Hand Injuries and DisordersPRESSNCT06155617
Pain, Range of Motion, Edema, Sensibility, Strength (PRESS) & Self-reported Function Create a Comprehensive Score
A study testing Upper Extremity Rehabilitation in people with Hand Injuries and Disorders and Upper Extremity Problem, run by Howard University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Hand Injuries and Disorders, Upper Extremity Problem
- What is being tested?
- Upper Extremity Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2017to 24 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of upper extremity disorder as the primary diagnosis
- Surgical and nonsurgical Diagnoses
- Age 21 years or older
Who cannot join
- Concomitant Diseases (i.e cerebralvascular accident, cerebral palsy, spinal cord injury)
- Full Body Lymphedema
- Individuals who did not complete at least one reassessment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Upper Extremity Rehabilitation
- Keywords
- PRESS to Function, Pain, Range of Motion, Edema, Sensation, Strength, Quick DASH, Upper Extremity, Hand
- Medical subject headings
- Hand Injuries, Disease, Pain, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper Extremity RehabilitationOther
Pain management, ROM, Edema Management, Desensitization, Strengthening, Functional Tasks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Upper Extremity Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks - 16 weeks depending on diagnosis and protocol
Secondary outcomes (6)
Pain Scale
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
Measured: 4 weeks - 16 weeks depending on diagnosis and protocol
Range of Motion (ROM)
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.
Measured: 4 weeks - 16 weeks depending on diagnosis and protocol
Edema
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.
Measured: 4 weeks - 16 weeks depending on diagnosis and protocol
Sensibility
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
Measured: 4 weeks - 16 weeks depending on diagnosis and protocol
Strength (Grip and Pinch)
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
Measured: 4 weeks - 16 weeks depending on diagnosis and protocol
Function with Quick Disability of the Arm, Shoulder, and Hand (DASH)
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.
Measured: 4 weeks - 16 weeks depending on diagnosis and protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start13 Nov 2017
- Primary completion5 May 2023
- Study completion24 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hand Injuries and DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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 Scores
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Howard University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Phyllis Ross, OTD, Principal investigator, Howard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06155617
- Sponsor's protocol ID
- IRB-20-PNAH-08
- Acronym
- PRESS
- Status last verified
- Oct 2023
- First submitted
- 24 Aug 2023
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
American Occupational Therapy Association. (2020). Occupational therapy practice framework: Domain and process (4th ed,) American Journal of Occupational Therapy, 74 ( Suppl. 2).
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.
PubMed 28555708Hoe 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.
PubMed 30350850
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Reliability of the PRESS to Function Approach: A Systematic Method for Upper Extremity Assessment
- ClinicalTrials.gov ID
- NCT06155617
- Acronym / sponsor ID
- PRESS / IRB-20-PNAH-08
- Keywords
- PRESS to Function, Pain, Range of Motion, Edema, Sensation, Strength, Quick DASH, Upper Extremity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Howard UniversityUniversity, hospital or other
- Study start
- 13 Nov 2017 (actual)
- Primary completion
- 5 May 2023 (actual)
- Study completion
- 24 May 2023 (actual)
- First posted
- 4 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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 Scores
| Arm | Type | Receives |
|---|---|---|
| Single Arm Clinical Trial | Other | Other: Upper Extremity RehabilitationParticipants 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 |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of upper extremity disorder as the primary diagnosis
- Surgical and nonsurgical Diagnoses
- Age 21 years or older
Key exclusion criteria (3 listed)
- Concomitant Diseases (i.e cerebralvascular accident, cerebral palsy, spinal cord injury)
- Full Body Lymphedema
- Individuals who did not complete at least one reassessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Upper Extremity RehabilitationPain management, ROM, Edema Management, Desensitization, Strengthening, Functional Tasks | Other | Single Arm Clinical Trial |
Primary outcome
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.
6 secondary outcomes
Pain Scale
Time frame: 4 weeks - 16 weeks depending on diagnosis and protocol
Range of Motion (ROM)
Time frame: 4 weeks - 16 weeks depending on diagnosis and protocol
Edema
Time frame: 4 weeks - 16 weeks depending on diagnosis and protocol
Sensibility
Time frame: 4 weeks - 16 weeks depending on diagnosis and protocol
Strength (Grip and Pinch)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- BackgroundAmerican Occupational Therapy Association. (2020). Occupational therapy practice framework: Domain and process (4th ed,) American Journal of Occupational Therapy, 74 ( Suppl. 2).
- Results publication: PubMed 28555708Bohannon 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.
- Results publication: PubMed 30350850Hoe 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phyllis Ross, OTD principal investigator
Howard University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper Extremity Rehabilitation in people with Hand Injuries and Disorders and Upper Extremity Problem, run by Howard University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06155617, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023.