Patients Receiving Physical TherapyNCT04245852
Does a Video-based Education Tool Related to Strengthening Result in Different Functional Outcomes Compared to Traditional Physical Therapy Education for Patients?
A study testing Strength education video and standard PT care in people with Patients Receiving Physical Therapy, run by University of Illinois Chicago at 1 site in United States.
Trial summary
Patients receiving physical therapy (PT) at the University of Illinois at Chicago Faculty Practice (UICFP) meeting inclusion and exclusion criteria will be randomly assigned to one of two groups: control group (CG) receiving standard care and an experimental group (EG) receiving standard care in addition to being… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Receiving Physical Therapy
- What is being tested?
- Strength education video and standard PT care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2020to 16 Nov 2020
- 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
- Patients receiving physical therapy at the University of Illinois at Chicago Faculty Practice
- Strength training is a component of the intervention plan for physical therapy
- Strength training is being defined as any exercise aimed at improving the force production, speed, and ability of a muscle group or group of muscles by using body weight, resistance bands/cords, free weights, medicine balls, weight machines or similar equipment.
- Patient consents to be part of the study prior to leaving from 3rd physical therapy (PT) clinic visit (Eval +2 sessions)
- Age 18 or older
- Has been provided a PSFS on date of initial PT evaluation
Who cannot join
- Medical History of:
- Cancer, Fibromyalgia, Polymyositis, muscular dystrophy, Lupus, Multiple Sclerosis, Parkinson's, or any other progressive/degenerative muscle/nervous system condition, Rheumatoid arthritis
- Cognitive/psychological disorder limiting ability to comprehend educational video
- Dementia etc.
- English not preferred language
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago Physical Therapy Faculty Practice
Chicago, Illinois, 60608
About this study
- Patients receiving physical therapy (PT) at the University of Illinois at Chicago Faculty Practice (UICFP) meeting inclusion and exclusion criteria will be randomly assigned to one of two groups: control group (CG) receiving standard care and an experimental group (EG) receiving standard care in addition to being provided a strength education video (SEV). The SEV is a short video designed to provide instructions clarifying how to do strength-based exercises by monitoring a fatigue response with a set of any exercise. The EG will watch the video with headphones in the waiting room of the UICFP on an iPad. The EG will also be provided a handout with a link and QR code to the video on YouTube.com. Functional changes with PT will be tracked for both groups using a Patient Specific Functional Scale (PSFS) questionnaire at initial evaluation, follow up at session 3 or 4, and at any date of anticipated discharge. Basic demographic data (age, sex), dates of data collection, and any discharge dates will be tracked as well. If questions arise regarding the content of the SEV then the treating physical therapist will be permitted to answer and apply the content at their discretion. All therapists will have pre-approved the content of the video to ensure there are no contradictions to their usual methods of care. Data will be gathered for up to 3 months.
Read the detailed description
- Human subjects for the study will be recruited and participate in the study at the University of Illinois at Chicago Faculty Practice (UICFP) located at 1640 West Roosevelt Road, 3rd floor, Chicago IL. All of the treating physical therapists with the exception of Daniel Robinson will be participating as treating physical therapists in this study and will therefore be aware of the proceedings involved. The treating physical therapists: Aaron Keil, Brian Baranyi, Justin Payette, Deborah Davey, Benjamin Land, Richelle Caya, Amanda Montbriand, Adam Wielechowski will be screening and obtaining informed consent from study participants. Additionally, Jessica Pop will be assisting in data collection and organization of data for the study.
- Patients receiving physical therapy (PT) at the UICFP will be screened for eligibility according to inclusion and exclusion criteria by treating physical therapists including obtaining consent to participate in the study at date of initial physical therapy evaluation or before the patient leaves from the second follow up visit.
- Checking for inclusion and exclusion criteria will be referenced by the treating therapist from the "Patient Checklist Data Form" (PCDF)
- If a patient does not meet any of the inclusion criteria or meets one of the exclusion criteria they will be excluded from the study.
- If a patient is being added in the above manner on a date past initial evaluation the physical therapist must record previous data needed that is available from patient records (date of evaluation, Patient Specific Functional Scale (PSFS) average score). The PSFS will be provided to all possible candidates in the clinic as part of the standard intake paperwork. Therefore, the PSFS should still be available for data after obtaining consent.
- Upon passing exclusion and inclusion criteria and obtaining informed consent, patients will be randomized into either the control or experimental group. Only after these setup steps will the PCDF be filled out and, if appropriate, provide the Strength Education Video (SEV) for viewing.
- Once included into the study subjects will be randomly assigned to one of two groups: control group (CG) or experimental group (EG).
- CG will receive standard PT care
- EG will receive standard care in addition to being provided a SEV.
- The SEV must be watched by the patient at the UICFP prior to leaving from the 3rd PT visit.
- The EG will watch the video in the waiting room or other quiet available rooms on the 3rd floor within the UICFP.
- The video will be watched from an iPad/tablet/laptop/desktop computer device as available in the clinic.
- The EG will also be provided a handout with a link and QR code to the video on YouTube.com and disclaimer from the consent form.
- Disclaimer quoted from consent form: "Please follow the link bellow to the video hosted on YouTube.com. Please be aware that by viewing the video on YouTube.com you are agreeing to YouTube and Google's terms and conditions. This will not be sharing any of your protected health information held by the University of Illinois Hospital system or the University of Illinois at Chicago. You are not obligated to click on or view this link. It is intended as a helpful tool for your benefit. Please reach out to your treating physical therapist with any questions or concerns"
- Treating physical therapist will record the date of SEV viewing on the PCDF. - The PCDF will be used to record patient information by the treating physical therapist and have a study subject identification (ID) number added by either Daniel Robinson or Jessica Pop when performing data entry described later in protocol.
- Subject information contained in the PCDF includes:
- Treating Physical Therapist
- Patient Name
- Medical Record Number
- Age
- Sex
- Subject ID code
- Which group subject is allocated to (Control or experimental)
- Inclusion criteria checklist
- Exclusion criteria checklist
- Date of evaluation
- Evaluation PSFS score
- Date of SEV viewing (if in EG)
- Session number of SEV viewing (if in EG)
- Follow up PSFS score
- Follow up session number
- Follow up date
- Discharge PSFS score
- Discharge session number
- Discharge date
- Secondary Discharge PSFS score
- Secondary Discharge Session number
- Secondary Discharge date
- Tertiary Discharge PSFS score
- Tertiary Discharge Session number
- Tertiary Discharge date
- Indication if patient was discharged early from PT or had an unplanned discharge from PT.
- PCDF sheets will be kept with physical therapists when being used to gather data or in the UICFP in a locked cabinet/drawer in the folder of the specific physical therapist separate from standard treatment notes.
- Data from the PCDF will be entered without patient names into a Private Data Excel Sheet (PDES). This spreadsheet will be kept in a Box Health Data Folder (BHDF) only available to the study investigators (Daniel Robinson, Jessica Pop, and Brian Baranyi) using a secure password containing at least: one uppercase letter, one lower case letter, one number, one symbol, and at least 8 characters.
- Functional changes with PT will be tracked for both groups using a Patient Specific Functional Scale (PSFS) questionnaire at initial evaluation, follow up at session 3 or 4 (evaluation not counting as a session), and at any date of anticipated discharge.
- The PSFS being utilized has been altered slightly from its original form for the purpose of clarifying to patients that 10 is a high functional performance skill. This is being done due to subjective reports from clinicians that patients commonly misread the questionnaire selecting 10 as a score of low function based on pain being the common question they receive. The changes made do not involve adding any new words or content changes that would be expected to alter nature of answers.
- If questions arise regarding the content of the SEV then the treating physical therapist will be permitted to answer and apply the content at their discretion. All therapists will have pre-approved the content of the video to ensure there are no contradictions to their usual methods of care. Data will be gathered for up to 3 months.
- Conditions
- Patients Receiving Physical Therapy
- Being tested
- Strength education video, standard PT care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength education videoOther
The Strength education video must be watched by the patient at the University of Illinois at Chicago Faculty Practice (UICFP) prior to leaving from the 3rd physical therapy visit. The Experimental Group (EG) will watch the video in the waiting room or other quiet available rooms on the 3rd floor within the UICFP. The video will be watched from an iPad/tablet/laptop/desktop computer device as available in the clinic. The EG will also be provided a handout with a link and quick response code to the video on YouTube.com
standard PT careOther
standard PT care
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Experimental group will receive standard physical therapy care in addition to being provided a strength education video. Receives: Other: Strength education video; Other: standard PT care |
| Control Group | Active comparator | The control group will receive standard physical therapy care at the University of Illinois at Chicago Faculty Practice. Receives: Other: standard PT care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Specific Functional Scale
The Patient Specific Functional Scale (PSFS) is a clinical outcome tool that was designed and validated for the purpose of tracking changes in function for patients with a wide variety of clinical conditions. This is measuring up to three patient identified important activities which are each scored on a 0 to 10 scale. On this scale 0 indicates "unable to perform activity" and 10 indicates "able to perform activity"
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start11 Feb 2020
- Primary completion16 Nov 2020
- Study completion16 Nov 2020
Why it stopped: COVID pandemic disrupted subject recruitment and primary investigator no longer with our university; no additional interest in continuing the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Receiving Physical TherapyStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- 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
- Model description
- Subjects will be randomly assigned to one of two groups: control group or experimental group. The control group will receive standard PT care and the experimental group will receive standard physical therapy care in addition to being provided a strength education video.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Thomas Baranyi, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04245852
- Sponsor's protocol ID
- 2020-0007
- Status last verified
- Dec 2020
- First submitted
- 27 Jan 2020
- Last updated
- 7 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data. Data from this study will be compiled for research purposes but not singling out any specific participant or any participant personal identifiers (i.e. name date of birth, etc).
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Video-based Education Tool Related to Strengthening Result in Different Functional Outcomes Compared to Traditional Physical Therapy Education for Patients?
- ClinicalTrials.gov ID
- NCT04245852
- Acronym / sponsor ID
- 2020-0007
- Conditions
- Patients Receiving Physical Therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID pandemic disrupted subject recruitment and primary investigator no longer with our university; no additional interest in continuing the study.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 11 Feb 2020 (actual)
- Primary completion
- 16 Nov 2020 (actual)
- Study completion
- 16 Nov 2020 (actual)
- First posted
- 29 Jan 2020 (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.
- Patients receiving physical therapy (PT) at the University of Illinois at Chicago Faculty Practice (UICFP) meeting inclusion and exclusion criteria will be randomly assigned to one of two groups: control group (CG) receiving standard care and an experimental group (EG) receiving standard care in addition to being provided a strength education video (SEV). The SEV is a short video designed to provide instructions clarifying how to do strength-based exercises by monitoring a fatigue response with a set of any exercise. The EG will watch the video with headphones in the waiting room of the UICFP on an iPad. The EG will also be provided a handout with a link and QR code to the video on YouTube.com. Functional changes with PT will be tracked for both groups using a Patient Specific Functional Scale (PSFS) questionnaire at initial evaluation, follow up at session 3 or 4, and at any date of anticipated discharge. Basic demographic data (age, sex), dates of data collection, and any discharge dates will be tracked as well. If questions arise regarding the content of the SEV then the treating physical therapist will be permitted to answer and apply the content at their discretion. All therapists will have pre-approved the content of the video to ensure there are no contradictions to their usual methods of care. Data will be gathered for up to 3 months.
Detailed description
- Human subjects for the study will be recruited and participate in the study at the University of Illinois at Chicago Faculty Practice (UICFP) located at 1640 West Roosevelt Road, 3rd floor, Chicago IL. All of the treating physical therapists with the exception of Daniel Robinson will be participating as treating physical therapists in this study and will therefore be aware of the proceedings involved. The treating physical therapists: Aaron Keil, Brian Baranyi, Justin Payette, Deborah Davey, Benjamin Land, Richelle Caya, Amanda Montbriand, Adam Wielechowski will be screening and obtaining informed consent from study participants. Additionally, Jessica Pop will be assisting in data collection and organization of data for the study.
- Patients receiving physical therapy (PT) at the UICFP will be screened for eligibility according to inclusion and exclusion criteria by treating physical therapists including obtaining consent to participate in the study at date of initial physical therapy evaluation or before the patient leaves from the second follow up visit.
- Checking for inclusion and exclusion criteria will be referenced by the treating therapist from the "Patient Checklist Data Form" (PCDF)
- If a patient does not meet any of the inclusion criteria or meets one of the exclusion criteria they will be excluded from the study.
- If a patient is being added in the above manner on a date past initial evaluation the physical therapist must record previous data needed that is available from patient records (date of evaluation, Patient Specific Functional Scale (PSFS) average score). The PSFS will be provided to all possible candidates in the clinic as part of the standard intake paperwork. Therefore, the PSFS should still be available for data after obtaining consent.
- Upon passing exclusion and inclusion criteria and obtaining informed consent, patients will be randomized into either the control or experimental group. Only after these setup steps will the PCDF be filled out and, if appropriate, provide the Strength Education Video (SEV) for viewing.
- Once included into the study subjects will be randomly assigned to one of two groups: control group (CG) or experimental group (EG).
- CG will receive standard PT care
- EG will receive standard care in addition to being provided a SEV.
- The SEV must be watched by the patient at the UICFP prior to leaving from the 3rd PT visit.
- The EG will watch the video in the waiting room or other quiet available rooms on the 3rd floor within the UICFP.
- The video will be watched from an iPad/tablet/laptop/desktop computer device as available in the clinic.
- The EG will also be provided a handout with a link and QR code to the video on YouTube.com and disclaimer from the consent form.
- Disclaimer quoted from consent form: "Please follow the link bellow to the video hosted on YouTube.com. Please be aware that by viewing the video on YouTube.com you are agreeing to YouTube and Google's terms and conditions. This will not be sharing any of your protected health information held by the University of Illinois Hospital system or the University of Illinois at Chicago. You are not obligated to click on or view this link. It is intended as a helpful tool for your benefit. Please reach out to your treating physical therapist with any questions or concerns"
- Treating physical therapist will record the date of SEV viewing on the PCDF. - The PCDF will be used to record patient information by the treating physical therapist and have a study subject identification (ID) number added by either Daniel Robinson or Jessica Pop when performing data entry described later in protocol.
- Subject information contained in the PCDF includes:
- Treating Physical Therapist
- Patient Name
- Medical Record Number
- Age
- Sex
- Subject ID code
- Which group subject is allocated to (Control or experimental)
- Inclusion criteria checklist
- Exclusion criteria checklist
- Date of evaluation
- Evaluation PSFS score
- Date of SEV viewing (if in EG)
- Session number of SEV viewing (if in EG)
- Follow up PSFS score
- Follow up session number
- Follow up date
- Discharge PSFS score
- Discharge session number
- Discharge date
- Secondary Discharge PSFS score
- Secondary Discharge Session number
- Secondary Discharge date
- Tertiary Discharge PSFS score
- Tertiary Discharge Session number
- Tertiary Discharge date
- Indication if patient was discharged early from PT or had an unplanned discharge from PT.
- PCDF sheets will be kept with physical therapists when being used to gather data or in the UICFP in a locked cabinet/drawer in the folder of the specific physical therapist separate from standard treatment notes.
- Data from the PCDF will be entered without patient names into a Private Data Excel Sheet (PDES). This spreadsheet will be kept in a Box Health Data Folder (BHDF) only available to the study investigators (Daniel Robinson, Jessica Pop, and Brian Baranyi) using a secure password containing at least: one uppercase letter, one lower case letter, one number, one symbol, and at least 8 characters.
- Functional changes with PT will be tracked for both groups using a Patient Specific Functional Scale (PSFS) questionnaire at initial evaluation, follow up at session 3 or 4 (evaluation not counting as a session), and at any date of anticipated discharge.
- The PSFS being utilized has been altered slightly from its original form for the purpose of clarifying to patients that 10 is a high functional performance skill. This is being done due to subjective reports from clinicians that patients commonly misread the questionnaire selecting 10 as a score of low function based on pain being the common question they receive. The changes made do not involve adding any new words or content changes that would be expected to alter nature of answers.
- If questions arise regarding the content of the SEV then the treating physical therapist will be permitted to answer and apply the content at their discretion. All therapists will have pre-approved the content of the video to ensure there are no contradictions to their usual methods of care. Data will be gathered for up to 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be randomly assigned to one of two groups: control group or experimental group. The control group will receive standard PT care and the experimental group will receive standard physical therapy care in addition to being provided a strength education video.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Strength education video, Other: standard PT careExperimental group will receive standard physical therapy care in addition to being provided a strength education video. |
| Control Group | Active comparator | Other: standard PT careThe control group will receive standard physical therapy care at the University of Illinois at Chicago Faculty Practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients receiving physical therapy at the University of Illinois at Chicago Faculty Practice
- Strength training is a component of the intervention plan for physical therapy
- Patient consents to be part of the study prior to leaving from 3rd physical therapy (PT) clinic visit (Eval +2 sessions)
- Age 18 or older
- Has been provided a PSFS on date of initial PT evaluation
Key exclusion criteria (5 listed)
- Medical History of:
- Cognitive/psychological disorder limiting ability to comprehend educational video
- English not preferred language
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 |
|---|---|---|
| Strength education videoThe Strength education video must be watched by the patient at the University of Illinois at Chicago Faculty Practice (UICFP) prior to leaving from the 3rd physical therapy visit. The Experimental Group (EG) will watch the video in the waiting room or other quiet available rooms on the 3rd floor within the UICFP. The video will be watched from an iPad/tablet/laptop/desktop computer device as available in the clinic. The EG will also be provided a handout with a link and quick response code to the video on YouTube.com | Other | Experimental group |
| standard PT carestandard PT care | Other | Control Group, Experimental group |
Primary outcome
Patient Specific Functional Scale
Time frame: 3 months
The Patient Specific Functional Scale (PSFS) is a clinical outcome tool that was designed and validated for the purpose of tracking changes in function for patients with a wide variety of clinical conditions. This is measuring up to three patient identified important activities which are each scored on a 0 to 10 scale. On this scale 0 indicates "unable to perform activity" and 10 indicates "able to perform activity"
Results and safety
The study was stopped early (reason given: COVID pandemic disrupted subject recruitment and primary investigator no longer with our university; no additional interest in continuing the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2020.
- Please see the strength education video for the experimental groupLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data. Data from this study will be compiled for research purposes but not singling out any specific participant or any participant personal identifiers (i.e. name date of birth, etc).
Related trials for Patients Receiving Physical Therapy
Active, not recruitingObservational study
Assessment of Cognitive Function in Breast Cancer and Lymphoma Patients Receiving Chemotherapy
Breast Cancer, Lymphoma
RecruitingObservational study
Step Count and Treatment Response in Neoadjuvant Breast Cancer
Breast Neoplasm Malignant Female, Exercise
Active, not recruiting
Resistance Training Intervention to Improve Physical Function in Patients With Pancreatic Cancer Receiving Combination Chemotherapy or Have Undergone Surgery, PancStrength Study
Advanced Pancreatic Adenocarcinoma, Pancreatic Adenocarcinoma
Not yet recruitingObservational study
Symptoms, Physical Function, and Recovery in Patients Receiving Lung Cancer Treatment Before Surgery
Lung Cancer (Diagnosis), Patient-Reported Symptom Burden
Active, not recruitingPhase 2
Multimodal Therapy for the Treatment of Fatigue in Patients With Prostate Cancer Receiving Radiotherapy With Androgen Deprivation Therapy
Prostate Cancer
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 Strength education video and standard PT care in people with Patients Receiving Physical Therapy, run by University of Illinois Chicago 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 6 inclusion and 5 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: stopped early, as of the sponsor's last update on 7 Dec 2020. 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 was stopped early (reason given: COVID pandemic disrupted subject recruitment and primary investigator no longer with our university; no additional interest in continuing the study.). Results are not available in the source record.
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?
Patient Specific Functional Scale (time frame: 3 months). 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 7 Dec 2020.