Distal Radius FractureNCT05850325
Novel Exercises to Facilitate Recovery of Supination and Pronation for Distal Radius Fractures Managed With a Volar Plate
A study testing Group 1 Elbow Flexed at 90 Degrees and Group 2 Elbow Fully Flexed in people with Distal Radius Fracture, run by Indiana Hand to Shoulder Center at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the influence of elbow position on achieving forearm supination and pronation and wrist ROM postoperatively. It is anticipated the results will show recovery of functional motion in a shorter period of time (27 days average). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Group 1 Elbow Flexed at 90 Degrees and Group 2 Elbow Fully Flexed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2022to Apr 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Subjects 18 years of age and older
- Subjects with distal radius fractures with a volar plate
- Subjects attending therapy at the Indiana Hand to Shoulder Center or affiliated satellites.
- Subjects that attend the initial therapy visit between 5 and 10 days postoperative and begin the home therapy program (patient handout)
Who cannot join
- • Subjects under the age of 18
- Additional surgical procedures or other factors preventing early active ROM of the forearm and/or wrist within the initial 10 days following surgery
- Pre-existing medical conditions or injuries with resultant limitation in elbow, forearm or wrist ROM, patient-reported limited function, or limited ability to comply with home program (cognitive skills).
- While undergoing therapy the initial 6 weeks, subjects provided with custom-fabricated or pre-fabricated devices, orthoses, or braces for the specific purpose of passively improving ROM of the elbow, forearm or wrist during the initial 6 weeks of therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana Hand to Shoulder Center
Indianapolis, Indiana, 46260
About this study
The primary objective of this study is to evaluate the influence of elbow position on achieving forearm supination and pronation and wrist ROM postoperatively. It is anticipated the results will show recovery of functional motion in a shorter period of time (27 days average). As for the secondary objective of the study, it is anticipated there will be limited pain and cost-containment. These data elements will serve as secondary factors to evaluate.
Read the detailed description
The current standard of care for forearm range of motion exercises is to position the elbow in 90 degrees of flexion at the side of the body for both supination and pronation.5,6 This study will compare standard of care forearm rotation exercises to exercising with the elbow in extension to facilitate pronation and exercising with the elbow in full flexion to facilitate supination in patients who have undergone surgery with a volar plate for distal radius fractures. We hypothesize that forearm motion will be achieved in a shorter number of days and with a greater arc of motion when the exercises are done in extremes of elbow flexion and extension.
This will be a prospective, unblinded, randomized study to evaluate forearm range of motion across two groups:
Control Group: subjects will be instructed to exercise the forearm with the elbow positioned by their side, in 90° of flexion.
Test Group: subjects will be instructed to exercise the forearm with their elbow fully flexed to achieve supination and the elbow extended to achieve pronation.
Randomization will occur post-operatively after the patient has signed consent to participate. Randomization will occur through a computerized random allocation and groups will be assigned by the Clinical Research Manager or designee.
- Conditions
- Distal Radius Fracture
- Being tested
- Group 1 Elbow Flexed at 90 Degrees, Group 2 Elbow Fully Flexed
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1 Elbow Flexed at 90 DegreesOther
Also called Elbow Flexed to 90 Degrees
subjects will be instructed to exercise the forearm with the elbow positioned by their side, in 90° of flexion.
Group 2 Elbow Fully FlexedOther
Also called Elbow Fully Flexed
subjects will be instructed to exercise the forearm with their elbow fully flexed to achieve supination and the elbow extended to achieve pronation.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Elbow Flexed at 90 Degrees | Other | subjects will be instructed to exercise the forearm with the elbow positioned by their side, in 90° of flexion. Receives: Other: Group 1 Elbow Flexed at 90 Degrees |
| Group 2: Elbow Fully Flexed | Experimental | subjects will be instructed to exercise the forearm with their elbow fully flexed to achieve supination and the elbow extended to achieve pronation. Receives: Other: Group 2 Elbow Fully Flexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motion
forearm supination and pronation and wrist ROm
Measured: 6 Months
Secondary outcomes (2)
Upper Limb Functional Index (ULFI)
PROM functional questionnaire
Measured: 6 Months
QuickDisability of the Arm Shoulder Hand (DASH)
PROM - functional questionnaire
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start16 Dec 2022
- Primary completionDec 2023 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FractureStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana Hand to Shoulder Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05850325
- Sponsor's protocol ID
- DR VP ROM
- Status last verified
- Apr 2023
- First submitted
- 18 Apr 2023
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Exercises to Facilitate Recovery of Supination and Pronation for Distal Radius Fractures Managed With a Volar Plate
- ClinicalTrials.gov ID
- NCT05850325
- Acronym / sponsor ID
- DR VP ROM
- Conditions
- Distal Radius Fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Indiana Hand to Shoulder CenterUniversity, hospital or other
- Study start
- 16 Dec 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 9 May 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 primary objective of this study is to evaluate the influence of elbow position on achieving forearm supination and pronation and wrist ROM postoperatively. It is anticipated the results will show recovery of functional motion in a shorter period of time (27 days average). As for the secondary objective of the study, it is anticipated there will be limited pain and cost-containment. These data elements will serve as secondary factors to evaluate.
Detailed description
The current standard of care for forearm range of motion exercises is to position the elbow in 90 degrees of flexion at the side of the body for both supination and pronation.5,6 This study will compare standard of care forearm rotation exercises to exercising with the elbow in extension to facilitate pronation and exercising with the elbow in full flexion to facilitate supination in patients who have undergone surgery with a volar plate for distal radius fractures. We hypothesize that forearm motion will be achieved in a shorter number of days and with a greater arc of motion when the exercises are done in extremes of elbow flexion and extension.
This will be a prospective, unblinded, randomized study to evaluate forearm range of motion across two groups:
Control Group: subjects will be instructed to exercise the forearm with the elbow positioned by their side, in 90° of flexion.
Test Group: subjects will be instructed to exercise the forearm with their elbow fully flexed to achieve supination and the elbow extended to achieve pronation.
Randomization will occur post-operatively after the patient has signed consent to participate. Randomization will occur through a computerized random allocation and groups will be assigned by the Clinical Research Manager or designee.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Elbow Flexed at 90 Degrees | Other | Other: Group 1 Elbow Flexed at 90 Degreessubjects will be instructed to exercise the forearm with the elbow positioned by their side, in 90° of flexion. |
| Group 2: Elbow Fully Flexed | Experimental | Other: Group 2 Elbow Fully Flexedsubjects will be instructed to exercise the forearm with their elbow fully flexed to achieve supination and the elbow extended to achieve pronation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Subjects 18 years of age and older
Key exclusion criteria (4 listed)
- • Subjects under the age of 18
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 |
|---|---|---|
| Group 1 Elbow Flexed at 90 DegreesAlso: Elbow Flexed to 90 Degreessubjects will be instructed to exercise the forearm with the elbow positioned by their side, in 90° of flexion. | Other | Group 1: Elbow Flexed at 90 Degrees |
| Group 2 Elbow Fully FlexedAlso: Elbow Fully Flexedsubjects will be instructed to exercise the forearm with their elbow fully flexed to achieve supination and the elbow extended to achieve pronation. | Other | Group 2: Elbow Fully Flexed |
Primary outcome
Range of Motion
Time frame: 6 Months
forearm supination and pronation and wrist ROm
2 secondary outcomes
Upper Limb Functional Index (ULFI)
Time frame: 6 Months
QuickDisability of the Arm Shoulder Hand (DASH)
Time frame: 6 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1 Elbow Flexed at 90 Degrees and Group 2 Elbow Fully Flexed in people with Distal Radius Fracture, run by Indiana Hand to Shoulder Center 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 9 May 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?
Results are not available in the source record.
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?
Range of Motion (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 May 2023.