NCT06155617

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 13, 2017

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2023

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 4, 2023

Completed
Last Updated

December 4, 2023

Status Verified

October 1, 2023

Enrollment Period

5.5 years

First QC Date

August 24, 2023

Last Update Submit

November 30, 2023

Conditions

Hand Injuries and DisordersUpper Extremity Problem

Keywords

PRESS to FunctionPainRange of MotionEdemaSensationStrengthQuick DASHUpper ExtremityHand

Outcome Measures

Primary Outcomes (1)

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

    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 Outcomes (6)

  • Pain Scale

    4 weeks - 16 weeks depending on diagnosis and protocol

  • Range of Motion (ROM)

    4 weeks - 16 weeks depending on diagnosis and protocol

  • Edema

    4 weeks - 16 weeks depending on diagnosis and protocol

  • Sensibility

    4 weeks - 16 weeks depending on diagnosis and protocol

  • Strength (Grip and Pinch)

    4 weeks - 16 weeks depending on diagnosis and protocol

  • +1 more secondary outcomes

Study Arms (1)

Single Arm Clinical Trial

OTHER

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

Interventions

Upper Extremity RehabilitationOTHER

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

Single Arm Clinical Trial

Eligibility Criteria

Age21 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pinnacle Hand Therapy

Newport News, Virginia, 23606, United States

Location

Related Publications (3)

  • American Occupational Therapy Association. (2020). Occupational therapy practice framework: Domain and process (4th ed,) American Journal of Occupational Therapy, 74 ( Suppl. 2).

    BACKGROUND

  • Bohannon RW. Test-Retest Reliability of Measurements of Hand-Grip Strength Obtained by Dynamometry from Older Adults: A Systematic Review of Research in the PubMed Database. J Frailty Aging. 2017;6(2):83-87. doi: 10.14283/jfa.2017.8.

    PMID: 28555708RESULT

  • Hoe VC, Urquhart DM, Kelsall HL, Zamri EN, Sim MR. Ergonomic interventions for preventing work-related musculoskeletal disorders of the upper limb and neck among office workers. Cochrane Database Syst Rev. 2018 Oct 23;10(10):CD008570. doi: 10.1002/14651858.CD008570.pub3.

    PMID: 30350850RESULT

MeSH Terms

Conditions

Hand InjuriesDiseasePainEdema

Condition Hierarchy (Ancestors)

Wounds and InjuriesPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Phyllis Ross, OTD

    Howard University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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 Scores
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2023

First Posted

December 4, 2023

Study Start

November 13, 2017

Primary Completion

May 5, 2023

Study Completion

May 24, 2023

Last Updated

December 4, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)