Physical TherapyNCT04843280
Traditional PT v Internet Based PT After Total Knee Arthroscopy
A study testing FORCE therapeutics (physical therapy) and Traditional Outpatient Physical Therapy in people with Physical Therapy, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
Knee arthroscopy results in significant improvements in functional outcomes, pain relief and quality of life for patients suffering from mechanical symptoms associated with meniscal tears. Patients are able to return to their activities of daily living, occupation, or sport without significant limitations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Therapy
- What is being tested?
- FORCE therapeutics (physical therapy) and Traditional Outpatient Physical Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2017to 19 Feb 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any patient undergoing unilateral primary knee arthroscopy for meniscal tear
- Any patient 18 years or older
Who cannot join
- Patients without access to the Internet
- Post-traumatic osteoarthritis
- Patients with ligamentous injury
- Patients with full thickness cartilage defects
- Patients with osteoarthritis or inflammatory arthritis
- Revision or conversion knee arthroscopy
- Patients receiving workers compensations
- 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
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: Comparison of Traditional Physical Therapy to Internet-Based Physical Therapy After Knee Arthroscopy: A Prospective Randomized Controlled Trial Comparing Patient Outcomes and Satisfaction
Knee arthroscopy results in significant improvements in functional outcomes, pain relief and quality of life for patients suffering from mechanical symptoms associated with meniscal tears. Patients are able to return to their activities of daily living, occupation, or sport without significant limitations. Traditionally, patients have undergone formal physical therapy (PT) after knee arthroscopy to regain function. There is a significant cost and time commitment associated with traditional outpatient physical therapy. An internet based therapy program allows patients to perform therapy at home on their own time schedule. A recent study demonstrated that patients who undergo internet based PT after total knee arthroplasty performed as well patients receiving traditional physical therapy. These findings have not been studied in the knee arthroscopy patient population. The goal of this study is to compare traditional outpatient physical therapy rehabilitation to Internet-based rehabilitation in patients undergoing knee arthroscopy for partial meniscectomy.
The purpose of this study is to compare functional outcome, and patient satisfaction, internet-based rehabilitation program vs. standard outpatient physical therapy after unilateral knee arthroscopy for meniscal tear.
- Conditions
- Physical Therapy
- Being tested
- FORCE therapeutics (physical therapy), Traditional Outpatient Physical Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FORCE therapeutics (physical therapy)Procedure or surgery
6 weeks of internet based physical therapy following arthroscopic knee surgery
Traditional Outpatient Physical TherapyProcedure or surgery
6 weeks of outpatient physical therapy following arthroscopic knee surgery
| Study group | Role | What they receive |
|---|---|---|
| Traditional Physical Therapy | Active comparator | Participants who have undergone primary unilateral knee arthroscopy will undergo 6 weeks of formal outpatient physical therapy Receives: Procedure: Traditional Outpatient Physical Therapy |
| Internet Based Physical Therapy | Active comparator | Participants who have undergone primary unilateral knee arthroscopy will undergo 6 weeks of internet based rehabilitation regime in the home through the online recovery program, FORCE Therapeutics Receives: Procedure: FORCE therapeutics (physical therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Knee Function
Investigators will be measuring whether there is an increase in participants function as assessed by the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation. This will be measured on a scale of 0-100 with 0 being the lowest level of function and 100 being the highest level of function
Measured: 4 months
Cost analysis
cost analysis survey will be completed by participants to determine if there is a difference in outpatient physical therapy versus internet based physical therapy
Measured: 4 months
Postoperative Physical therapy Patient Satisfaction
Participant satisfaction with physical therapy will be assessed using the physical therapy satisfaction evaluation. This consist of a single question asking the participant how satisfied they are with their surgery on a scale of 0-10. 0 being not satisfied at all and 10 being extremely satisfied.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start30 Jul 2017
- Primary completion19 Feb 2019
- Study completion19 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical TherapyStudies 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
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04843280
- Sponsor's protocol ID
- DMAZ17D.288
- Status last verified
- Apr 2021
- First submitted
- 31 Mar 2021
- Last updated
- 13 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Traditional Physical Therapy to Internet-Based Physical Therapy After Knee Arthroscopy: A Prospective Randomized Controlled Trial Comparing Patient Outcomes and Satisfaction
- ClinicalTrials.gov ID
- NCT04843280
- Acronym / sponsor ID
- DMAZ17D.288
- Conditions
- Physical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 30 Jul 2017 (actual)
- Primary completion
- 19 Feb 2019 (actual)
- Study completion
- 19 Feb 2019 (actual)
- First posted
- 13 Apr 2021 (actual)
- 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.
Knee arthroscopy results in significant improvements in functional outcomes, pain relief and quality of life for patients suffering from mechanical symptoms associated with meniscal tears. Patients are able to return to their activities of daily living, occupation, or sport without significant limitations. Traditionally, patients have undergone formal physical therapy (PT) after knee arthroscopy to regain function. There is a significant cost and time commitment associated with traditional outpatient physical therapy. An internet based therapy program allows patients to perform therapy at home on their own time schedule. A recent study demonstrated that patients who undergo internet based PT after total knee arthroplasty performed as well patients receiving traditional physical therapy. These findings have not been studied in the knee arthroscopy patient population. The goal of this study is to compare traditional outpatient physical therapy rehabilitation to Internet-based rehabilitation in patients undergoing knee arthroscopy for partial meniscectomy.
The purpose of this study is to compare functional outcome, and patient satisfaction, internet-based rehabilitation program vs. standard outpatient physical therapy after unilateral knee arthroscopy for meniscal tear.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Physical Therapy | Active comparator | Procedure: Traditional Outpatient Physical TherapyParticipants who have undergone primary unilateral knee arthroscopy will undergo 6 weeks of formal outpatient physical therapy |
| Internet Based Physical Therapy | Active comparator | Procedure: FORCE therapeutics (physical therapy)Participants who have undergone primary unilateral knee arthroscopy will undergo 6 weeks of internet based rehabilitation regime in the home through the online recovery program, FORCE Therapeutics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Any patient undergoing unilateral primary knee arthroscopy for meniscal tear
- Any patient 18 years or older
Key exclusion criteria (8 listed)
- Patients without access to the Internet
- Post-traumatic osteoarthritis
- Patients with ligamentous injury
- Patients with full thickness cartilage defects
- Patients with osteoarthritis or inflammatory arthritis
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 |
|---|---|---|
| FORCE therapeutics (physical therapy)6 weeks of internet based physical therapy following arthroscopic knee surgery | Procedure or surgery | Internet Based Physical Therapy |
| Traditional Outpatient Physical Therapy6 weeks of outpatient physical therapy following arthroscopic knee surgery | Procedure or surgery | Traditional Physical Therapy |
Primary outcome
Postoperative Knee Function
Time frame: 4 months
Investigators will be measuring whether there is an increase in participants function as assessed by the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation. This will be measured on a scale of 0-100 with 0 being the lowest level of function and 100 being the highest level of function
Cost analysis
Time frame: 4 months
cost analysis survey will be completed by participants to determine if there is a difference in outpatient physical therapy versus internet based physical therapy
Postoperative Physical therapy Patient Satisfaction
Time frame: 4 months
Participant satisfaction with physical therapy will be assessed using the physical therapy satisfaction evaluation. This consist of a single question asking the participant how satisfied they are with their surgery on a scale of 0-10. 0 being not satisfied at all and 10 being extremely satisfied.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
Related trials for Physical Therapy
Not yet recruiting
Effects of Upper Extremity Physiotherapy and Home Exercises on Functional Outcomes in Individuals With Stroke
Stroke
Not yet recruiting
EFFECT OF ADDING BLOOD FLOW RESTRICTION TRAINING TO CLOSED CHAIN EXERCISE IN KNEE OSTEOARTHRITIS
Knee Osteoarthritis
Not yet recruiting
The Mechatronic Remote Physiotherapy System (MRPS) in Remote Stroke Rehabilitation
Stroke, Neurological Disorder
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Not yet recruiting
COG+OT Telerehabilitation for Adults With Subjective Cognitive Complaints
Subjective Cognitive Complaints, Ehlers-Danlos Syndrome
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 FORCE therapeutics (physical therapy) and Traditional Outpatient Physical Therapy in people with Physical Therapy, 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 2 inclusion and 8 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 13 Apr 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postoperative Knee Function (time frame: 4 months). The study lists 3 primary outcomes in all. 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 13 Apr 2021.