Distal Radius FractureNCT04089709
Well-arm Exercise in Distal Radius Fractures
A study testing Well-arm Exercise in people with Distal Radius Fracture, run by Henry Ford Health System at 1 site in United States.
Trial summary
A single center randomized control study. Patients >18 years with isolated distal radius fractures treated non-operatively will be randomly assigned to either the treatment group (exercise of contralateral "well" arm) or control group (standard fracture care and rehabilitation). 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?
- Well-arm Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2019to 20 Mar 2020
- 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
- Adults >18 years with an isolated distal radius fracture treated non-operatively
Who cannot join
- Operative treatment, additional injures, previous injury to same arm, neuropathy or neuromuscular disease, dementia
Trial locations and contacts
1 site in 1 country.
About this study
A single center randomized control study. Patients >18 years with isolated distal radius fractures treated non-operatively will be randomly assigned to either the treatment group (exercise of contralateral "well" arm) or control group (standard fracture care and rehabilitation).
Read the detailed description
Distal radius fractures are common injuries, especially in the aging population. Fracture healing requires immobilization of the injury, which inevitably leads to muscle atrophy and joint stiffness. This strength lost during immobilization can be problematic in patients who are already de-conditioned at baseline. Previous research using healthy participants found that exercising a non-immobilized, "well", arm helped attenuate muscle atrophy in the contralateral immobilized arm. The study aims to answer the following questions: Does exercise of the contralateral arm prevent muscle atrophy and weakness of the injured arm? Does exercise of the contralateral arm improve pain scores in the injured arm
- Conditions
- Distal Radius Fracture
- Being tested
- Well-arm Exercise
- Keywords
- Distal radius fracture, cross-education, immobilization
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Well-arm ExerciseBehavioural
Patients randomized to the treatment arm will perform these exercises on the contralateral arm once daily for 3 months: wrist flexion and extension, ball or sock squeeze, wrist curls and biceps curls. Participants allocated to this study arm will be provided a print out of the exercises with detailed explanations and pictures of each exercise.
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | Patients randomized to this group will be provided exercises to perform with the uninjured arm once daily for 3 months. Receives: Behavioral: Well-arm Exercise |
| Control arm | No intervention | Patients randomized to this group will not be provided exercises for the "well-arm" and will be managed according to the current standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grip strength
Grip strength will be measured using a dynamometer at all clinic visits.
Measured: 3 months
Forearm Circumference
Forearm circumference will be measured at the widest point of the forearm, approximately 2cm distal to the elbow. This measurement will be taken at all clinic visits.
Measured: 3 months
Secondary outcomes (1)
Pain scores of injured arm.
A visual analog scale (VAS) score will be collected at the first and all subsequent clinic visits.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study start30 Nov 2019
- Primary completion20 Mar 2020
- Study completion20 Mar 2020
Why it stopped: Covid-19
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two groups, treatment or no treatment. Randomizations will be balanced at random accrual points.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Trent Guthrie, Henry Ford Health System
- Investigators
- Stuart T Guthrie, MD, Principal investigator, Henry Ford Hospital System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04089709
- Sponsor's protocol ID
- 11912
- Status last verified
- Jul 2022
- First submitted
- 12 Sep 2019
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Well-arm Exercise in Distal Radius Fractures
- ClinicalTrials.gov ID
- NCT04089709
- Acronym / sponsor ID
- 11912
- Conditions
- Distal Radius Fracture
- Keywords
- Distal radius fracture, cross-education, immobilization
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Covid-19
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 30 Nov 2019 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 13 Sep 2019 (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.
A single center randomized control study. Patients >18 years with isolated distal radius fractures treated non-operatively will be randomly assigned to either the treatment group (exercise of contralateral "well" arm) or control group (standard fracture care and rehabilitation).
Detailed description
Distal radius fractures are common injuries, especially in the aging population. Fracture healing requires immobilization of the injury, which inevitably leads to muscle atrophy and joint stiffness. This strength lost during immobilization can be problematic in patients who are already de-conditioned at baseline. Previous research using healthy participants found that exercising a non-immobilized, "well", arm helped attenuate muscle atrophy in the contralateral immobilized arm. The study aims to answer the following questions: Does exercise of the contralateral arm prevent muscle atrophy and weakness of the injured arm? Does exercise of the contralateral arm improve pain scores in the injured arm
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two groups, treatment or no treatment. Randomizations will be balanced at random accrual points.
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Behavioral: Well-arm ExercisePatients randomized to this group will be provided exercises to perform with the uninjured arm once daily for 3 months. |
| Control arm | No intervention | –Patients randomized to this group will not be provided exercises for the "well-arm" and will be managed according to the current standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults >18 years with an isolated distal radius fracture treated non-operatively
Key exclusion criteria (1 listed)
- Operative treatment, additional injures, previous injury to same arm, neuropathy or neuromuscular disease, dementia
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 |
|---|---|---|
| Well-arm ExercisePatients randomized to the treatment arm will perform these exercises on the contralateral arm once daily for 3 months: wrist flexion and extension, ball or sock squeeze, wrist curls and biceps curls. Participants allocated to this study arm will be provided a print out of the exercises with detailed explanations and pictures of each exercise. | Behavioural | Study arm |
Primary outcome
Grip strength
Time frame: 3 months
Grip strength will be measured using a dynamometer at all clinic visits.
Forearm Circumference
Time frame: 3 months
Forearm circumference will be measured at the widest point of the forearm, approximately 2cm distal to the elbow. This measurement will be taken at all clinic visits.
1 secondary outcome
Pain scores of injured arm.
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Covid-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
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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.
Stuart T Guthrie, MD principal investigator
Henry Ford Hospital System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Well-arm Exercise in people with Distal Radius Fracture, run by Henry Ford Health System 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 25 Jul 2022. 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 was stopped early (reason given: Covid-19). 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?
Grip strength (time frame: 3 months). The study lists 2 primary outcomes in all. 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 25 Jul 2022.