NCT07539948

Brief Summary

Problem: Total knee replacement (TKR) surgeries are increasing due to ageing populations. Current rehabilitation has a gap - patients do unsupervised exercises at home for 2-3 weeks between hospital discharge and outpatient appointments, leading to poor compliance and complications. Current Issues: 25% of patients don't achieve meaningful functional improvement for 6+ months, and 20% still have significant limitations after 2 years. Proposed Solution: Deploy a robot-aided device for intensive, self-paced home rehabilitation exercises to help patients return to near-normal function within 1 month. Goals: Improve early functional recovery, increase exercise compliance, reduce costs, and enhance long-term quality of life for knee osteoarthritis patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable knee-osteoarthritis

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

April 23, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2026

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 20, 2026

Completed
Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

March 26, 2026

Last Update Submit

April 13, 2026

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Mean change in quadricep strength from baseline to 1 month (unit: KgF)

    Mean change in quadriceps strength from baseline to 1 month using the dynamometer. There is no minimum or maximum value for quadriceps strength as it differs from person to person. A higher score mean a better outcome.

    1 month

Secondary Outcomes (2)

  • Mean Change in Oxford Knee Score from Baseline to 1 Month

    1 month

  • Mean Change in Knee Society Score from Baseline to 1 Month

    1 month

Study Arms (1)

Knee Locobot

EXPERIMENTAL

Participant receive 4 weekly knee locobot training on the affected leg

Device: Knee Locobot

Interventions

Knee LocobotDEVICE

During the session, participants will use the Knee-LOCOBOT machine for 45 minutes in clinic (including 5-10 mins of warm up and cool down).

Knee Locobot

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 21-80 years old,
  • Diagnosed to have knee osteoarthritis by clinician
  • Ability to understand and give consent
  • Premorbid Functional Ambulation Category of 6
  • Knee flexion ROM of at least 100 degrees
  • Ability to sit continuously for 60 minutes

You may not qualify if:

  • Presence of co-existing neurological impairments causing lower limb weakness (e.g. stroke)
  • Medical conditions incompatible with research participation: uncontrolled medical illnesses (hypertension or diabetes, ischaemic heart disease, congestive heart failure, bronchial asthma, severe /untreated depression, agitation, end stage renal/liver/heart/lung failure, unresolved cancers.
  • Anticipated life expectancy of \< 6 months
  • Local factors potentially worsened by intensive robot-aided arm therapy and computer-based training: recent limb fracture, knee pain VAS \>4/10, fixed knee flexion contracture \>10-degree, keen flexion range of motion \<100 degree
  • Any musculoskeletal condition that may limit continuous exercise duration of 30minutes
  • Pregnant women
  • Recent knee operation within past 3 month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tan Tock Seng Hospital

Singapore, Singapore

Location

Related Publications (3)

  • Mizner RL, Petterson SC, Stevens JE, Vandenborne K, Snyder-Mackler L. Early quadriceps strength loss after total knee arthroplasty. The contributions of muscle atrophy and failure of voluntary muscle activation. J Bone Joint Surg Am. 2005 May;87(5):1047-53. doi: 10.2106/JBJS.D.01992.

    PMID: 15866968BACKGROUND

  • Singh JA, O'Byrne M, Harmsen S, Lewallen D. Predictors of moderate-severe functional limitation after primary Total Knee Arthroplasty (TKA): 4701 TKAs at 2-years and 2935 TKAs at 5-years. Osteoarthritis Cartilage. 2010 Apr;18(4):515-21. doi: 10.1016/j.joca.2009.12.001. Epub 2009 Dec 21.

    PMID: 20060950BACKGROUND

  • Bade MJ, Stevens-Lapsley JE. Early high-intensity rehabilitation following total knee arthroplasty improves outcomes. J Orthop Sports Phys Ther. 2011 Dec;41(12):932-41. doi: 10.2519/jospt.2011.3734. Epub 2011 Sep 30.

    PMID: 21979411BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Ong Poo Lee

Study Record Dates

First Submitted

March 26, 2026

First Posted

April 20, 2026

Study Start

April 23, 2025

Primary Completion

August 19, 2025

Study Completion

August 19, 2025

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)