NCT03476148

Brief Summary

Rehabilitation after total knee arthroplasty is very important in terms of range of motion of the knee, muscle power, normal gait, pain control and consequently the patient's satisfaction. Convectional rehabilitation methods in assist of therapist required high demand of resources. Recently, outpatient clinic or tele-communication tool based rehabilitations were investigated and reported equivalent results. However, those methods also required group or one-to-one facing that restricted availability of the exercise. With development of the motion tracking technology, new device that gives real time feedback with augmented reality images can be used for rehabilitation in home-based setting. This study aims to compare the clinical outcomes after the rehabilitation by interactive home-based device or conventional inpatient setting.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

March 13, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

March 22, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 23, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2020

Completed
Last Updated

March 23, 2018

Status Verified

March 1, 2018

Enrollment Period

9 months

First QC Date

March 13, 2018

Last Update Submit

March 18, 2018

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change in Western Ontario and McMaster Universities Index(WOMAC index)

    preoperative, postoperative at 6, 12 weeks

  • Change in Knee Society Score

    preoperative, postoperative at 6, 12 weeks

  • Change in Time-Up-Go (TUG) test

    preoperative, postoperative at 6, 12 weeks

Study Arms (2)

Interactive Device Rehabilitation

EXPERIMENTAL
Device: Home Rehabilitation using Interactive device

Inpatient Rehabilitation

ACTIVE COMPARATOR
Other: Inpatient Rehabilitation

Interventions

Rehabilitation is performed using interactive motion tracking augmented reality device. 6 exercises are included in one-day rehabilitation program. Each exercise is recorded in aspect of compliance, completion.

Interactive Device Rehabilitation

Patients are given the exercises in the setting of inpatient rehabilitation

Inpatient Rehabilitation

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • over 19 year old
  • Patients for total knee arthroplasty of one knee
  • Patients who can understand and utilize the device

You may not qualify if:

  • who don't agree with participation of the study
  • who can not understand and utilize the device
  • Rheumatoid arthritis, Other inflammatory arthritis
  • Neuropsychiatric patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 13, 2018

First Posted

March 23, 2018

Study Start

March 22, 2018

Primary Completion

December 31, 2018

Study Completion

March 21, 2020

Last Updated

March 23, 2018

Record last verified: 2018-03