- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06270446
Community Based Rehabilitation Model After Total Knee Replacement
Community Based Rehabilitation Model After Total Knee Replacement: A Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Singapore, Singapore
- Tan Tock Seng Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
i) unilateral TKA; ii) age 55 years old and above; iii) able to engage in outpatient physiotherapy; iii) postoperative knee flexion ≥75° and knee extension ≤5°; iv) able to ambulate independently preoperatively.
Exclusion Criteria:
i) had revision TKA or fully constrained knee arthroplasty; ii) had knee replacement for indications other than osteoarthritis; iii) had post-operative complications during hospital stay; iv) were unable to participate due to cognitive impairment or language barriers; v) had acute spinal diseases or joint, muscle or systemic diseases affecting gait; iv) had comorbid health conditions that would prevent active participation (e.g. prior hemiplegic stroke, severe cardiorespiratory illnesses.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Outpatient
Usual care, outpatient physiotherapy
|
Physiotherapy at hospital
|
|
Active Comparator: CRC
Community based physiotherapy
|
Physiotherapy at community rehabilitation center
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
TUG
Time Frame: 3 months
|
TUG score
|
3 months
|
|
30 sec chair stand test
Time Frame: 3 months
|
30 sec chair stand test score
|
3 months
|
|
Pain intensity
Time Frame: 3 months
|
Pain intensity score
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knee flexion and extension
Time Frame: 3 months
|
Knee flexion and extension ROM
|
3 months
|
|
Passive range of motion
Time Frame: 3 months
|
Passive range of motion ROM
|
3 months
|
|
Presence of lag
Time Frame: 3 months
|
Presence of knee extensor lag
|
3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
OKS
Time Frame: 3 months
|
Oxford knee score
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eng Chuan Neoh, Tan Tock Seng Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DSRB 2019/01135
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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