Accelerated Rehabilitation in Individuals After Total Knee Arthroplasty

December 21, 2025 updated by: Mahidol University

Effectiveness of Accelerated Rehabilitation on Knee Joint Function and Quality of Life in Individuals With Total Knee Arthroplasty: A Double Blind Randomized Controlled Trial

The primary aim of this double-blind randomized controlled trial is to evaluate the effectiveness of an accelerated rehabilitation protocol on knee joint function and quality of life in individuals undergoing TKA compared to conventional rehabilitation in Dali, Yunan, China. The study will include patients aged 50-80 years who are scheduled for primary unilateral TKA. Participants will be randomly assigned to either an accelerated rehabilitation group or conventional rehabilitation group. The primary outcomes will include knee joint function, assessed using the KOOS and quality of life measures using the SF-36 surveys. The study will follow participants for 6 months post-surgery to assess longer-term outcomes. This study will not include individuals undergoing revision TKA or those with severe comorbid conditions. The results will provide critical insights into the role of accelerated rehabilitation in improving post-operative recovery, functional outcomes, and overall quality of life for TKA patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients diagnosed with end-stage knee OA necessitating primary unilateral TKA.

Exclusion Criteria:

  • History of joint infections, cancer, or inflammatory arthritis.
  • End-stage OA from rheumatoid or septic arthritis.
  • Individuals with neurological disorders such as Alzheimer's disease, - Parkinson's disease, stroke.
  • Individuals who are unable to follow a structured rehabilitation protocol.
  • Previous history of knee surgeries (other than arthroscopy).
  • Severe comorbidities that would hinder participation (e.g., advanced cardiovascular diseases).
  • Individuals who have severe osteoporosis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional rehabilitation
Behavioral: Routine exercise
Conventional program
Experimental: Accelerated rehabilitation
Rehabilitaion after TKR with the accelerated and optimal loading concepts
Behavioral: Accelerated exercise
Based on optimal and accelerated concepts

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: From enrollment to the end of 6-month follow-up
From enrollment to the end of 6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Study Chair: Komsak Sinsurin, Ph.D., DPT, Mahidol University
  • Principal Investigator: Liying Yang, West Yunnan University of Applied Sciences, Yunnan province

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

December 21, 2025

First Submitted That Met QC Criteria

December 21, 2025

First Posted (Actual)

January 6, 2026

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

December 21, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • MU-CIRB 2025/443.2908

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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