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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

30

Phase

  • 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

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
Intervention / Treatment
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

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

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

Howard University

Investigators

  • 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)

November 13, 2017

Primary Completion (Actual)

May 5, 2023

Study Completion (Actual)

May 24, 2023

Study Registration Dates

First Submitted

August 24, 2023

First Submitted That Met QC Criteria

November 30, 2023

First Posted (Estimated)

December 4, 2023

Study Record Updates

Last Update Posted (Estimated)

December 4, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

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