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

Sponsor
Howard University (Other)
Overall Status
Completed
CT.gov ID
NCT06155617
Collaborator
(none)
30
1
1
66.3
0.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Upper Extremity Rehabilitation
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Single arm clinical trial. T-test employed to compare PRESS to Function scores before and after treatment. Reliability coefficient were computed to access consistency in the measurements of the Quick DASH and the PRESS to Function ScoresSingle arm clinical trial. T-test employed to compare PRESS to Function scores before and after treatment. Reliability coefficient were computed to access consistency in the measurements of the Quick DASH and the PRESS to Function Scores
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Development and Reliability of the PRESS to Function Approach: A Systematic Method for Upper Extremity Assessment
Actual Study Start Date :
Nov 13, 2017
Actual Primary Completion Date :
May 5, 2023
Actual Study Completion Date :
May 24, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  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

  2. 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.

  3. 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.

  4. 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

  5. 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

  6. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pinnacle Hand Therapy Newport News Virginia United States 23606

Sponsors and Collaborators

  • Howard University

Investigators

  • Principal Investigator: Phyllis Ross, OTD, Howard University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Howard University
ClinicalTrials.gov Identifier:
NCT06155617
Other Study ID Numbers:
  • IRB-20-PNAH-08
First Posted:
Dec 4, 2023
Last Update Posted:
Dec 4, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Howard University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 4, 2023