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Completed

NCT Number: NCT06155617

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

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.

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Key information

Conditions

Hand Injuries and Disorders Disease Edema Hand Injuries Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Upper Extremity Problem Wounds and Injuries

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pinnacle Hand Therapy

Newport News, Virginia, 23606, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Upper extremity rehabilitation

Other

Pain management, ROM, Edema Management, Desensitization, Strengthening, Functional Tasks

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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. 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

  5. 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

  6. 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.

Sponsors and collaborators

Lead sponsor

Howard University

Other

Registry information

Official study title

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

Acronym: PRESS

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Dec 4, 2023
Registry last updated
Dec 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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