NCT07834229

Brief Summary

The goal of this clinical trial is to determine if rehabilitation delivered by telehealth works as well as rehabilitation delivered in person at a clinic, for people recovering from total knee replacement surgery. The main question it aims to answer is:

  • Does rehabilitation by video call lead to knee-related quality of life that is just as good as rehabilitation completed in person at a clinic? Researchers will compare a telehealth group to a clinic group to see if telehealth rehabilitation works as well as in-person rehabilitation. Participants will:
  • Take part in 9 rehabilitation sessions over 6 weeks, either by video call from home or in person at a clinic
  • Follow a home exercise program using an online app
  • Answer questions about their knee and daily activities before surgery, and again at 7 weeks, 6 months, and 12 months after surgery
  • Have their knee movement and physical abilities, such as walking speed and climbing stairs, measured by a therapist before surgery, and again at 7 weeks, and 12 months after surgery

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

September 16, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 22, 2026

Completed
Last Updated

September 22, 2026

Status Verified

August 1, 2026

Enrollment Period

2 years

First QC Date

August 31, 2026

Last Update Submit

September 15, 2026

Conditions

Keywords

Total Knee ArthroplastyTKATelehealth

Outcome Measures

Primary Outcomes (1)

  • Knee-Related Quality of Life (QOL) subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS)

    KOOS-QOL is a 4-item subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS) that assesses knee-related quality of life. Scores range from 0 to 100, where 0 indicates extreme knee-related problems and 100 indicates no knee-related problems. Higher scores indicate better knee-related quality of life.

    Pre-operative, 7 weeks post-surgery, 6 months post-surgery, and 12 months post-surgery

Secondary Outcomes (16)

  • Pain subscale (KOOS-PAIN) of the Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Pre-operative, 7 weeks post-surgery, 6 months post-surgery, and 12 months post-surgery

  • Symptom subscale (KOOS-SYMPTOM) of the Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Pre-operative, 7 weeks post-surgery, 6 months post-surgery, and 12 months post-surgery

  • Activity of Daily Living (KOOS-ADLs) subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Pre-operative, 7 weeks post-surgery, 6 months post-surgery, and 12 months post-surgery

  • Sport and Recreation subscale (KOOS-Sport and Recreation) of the Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Pre-operative, 7 weeks post-surgery, 6 months post-surgery, and 12 months post-surgery

  • Active knee flexion range of movement (ROM)

    Pre-operative, 7 weeks post-surgery, and 12 months post-surgery

  • +11 more secondary outcomes

Study Arms (2)

Telerehabilitation Group

EXPERIMENTAL

Treatment sessions were delivered and supervised remotely using telerehabilitation technology.

Behavioral: Rehabilitation treatment sessions focussing on education and exercise prescription.

Clinic Group

ACTIVE COMPARATOR

Treatment sessions were delivered in-person at a single private rehabilitation clinic.

Behavioral: Rehabilitation treatment sessions focussing on education and exercise prescription.

Interventions

Both arms of the study received an identical rehabilitation protocol comprising nine supervised sessions delivered over a 6-week post-operative period (twice weekly for the first three weeks, followed by once weekly for a further three weeks), commencing 4-7 days after surgery. Each session lasted approximately 30 minutes and was delivered by Accredited Exercise Physiologists. Both groups were provided Home Exercise Programs (HEP) via an online platform.

Clinic GroupTelerehabilitation Group

Eligibility Criteria

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

You may qualify if:

  • undergoing primary elective TKA for the treatment of end stage knee OA
  • ability to independently provide informed consent
  • a willingness to attend all rehabilitation sessions and assessment time points, irrespective of the delivery

You may not qualify if:

  • comorbidities preventing participation in rehabilitation (e.g., severe obstructive pulmonary disease, hemiplegia)
  • revision TKA
  • intra-operative complications precluding rehabilitation
  • likely difficulties with follow-up
  • inability to read or speak English
  • unable to attend in person clinic visits due to travel distance
  • unwillingness to comply with the rehabilitation protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HFRC Rehabilitation Clinic

Perth, Western Austrlaia, 6009, Australia

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

August 31, 2026

First Posted

September 22, 2026

Study Start

September 16, 2020

Primary Completion

August 31, 2022

Study Completion

August 31, 2022

Last Updated

September 22, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations