Distal Radius FracturesNCT06299228
Is Sensorimotor Training Effective Following a Distal Radius Fracture?
A study testing Experimental Group in people with Distal Radius Fractures, run by Hand Surgery Associates LLC at 1 site in United States.
Trial summary
The purpose of this study is to compare the short-term outcomes of individuals who have surgery (volar plate) for a wrist (distal radius) fracture who have routine hand therapy treatment versus routine hand therapy treatment and sensorimotor activities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Radius Fractures
- What is being tested?
- Experimental Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2024to Apr 2025
- 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
- Distal radius fracture with volar plate fixation
- Understand English
- 18 years or older
- Available to attend skilled occupational therapy visits a minimum of 1x per week.
Who cannot join
- Prior surgery to the involved wrist/hand
- Cognitive impairment
- Distal radius fracture managed by casting or by another means of fixation
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Hand Surgery Associates
Olyphant, Pennsylvania, 18447
Nancy Naughton, OTD, 570-780-8681, nancynaughton10@gmail.com
Lori Algar, OTD, 2034514938, Lori.Algar@gmail.com
About this study
Official title: Sensorimotor Training and Hand Therapy Versus Traditional Hand Therapy Alone Following a Distal Radius Fracture With Volar Plate Fixation: A Randomized Controlled Trial
The purpose of this study is to compare the short-term outcomes of individuals who have surgery (volar plate) for a wrist (distal radius) fracture who have routine hand therapy treatment versus routine hand therapy treatment and sensorimotor activities. Individuals who meet inclusion criteria at the facilities collecting data will be invited to participate. If they agree to participate, they will randomly and blindly (via concealed envelopes) be assigned to the control (routine treatment) or the sensorimotor treatment group. Data collection will occur at 3- and 6-weeks post initiation of skilled therapy and will include measurement of joint position sense, function via the Patient Rated Wrist and Hand, pain via the Numeric Pain Rating Scale, and range of motion at the digits and wrist.
Read the detailed description
The study is an interventional study investigating the effectiveness of sensorimotor activities in addition to traditional occupational therapy intervention versus traditional intervention only for patients following a distal radius fracture with volar plate fixation. A convenience sample of patients from 2 outpatient orthopedic hand therapy departments will be invited to participate in the study.
The treatment for both groups will be identical with one group receiving the addition of sensorimotor activities. Participants will be divided into one of the two groups. They will be made aware that at any point they can choose to no longer participate in the study, and it will not affect their treatment.
- Conditions
- Distal Radius Fractures
- Being tested
- Experimental Group, Control Group
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental GroupOther
Sensorimotor intervention, active range of motion, active assisted range of motion, strengthening
Control GroupOther
Active range of motion, active assisted range of motion and strengthening
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The experimental group will receive sensorimotor intervention and traditional hand therapy Receives: Other: Experimental Group |
| Control Group | Experimental | Control Group will receive Hand Therapy only Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active Joint Position Sense (AJPS)
Range of motion measurement for the wrist, the measurements are recorded in degress of motion and the greater the number of degrees is reflective of greater sensorimotor deficit
Measured: Baseline, 3 and 6 weeks
Secondary outcomes (1)
Patient Rated Wrist and Hand Evaluation
Patient reported outcome measurement with a 0-100 range, 0 indicating no functional deficit and 100 indicating the worst functional scale
Measured: Baseline, 3 and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study startApr 2024 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FracturesStudies 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
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hand Surgery Associates LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Touro University Nevada, Orthopaedic Specialty Group PC, Fairfield
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299228
- Sponsor's protocol ID
- HSA
- Status last verified
- Apr 2024
- First submitted
- 1 Mar 2024
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only the researchers identified will have access to the participant data. 2 of the 3 researchers identified will be collecting the data.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensorimotor Training and Hand Therapy Versus Traditional Hand Therapy Alone Following a Distal Radius Fracture With Volar Plate Fixation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06299228
- Acronym / sponsor ID
- HSA
- Conditions
- Distal Radius Fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hand Surgery Associates LLCUniversity, hospital or other
- Collaborators
- Touro University Nevada, Orthopaedic Specialty Group PC, Fairfield
- Study start
- Apr 2024 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 7 Mar 2024 (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 purpose of this study is to compare the short-term outcomes of individuals who have surgery (volar plate) for a wrist (distal radius) fracture who have routine hand therapy treatment versus routine hand therapy treatment and sensorimotor activities. Individuals who meet inclusion criteria at the facilities collecting data will be invited to participate. If they agree to participate, they will randomly and blindly (via concealed envelopes) be assigned to the control (routine treatment) or the sensorimotor treatment group. Data collection will occur at 3- and 6-weeks post initiation of skilled therapy and will include measurement of joint position sense, function via the Patient Rated Wrist and Hand, pain via the Numeric Pain Rating Scale, and range of motion at the digits and wrist.
Detailed description
The study is an interventional study investigating the effectiveness of sensorimotor activities in addition to traditional occupational therapy intervention versus traditional intervention only for patients following a distal radius fracture with volar plate fixation. A convenience sample of patients from 2 outpatient orthopedic hand therapy departments will be invited to participate in the study.
The treatment for both groups will be identical with one group receiving the addition of sensorimotor activities. Participants will be divided into one of the two groups. They will be made aware that at any point they can choose to no longer participate in the study, and it will not affect their treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Experimental GroupThe experimental group will receive sensorimotor intervention and traditional hand therapy |
| Control Group | Experimental | Other: Control GroupControl Group will receive Hand Therapy only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Distal radius fracture with volar plate fixation
- Understand English
- 18 years or older
- Available to attend skilled occupational therapy visits a minimum of 1x per week.
Key exclusion criteria (3 listed)
- Prior surgery to the involved wrist/hand
- Cognitive impairment
- Distal radius fracture managed by casting or by another means of fixation
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 |
|---|---|---|
| Experimental GroupSensorimotor intervention, active range of motion, active assisted range of motion, strengthening | Other | Experimental Group |
| Control GroupActive range of motion, active assisted range of motion and strengthening | Other | Control Group |
Primary outcome
Active Joint Position Sense (AJPS)
Time frame: Baseline, 3 and 6 weeks
Range of motion measurement for the wrist, the measurements are recorded in degress of motion and the greater the number of degrees is reflective of greater sensorimotor deficit
1 secondary outcome
Patient Rated Wrist and Hand Evaluation
Time frame: Baseline, 3 and 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Individual participant dataSharing planned: No. Only the researchers identified will have access to the participant data. 2 of the 3 researchers identified will be collecting the data.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Group in people with Distal Radius Fractures, run by Hand Surgery Associates LLC 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 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: status not confirmed, as of the sponsor's last update on 29 Apr 2024. 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?
Contact Nancy Naughton, OTD (5707808681, nancynaughton10@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Active Joint Position Sense (AJPS) (time frame: Baseline, 3 and 6 weeks). 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 29 Apr 2024.