NCT05699031

Brief Summary

The goal of this clinical trial is to compare the rehabilitation by use of a smartphone-app with the usual care of physical therapy in patients, 60 years and older, who underwent a primary shoulder arthroplasty. The main questions it aims to answer are:

  • is the outcome of rehabilitation with the app as good as the usual care?
  • is the outcome for both types of shoulder arthroplasty similar?
  • what is the usability of the app?. Participants will
  • have treatment according to the group they are allocated to
  • fill in questionnaires at specific moments during the rehabilitation stage (0 - 3 months ) and at 1 year post-surgery

Trial Health

77
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Mar 2023

Longer than P75 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 Progress89%
Mar 2023Sep 2026

First Submitted

Initial submission to the registry

December 23, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

April 12, 2024

Status Verified

April 1, 2024

Enrollment Period

3.6 years

First QC Date

December 23, 2022

Last Update Submit

April 11, 2024

Conditions

SHOULDER ARTHROPLASTYREHABILITATIONTELEREHABILITATION

Keywords

SHOULDER ARTHROPLASTYREHABILITATIONTELEREHABILITATION

Outcome Measures

Primary Outcomes (6)

  • SHOULDER PAIN AND DISABILITY INDEX (SPADI)_baseline pre-operative

    Content: 5 questions for the subscale pain and 8 questions for the disability subscale. Scoring: numeric rating scale from 1 to 10, with a maximum of 130. The total score is the sum of the sub-scores. Interpretation: The higher the score the more pain and disability. The lower the score, the better patients perceive their shoulder

    Prior to surgery

  • SHOULDER PAIN AND DISABILITY INDEX (SPADI)_baseline post-operative

    Content: 5 questions for the subscale pain and 8 questions for the disability subscale. Scoring: numeric rating scale from 1 to 10, with a maximum of 130. The total score is the sum of the sub-scores. Interpretation: The higher the score the more pain and disability. The lower the score, the better patients perceive their shoulder

    week 0

  • SHOULDER PAIN AND DISABILITY INDEX (SPADI)

    Content: 5 questions for the subscale pain and 8 questions for the disability subscale. Scoring: numeric rating scale from 1 to 10, with a maximum of 130. The total score is the sum of the sub-scores. Interpretation: The higher the score the more pain and disability. The lower the score, the better patients perceive their shoulder

    week 3

  • SHOULDER PAIN AND DISABILITY INDEX (SPADI)

    Content: 5 questions for the subscale pain and 8 questions for the disability subscale. Scoring: numeric rating scale from 1 to 10, with a maximum of 130. The total score is the sum of the sub-scores. Interpretation: The higher the score the more pain and disability. The lower the score, the better patients perceive their shoulder

    week 6

  • SHOULDER PAIN AND DISABILITY INDEX (SPADI)

    Content: 5 questions for the subscale pain and 8 questions for the disability subscale. Scoring: numeric rating scale from 1 to 10, with a maximum of 130. The total score is the sum of the sub-scores. Interpretation: The higher the score the more pain and disability. The lower the score, the better patients perceive their shoulder

    week 12

  • SHOULDER PAIN AND DISABILITY INDEX (SPADI)

    Content: 5 questions for the subscale pain and 8 questions for the disability subscale. Scoring: numeric rating scale from 1 to 10, with a maximum of 130. The total score is the sum of the sub-scores. Interpretation: The higher the score the more pain and disability. The lower the score, the better patients perceive their shoulder

    week 52

Secondary Outcomes (13)

  • ACTIVE MOBILITY (ROM) OF THE SHOULDER

    Prior to surgery, week 3, week 6, week 12, week 52

  • PASSIVE MOBILITY (ROM) OF THE SHOULDER

    Prior to surgery, week 3, week 6, week 12, week 52

  • STRENGTH

    Prior to surgery, week 3, week 6, week 12, week 52

  • CONSTANT-MURLEY SCORE

    Prior to surgery, week 3, week 6, week 12, week 52

  • ACTIVITIES OF DAILY LIVING EXTERNAL AND INTERNAL ROTATIONS (ADLEIR)

    Prior to surgery, week 3, week 6, week 12, week 52

  • +8 more secondary outcomes

Other Outcomes (6)

  • M-HEALTH APP USABILITY QUESTIONNAIRE (MAUQ)

    Week 12

  • SYSTEM USABILITY SCALE (SUS)

    Week 12

  • SINGLE EASE QUESTION (SEQ)

    Week 12

  • +3 more other outcomes

Study Arms (2)

APP-GROUP

EXPERIMENTAL

Patients allocated in the app-group will use the app to rehabilitate.

Device: APP

PHYSIO-GROUP

ACTIVE COMPARATOR

Patients allocated in the physio-group will rehabilitate according to the usual care protocol

Other: PHYSICAL THERAPY

Interventions

APPDEVICE

Patients allocated in the app-group will use the newly developed smartphone app te rehabilitate. 5 exercises are provided daily. Daily questionnaires will monitor exercise performance, VAS pain, household activities. Information modules will be sent at specific times.

APP-GROUP
PHYSICAL THERAPYOTHER

Patients allocated in the physio-group will go, twice a week, to a physical therapist of their choice to rehabilitate. The physical therapist will follow the general guidelines provided by the hospital (surgeon).

Also known as: PHYSIO-GROUP
PHYSIO-GROUP

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years and older
  • primary total shoulder arthroplasty (anatomical and reverse)
  • osteoarthritis, cuff tear arthropathy, pseudoparalysis
  • return home after discharge from hospital
  • no brace after surgery
  • sufficient verbal and written comprehension
  • hospitalization insurance

You may not qualify if:

  • revision arthroplasty
  • arthroplasty for fracture or tumor
  • neurological disease (parkinson, stroke, ...)
  • no access to smartphone, tablet or internet connectivity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Alexander Van Tongel, PhD

    University Ghent, University Hospital Ghent

    PRINCIPAL INVESTIGATOR

  • Ann Cools, PhD

    University Ghent

    STUDY CHAIR

Central Study Contacts

Dominiek Vandenbosch, MSc

CONTACT

+32 9 332 16 69dominiek.vandenbosch@ugent.be

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

December 23, 2022

First Posted

January 26, 2023

Study Start

March 1, 2023

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

April 12, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)