduce pain and improve the ability to carry out activities of daily living (ADL), but it is not clear what the optimal rehabilitation program is. Recently, the use of telerehabilitation has increased over the years. Specifically, in treatment of patients following THA surgery, telerehabilitation is able to give similar results to the treatment performed in person terms of pain and function. The aim of this study is to verify whether telerehabilitation associated with In-person treatment is comparable in terms of pain, recovery functionality and patient participation and satisfaction, compared to those provided by rehabilitation alone in the presence of patients undergoing THA surgery.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Feb 2024Dec 2026

First Submitted

Initial submission to the registry

January 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 2, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

February 10, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2026

Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

2.8 years

First QC Date

January 26, 2024

Last Update Submit

February 19, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Hip disability and Osteoarthritis Outcome score (HOOS)

    The HOOS is a 40-item self-report questionnaire with 5 subscales. A normalized score is calculated for each subscale with 0 indicating extreme symptoms and 100 representing no symptoms.

    At baseline (day 0)

  • Hip disability and Osteoarthritis Outcome score (HOOS)

    The HOOS is a 40-item self-report questionnaire with 5 subscales. A normalized score is calculated for each subscale with 0 indicating extreme symptoms and 100 representing no symptoms.

    After 8 weeks

  • Hip disability and Osteoarthritis Outcome score (HOOS)

    The HOOS is a 40-item self-report questionnaire with 5 subscales. A normalized score is calculated for each subscale with 0 indicating extreme symptoms and 100 representing no symptoms.

    After 12 weeks

Secondary Outcomes (4)

  • Timed Up and GO (TUG)

    After 8 weeks

  • Timed Up and GO (TUG)

    After 12 weeks

  • Harris Hip Score (HHS)

    After 8 weeks

  • Harris Hip Score (HHS)

    After 12 weeks

Study Arms (2)

Telerehabilitation

EXPERIMENTAL

the patients who will be randomized and subjected to the experimental treatment will undergo a physiotherapy treatment with a biweekly frequency which will be started at the same times as the standard group. After the sixth session, the process will continue through telerehabilitation until the end of outpatient treatment.

Other: Telerehabilitation

traditional physiotherapy

ACTIVE COMPARATOR

Patients who will be randomized and subjected to standard treatment (usual care at our clinic) will undergo physiotherapy treatment on a bi-weekly basis in person.

Other: Traditional rehabilitation

Interventions

the patient will undergo 10 session of tele rehabilitation in continuity with traditional physiotherapy

Telerehabilitation

the patient will undergo 16 session of outpatient physiotherapy rehabilitation

traditional physiotherapy

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having undergone total hip replacement surgery (THA)
  • Start outpatient treatment within 7 days of discharge from the Orthopedic Department
  • Age between 50 and 80 years.
  • Continuation of rehabilitation treatments at the IOR Physical Medicine and Rehabilitation service in Argenta.
  • The subjects or any caregivers must be able to use an electronic device (PC, tablet, smartphone).

You may not qualify if:

  • patients undergoing revision of previous prosthesis surgery
  • difficulty understanding the Italian language/language barrier
  • unavailability stable wi-fi connection by the patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Istituto ortopedico Rizzoli

Bologna, Italia, 40136, Italy

RECRUITING

Related Publications (2)

  • Sadiq S, Ahmad A, Ahmed A, Khan I, Asim HM, Aziz A. Role of tele-rehabilitation in patients following total hip replacement: Systematic review of clinical trials. J Pak Med Assoc. 2022 Jan;72(1):101-107. doi: 10.47391/JPMA.832.

  • Nelson M, Bourke M, Crossley K, Russell T. Telerehabilitation is non-inferior to usual care following total hip replacement - a randomized controlled non-inferiority trial. Physiotherapy. 2020 Jun;107:19-27. doi: 10.1016/j.physio.2019.06.006. Epub 2019 Jun 25.

MeSH Terms

Interventions

Telerehabilitation

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Central Study Contacts

Marco Ruggiero

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2024

First Posted

February 2, 2024

Study Start

February 10, 2024

Primary Completion (Estimated)

November 10, 2026

Study Completion (Estimated)

December 10, 2026

Last Updated

February 23, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Locations