Pain, Range of Motion, Edema, Sensibility, Strength (PRESS) & Self-reported Function Create a Comprehensive Score (PRESS)

November 30, 2023 updated by: Howard University

Development and Reliability of the PRESS to Function Approach: A Systematic Method for Upper Extremity Assessment

The aim of this study is to examine the development of a conceptual framework and provide evidence for reliability of a comprehensive hand therapy evaluation score. This approach provides a new standardized tool for upper extremity (UE) evaluation. Components of Pain, Range of Motion (ROM), Edema, Sensibility, Strength (PRESS), and self-reported Function were combined to create a baseline. Each assessment tool used for the PRESS to Function Approach assists in determining appropriate interventions.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In this study, investigators used the innovative PRESS to Function Approach and Composite Score to describe the development and piloting of a systematic standard for upper extremity evaluation. Using existing instruments with substantial evidence of validity and reliability is more cost-effective than starting from scratch to develop and validate an instrument. This Approach and Score will provide occupational therapists an accurate measure to track the progression of a patient. The hypothesis for this study is Press to Function components will demonstrate utility for measuring clinical and patient-reported function when used as a comprehensive assessment tool.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Pinnacle Hand Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Clinical diagnosis of upper extremity disorder as the primary diagnosis
  • Surgical and nonsurgical Diagnoses
  • Age 21 years or older

Exclusion Criteria:

  • Concomitant Diseases (i.e cerebralvascular accident, cerebral palsy, spinal cord injury)
  • Full Body Lymphedema
  • Individuals who did not complete at least one reassessment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Single Arm Clinical Trial
Participants with various upper extremity disorders are provided treatment/interventions and evaluated at baseline, 3-6 weeks, and at discharge using the PRESS to Function Approach
Other: Upper Extremity Rehabilitation
Pain management, ROM, Edema Management, Desensitization, Strengthening, Functional Tasks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Development and Reliability of PRESS to Function Approach: A Systematic Method for Upper Extremity Assessment
Time Frame: 4 weeks - 16 weeks depending on diagnosis and protocol
The Development of the PRESS (pain, range of motion (ROM), edema, sensibility, strength) to Function Approach created a composite score. The PRESS to Function Composite Score combines subjective and objective measures to provide a single value to evaluate treatment prognosis. The six outcome measures (pain, ROM, edema, sensibility, strength, and function) were summed for 900 points to create a single score. The higher the score the less the overall disability.
4 weeks - 16 weeks depending on diagnosis and protocol

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain Scale
Time Frame: 4 weeks - 16 weeks depending on diagnosis and protocol
Pain was measured using the Numerical Pain Rating Scale (NPRS) and descriptors. The NPRS is indicative of a rating 0 through 10. The zero represents no pain and the 10 represents the worst imaginable pain
4 weeks - 16 weeks depending on diagnosis and protocol
Range of Motion (ROM)
Time Frame: 4 weeks - 16 weeks depending on diagnosis and protocol
For ROM, joints were measured with a goniometer. The unit of measurement is in degrees. Measurements range from 0 to 180 degrees. Each joint is compared to normative data. Zero represents the neutral and the least amount of motion.
4 weeks - 16 weeks depending on diagnosis and protocol
Edema
Time Frame: 4 weeks - 16 weeks depending on diagnosis and protocol
Edema considered both upper extremities (right and left) using a standard tape measure. The measurements were recorded according to units in centimeters (cm). Anatomical landmarks were chosen strategically for a ratio comparison as well as to establish baseline. Smaller numbers represent less edema or swelling.
4 weeks - 16 weeks depending on diagnosis and protocol
Sensibility
Time Frame: 4 weeks - 16 weeks depending on diagnosis and protocol
Sensibility was measured with Semmes Weinstein Monofilaments to determine sensory loss and touch pressure. The filaments are classified from grade 1 to 5 according to their thickness, where 5 represents the thinnest filament and 1 represents the largest filament: 1.65-2.83 = grade 5, 3.22-3.61 = grade 4, 3.84-4.31 = grade 3, 4.56-6.45 = grade 2, and 6.65 = grade 1
4 weeks - 16 weeks depending on diagnosis and protocol
Strength (Grip and Pinch)
Time Frame: 4 weeks - 16 weeks depending on diagnosis and protocol
Measured with the dynamometer and the pinch gauge in pounds. The higher the the number the stronger the patient. Strength may range from 0 pounds (weak) to 200 pounds (strong).There will be a comparison in some cases with normative data based on age and gender
4 weeks - 16 weeks depending on diagnosis and protocol
Function with Quick Disability of the Arm, Shoulder, and Hand (DASH)
Time Frame: 4 weeks - 16 weeks depending on diagnosis and protocol
The Quick DASH questionnaire is a Likert scale that uses 11 questions to measure the degree of difficulty in performing various physical activities. Due to a shoulder, arm, or hand problem questions address the severity of pain and tingling, the limitation on social activities, work, and sleep. All 11 self-report items must be completed to receive a score on a scale between 0-to-100 with the higher scores reflecting greater disability.
4 weeks - 16 weeks depending on diagnosis and protocol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Howard University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Phyllis Ross, OTD, Howard University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 13, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 5, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 24, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 24, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB-20-PNAH-08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings