Total Knee ArthroplastyNCT02646761

interACTION: A Portable Joint Function Monitoring and Training System for Remote Rehabilitation Following TKA

A study testing InterACTION in people with Total Knee Arthroplasty, run by James J. Irrgang at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to determine if home-based therapy with monitoring via telemedicine can overcome many barriers to compliance and improve rehabilitation. Patients undergoing total knee arthroplasty will be followed for 10 weeks during their outpatient physical therapy course. Read more about this study

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Total Knee Arthroplasty
What is being tested?: InterACTION
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 1 siteUnited States
Study dates: Apr 2016to Dec 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Between ages 40 to 80 years of age;
Have undergone primary unilateral total knee arthroplasty;
Being referred for post-operative outpatient physical therapy;
Agree to and able to perform pre-defined exercises that they would normally perform in a physical rehabilitation program.

Who cannot join

Patients with BMI >40 at the time of surgery;
Individuals who are not free of any other co-disability or comorbidity that would specifically impede disallow or otherwise hinder performance of rehabilitation exercises;
Individuals who cannot physically receive or understand audio and visual feedback from the joint motion tracking system during or after performance of rehabilitation exercises;
Individuals who are discharged post-operatively to a skilled nursing facility instead of to their residence;

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pittsburgh
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: interACTION: A Portable Joint Function Monitoring and Training System for Remote Rehabilitation Following Total Knee Arthroplasty

Conditions: Total Knee Arthroplasty
Being tested: InterACTION, Standard of Care Physical Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

InterACTIONDevice
InterACTION guided home exercise program paired with standard of care physical therapy
Standard of Care Physical TherapyOther
Physical therapy rehabilitation program

Study groups in NCT02646761
Study group	Role	What they receive
Rehabilitation with InterACTION	Experimental	After total knee arthroplasty, subjects will undergo physical therapy 1 time per week supplemented by home exercise program with InterACTION device. Receives: Device: InterACTION
Standard Physical Therapy	Other	After total knee arthroplasty, subjects will undergo standard of care physical therapy 2 times per week with standard home exercise program. Receives: Other: Standard of Care Physical Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Value Was Evaluated as the Ratio of Change in the Activities of Daily Living Scale Score to the Costs of Rehabilitation.
The value was calculated the ratio of the difference between the 10 week and baseline Activities of Daily Living Scale (ADLS) of the Knee Outcome Survey divided by the total charges for the physical therapy treatment sessions. The ADLS is a 14-item measure of symptoms and activity limitations for individuals with a variety of knee impairments. Items are scored from 0 to 4, and the total score is the sum of all the items divided by 70 and multiplied by 100. The ADLS score ranges from 0 to 100 with higher scores representing less symptoms and greater levels of activity. Higher ratio of the change in the ADLS score to the costs for rehabilitation represents greater value.
Measured: 10 weeks

Secondary outcomes (5)

Number of Participants That Complied With Rehabilitation Program
Compliance with the use of the InterACTION device was measured by reports generated from the device. Subjects in the Standard Physical Therapy Group completed exercise logs that were monitored at each study visit.
Measured: 10 weeks
Number of Subjects Satisfied With InterACTION Device
Subjects in the interACTION group were asked "Would you consider using the InterACTION device if you had to do rehabilitation again in the future?"
Measured: 10 weeks
Performance Based Outcome Measures
The performance based measures included the 6-minute walk test (measured as distance in meters); stair climb test (measured as time in seconds divided by the number of steps); timed up and go test (measured in seconds); and unilateral balance test (measured in seconds). To combine the 4 performance-based outcome measures into a single composite score, the score for each test was converted to a z score (individual's score - overall mean)/overall standard deviation. As such, the z-score represents the number of SD deviations an individual's score is above or below the overall study mean. A z-score of 0 implies the participants score is the same as the mean score. A z-score of 0.1 would indicate that the participant's z score is .1 (10%) of a standard deviation above or below the overall mean. The average of the z scores for each performance-based outcome measure as the unit of analysis.
Measured: 10 weeks
Range of Motion (Extension)
Extension of both knees was measured with a goniometer and the side-to-side difference was expressed in degrees.
Measured: baseline and 10 weeks
Range of Motion (Flexion)
Flexion of both knees was measured with a goniometer and the side-to-side difference was expressed in degrees.
Measured: baseline and 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2016Dec 2017

First posted6 Jan 2016 (estimated)
Study startApr 2016
Primary completionDec 2017
Study completionDec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02646761
Sponsor's protocol ID: PRO15060281
Status last verified: Jan 2019
First submitted: 14 Aug 2015
Last updated: 5 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Bell KM, Onyeukwu C, Smith CN, Oh A, Devito Dabbs A, Piva SR, Popchak AJ, Lynch AD, Irrgang JJ, McClincy MP. A Portable System for Remote Rehabilitation Following a Total Knee Replacement: A Pilot Randomized Controlled Clinical Study. Sensors (Basel). 2020 Oct 27;20(21):6118. doi: 10.3390/s20216118.
PubMed 33121204

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Not yet recruiting
Total Hip Replacement: an Investigation of Robotic-assisted Versus conVentional Surgery and Patient-centred outcomEs
Osteo Arthritis Knee and Hip
Recruiting
Radiofrequency Ablation for the Treatment of Post-knee Arthroplasty Chronic Pain.
Chronic Post-surgical Pain, Chronic Post Operative Pain
Not yet recruiting
Effects of Different Bispectral Index Target Depths on Early Postoperative Recovery Quality in Elderly Patients Undergoing Total Knee Arthroplasty
Total Knee Arthroplasty, Postoperative Recovery
Enrolling by invitation
Early Outcome of Simultaneous Bilateral Total Knee Replacement With and Without Tourniquet
Arthroplasty, Replacement, Knee, Blood Loss, Surgical

All Total Knee Arthroplasty trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: interACTION: A Portable Joint Function Monitoring and Training System for Remote Rehabilitation Following Total Knee Arthroplasty
ClinicalTrials.gov ID: NCT02646761
Acronym / sponsor ID: PRO15060281
Conditions: Total Knee Arthroplasty
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: James J. IrrgangUniversity, hospital or other
Study start: Apr 2016
Primary completion: Dec 2017 (actual)
Study completion: Dec 2017 (actual)
First posted: 6 Jan 2016 (estimated)
Results: Posted 5 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Rehabilitation with InterACTION	Experimental	Device: InterACTIONAfter total knee arthroplasty, subjects will undergo physical therapy 1 time per week supplemented by home exercise program with InterACTION device.
Standard Physical Therapy	Other	Other: Standard of Care Physical TherapyAfter total knee arthroplasty, subjects will undergo standard of care physical therapy 2 times per week with standard home exercise program.

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Between ages 40 to 80 years of age;
Have undergone primary unilateral total knee arthroplasty;
Being referred for post-operative outpatient physical therapy;
Agree to and able to perform pre-defined exercises that they would normally perform in a physical rehabilitation program.

Key exclusion criteria (4 listed)

Patients with BMI >40 at the time of surgery;
Individuals who are not free of any other co-disability or comorbidity that would specifically impede disallow or otherwise hinder performance of rehabilitation exercises;
Individuals who cannot physically receive or understand audio and visual feedback from the joint motion tracking system during or after performance of rehabilitation exercises;
Individuals who are discharged post-operatively to a skilled nursing facility instead of to their residence;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
InterACTIONInterACTION guided home exercise program paired with standard of care physical therapy	Device	Rehabilitation with InterACTION
Standard of Care Physical TherapyPhysical therapy rehabilitation program	Other	Standard Physical Therapy

Primary outcome

Value Was Evaluated as the Ratio of Change in the Activities of Daily Living Scale Score to the Costs of Rehabilitation.
Time frame: 10 weeks
The value was calculated the ratio of the difference between the 10 week and baseline Activities of Daily Living Scale (ADLS) of the Knee Outcome Survey divided by the total charges for the physical therapy treatment sessions. The ADLS is a 14-item measure of symptoms and activity limitations for individuals with a variety of knee impairments. Items are scored from 0 to 4, and the total score is the sum of all the items divided by 70 and multiplied by 100. The ADLS score ranges from 0 to 100 with higher scores representing less symptoms and greater levels of activity. Higher ratio of the change in the ADLS score to the costs for rehabilitation represents greater value.

5 secondary outcomes

Number of Participants That Complied With Rehabilitation Program
Time frame: 10 weeks
Number of Subjects Satisfied With InterACTION Device
Time frame: 10 weeks
Performance Based Outcome Measures
Time frame: 10 weeks
Range of Motion (Extension)
Time frame: baseline and 10 weeks
Range of Motion (Flexion)
Time frame: baseline and 10 weeks

Results and safety

Results posted to the registry on 5 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Rehabilitation With InterACTION	18	10
Standard Physical Therapy	20	10

Primary outcome: Value Was Evaluated as the Ratio of Change in the Activities of Daily Living Scale Score to the Costs of Rehabilitation.

Time frame: 10 weeks. Mean (Standard Deviation). Unit: ratio

Measure	Rehabilitation With InterACTION n = 10	Standard Physical Therapy n = 10
Value	0.013 (0.007)	0.018 (0.009)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were monitored from the start of the intervention until 10 weeks follow-up.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rehabilitation With InterACTION	0 of 13 (0%)	0 of 13 (0%)	0 of 13
Standard Physical Therapy	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33121204Bell KM, Onyeukwu C, Smith CN, Oh A, Devito Dabbs A, Piva SR, Popchak AJ, Lynch AD, Irrgang JJ, McClincy MP. A Portable System for Remote Rehabilitation Following a Total Knee Replacement: A Pilot Randomized Controlled Clinical Study. Sensors (Basel). 2020 Oct 27;20(21):6118. doi: 10.3390/s20216118.

Related trials for Total Knee Arthroplasty

Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Not yet recruiting
Total Hip Replacement: an Investigation of Robotic-assisted Versus conVentional Surgery and Patient-centred outcomEs
Osteo Arthritis Knee and Hip
Recruiting
Radiofrequency Ablation for the Treatment of Post-knee Arthroplasty Chronic Pain.
Chronic Post-surgical Pain, Chronic Post Operative Pain
Not yet recruiting
Effects of Different Bispectral Index Target Depths on Early Postoperative Recovery Quality in Elderly Patients Undergoing Total Knee Arthroplasty
Total Knee Arthroplasty, Postoperative Recovery
Enrolling by invitation
Early Outcome of Simultaneous Bilateral Total Knee Replacement With and Without Tourniquet
Arthroplasty, Replacement, Knee, Blood Loss, Surgical

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing InterACTION in people with Total Knee Arthroplasty, run by James J. Irrgang at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Value Was Evaluated as the Ratio of Change in the Activities of Daily Living Scale Score to the Costs of Rehabilitation. (time frame: 10 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02646761, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2019.