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

Not Applicable

Completed

• Conditions: Upper Extremity Problem; Hand Injuries and Disorders

• Registration Number: NCT06155617
• Lead Sponsor: Howard University

Brief Summary

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.

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 Timeline

• Study Start: 2017-11-13
• Primary Completion: 2023-05-05
• Study Completion: 2023-05-24
• Study First Submitted: 2023-08-24
• Status Verified: 2023-10
• Study First Submitted QC: 2023-11-30
• Last Update Submitted: 2023-11-30
• Study First Posted: 2023-12-04
• Last Update Posted: 2023-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Development and Reliability of PRESS to Function Approach: A Systematic Method for Upper Extremity Assessment	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 Outcome Measures

Name	Time	Method
Strength (Grip and Pinch)	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
Function with Quick Disability of the Arm, Shoulder, and Hand (DASH)	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.
Range of Motion (ROM)	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.
Edema	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.
Sensibility	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
Pain Scale	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

Trial Locations

Locations (1)

Pinnacle Hand Therapy; 🇺🇸 Newport News, Virginia, United States