OsteoarthritisNCT02911389
Home PT vs FORCE PT
A study testing Home PT via web-based platform, Home PT via paper manual and outpatient PT in people with Osteoarthritis, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
The purpose of this study is to determine if unsupervised, home rehabilitation delivered by a web-based platform or paper manual is a safe and effective alternative to outpatient physical therapy after total knee replacement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Home PT via web-based platform, Home PT via paper manual and outpatient PT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Any patient undergoing unilateral, primary TKA
Who cannot join
- Patients without access to the Internet
- Patients without access to outpatient PT
- Revision or conversion TKA
- Patients discharged to a rehabilitation unit or other form of respite care such as a skilled nursing facility, acute rehabilitation center, convalescent home, long-term care facility or nursing home.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Rothman Institute
Philadelphia, Pennsylvania, 19148
Tiffany Morrison, MS, CCRP, 267-339-7818, tiffany.morrison@rothmaninstitute.com
About this study
Official title: Unsupervised Home Exercise With and Without a Web-based Recovery Platform as Compared to Traditional Outpatient Physiotherapy After Total Knee Arthroplasty: A Prospective, Randomized Controlled Trial
The purpose of this study is to determine if unsupervised, home rehabilitation delivered by a web-based platform or paper manual is a safe and effective alternative to outpatient physical therapy after total knee replacement.
- Conditions
- Osteoarthritis
- Being tested
- Home PT via web-based platform, Home PT via paper manual, outpatient PT
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home PT via web-based platformOther
Home PT via paper manualOther
outpatient PTOther
| Study group | Role | What they receive |
|---|---|---|
| Home PT via web-based platform | Active comparator | unsupervised, home rehabilitation delivered by a web-based platform Receives: Other: Home PT via web-based platform |
| Home PT via paper manual | Active comparator | unsupervised, home rehabilitation delivered by a paper manual Receives: Other: Home PT via paper manual |
| outpatient PT | Active comparator | outpatient physical therapy Receives: Other: outpatient PT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Range of Motion
Measured in degrees from 0-130
Measured: 1 month post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02911389
- Sponsor's protocol ID
- 16Chen01
- Status last verified
- Sep 2016
- First submitted
- 15 Sep 2016
- Last updated
- 22 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unsupervised Home Exercise With and Without a Web-based Recovery Platform as Compared to Traditional Outpatient Physiotherapy After Total Knee Arthroplasty: A Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02911389
- Acronym / sponsor ID
- 16Chen01
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2017 (estimated)
- First posted
- 22 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if unsupervised, home rehabilitation delivered by a web-based platform or paper manual is a safe and effective alternative to outpatient physical therapy after total knee replacement.
Study design
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Home PT via web-based platform | Active comparator | Other: Home PT via web-based platformunsupervised, home rehabilitation delivered by a web-based platform |
| Home PT via paper manual | Active comparator | Other: Home PT via paper manualunsupervised, home rehabilitation delivered by a paper manual |
| outpatient PT | Active comparator | Other: outpatient PToutpatient physical therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Any patient undergoing unilateral, primary TKA
Key exclusion criteria (4 listed)
- Patients without access to the Internet
- Patients without access to outpatient PT
- Revision or conversion TKA
- Patients discharged to a rehabilitation unit or other form of respite care such as a skilled nursing facility, acute rehabilitation center, convalescent home, long-term care facility or nursing home.
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 |
|---|---|---|
| Home PT via web-based platform | Other | Home PT via web-based platform |
| Home PT via paper manual | Other | Home PT via paper manual |
| outpatient PT | Other | outpatient PT |
Primary outcome
Knee Range of Motion
Time frame: 1 month post surgery
Measured in degrees from 0-130
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home PT via web-based platform, Home PT via paper manual and outpatient PT in people with Osteoarthritis, run by Rothman Institute Orthopaedics 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 1 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: status not confirmed, as of the sponsor's last update on 22 Sep 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Range of Motion (time frame: 1 month post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2016.