Community Based Rehabilitation Model After Total Knee Rep... | NCT06270446

Studies
Community Based Rehabilitation Model After Total Knee Replacement

NCT06270446

Sponsor

Tan Tock Seng Hospital

Status

Completed

Last Update Posted

Feb 21, 2024Actual

Enrollment

59Actual

Phase

Not Applicable

Conditions

Knee Osteoarthritis

Interventions

Community based physiotherapy
Outpatient physiotherapy

Countries

Singapore

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Actual

Primary Completion Date

Jul 1, 2022Actual

Completion Date

Jul 1, 2022Actual

First Submitted Date

Feb 14, 2024

First Submission Date that Met QC Criteria

Feb 14, 2024

First Posted Date

Feb 21, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2024

Last Update Posted Date

Feb 21, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To investigate the clinical efficacy of community-based early stage knee replacement rehabilitation program as compared with usual care in acute hospital outpatient clinic

Detailed Description

To investigate the clinical efficacy of community-based early stage knee replacement rehabilitation program as compared with usual care in acute hospital outpatient clinic

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

59Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Outpatient	Other	Usual care, outpatient physiotherapy	Other: Outpatient physiotherapy
CRC	Active Comparator	Community based physiotherapy	Other: Community based physiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Community based physiotherapy	Other	Physiotherapy at community rehabilitation center	CRC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
TUG	TUG score	3 months
30 sec chair stand test	30 sec chair stand test score	3 months
Pain intensity	Pain intensity score	3 months

Secondary Outcomes

Measure	Description	Time Frame
Knee flexion and extension	Knee flexion and extension ROM	3 months
Passive range of motion	Passive range of motion ROM	3 months

Other Outcomes

Measure	Description	Time Frame
OKS	Oxford knee score	3 months

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eng Chuan Neoh	Tan Tock Seng Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tan Tock Seng Hospital		Singapore			Singapore

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided