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Does a Video-based Education Tool Related to Strengthening Result in Different Functional Outcomes Compared to Traditional Physical Therapy Education for Patients?

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ClinicalTrials.gov Identifier: NCT04245852
Recruitment Status : Terminated (COVID pandemic disrupted subject recruitment and primary investigator no longer with our university; no additional interest in continuing the study.)
First Posted : January 29, 2020
Last Update Posted : December 7, 2020
Sponsor:
Information provided by (Responsible Party):
Brian Thomas Baranyi, University of Illinois at Chicago

Brief 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 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.

Condition or disease Intervention/treatment Phase
Patients Receiving Physical Therapy Other: Strength education video Other: standard PT care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Does a Video-based Education Tool Related to Strengthening Result in Different Functional Outcomes Compared to Traditional Physical Therapy Education for Patients?
Actual Study Start Date : February 11, 2020
Actual Primary Completion Date : November 16, 2020
Actual Study Completion Date : November 16, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Experimental: Experimental group
Experimental group will receive standard physical therapy care in addition to being provided a strength education video.
Other: Strength education video
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

Other: standard PT care
standard PT care

Active Comparator: Control Group
The control group will receive standard physical therapy care at the University of Illinois at Chicago Faculty Practice.
Other: standard PT care
standard PT care




Primary Outcome Measures :
  1. 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"



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04245852


Locations
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United States, Illinois
University of Illinois at Chicago Physical Therapy Faculty Practice
Chicago, Illinois, United States, 60608
Sponsors and Collaborators
University of Illinois at Chicago
Additional Information:
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Responsible Party: Brian Thomas Baranyi, Clinical Assistant Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT04245852    
Other Study ID Numbers: 2020-0007
First Posted: January 29, 2020    Key Record Dates
Last Update Posted: December 7, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No