Distal Radius FractureNCT03918174
Implementation of the Dart-throwing Motion Plane in Hand Therapy After Distal Radius Fractures
A study testing Dart splint orthosis and Conventional treatment in people with Distal Radius Fracture, run by Sheba Medical Center.
Trial summary
Rehabilitation following wrist fractures often includes exercising flexion-extension. However, during daily functions, our wrist moves through an oblique plane, named the Dart Throwing Motion (DTM) plane. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Dart splint orthosis and Conventional treatment
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2015to 17 Mar 2019
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 65 years old
- Went through open reduction internal fixation of distal radius fracture.
Who cannot join
- Individuals with previous orthopedic impairments of the upper limb.
- Individuals with neurological impairments of the upper limb.
- Individuals with a cognitive impairment.
About this study
Official title: Efficacy of Treatment After Distal Radius Fractures Using Dart-throwing Motion
Rehabilitation following wrist fractures often includes exercising flexion-extension. However, during daily functions, our wrist moves through an oblique plane, named the Dart Throwing Motion (DTM) plane. This plane might be a more stable plane in cases of wrist injuries, since the proximal carpal row remains relatively immobile. However, rehabilitation programs that incorporate exercising in the DTM plane have yet to be explored.
The researchers aimed to evaluate the rehabilitation outcomes following treatment in the DTM plane compared with outcomes following treatment in the sagittal plane after Distal Radius Fracture (DRFs).
Twenty four subjects following internal fixation of DRFs were randomly assigned into a research group . The range of motion, pain levels and functional tests were measured before and after an intervention of 12 treatment sessions. The control group activated the wrist in the sagittal plane while the research group activated the wrist in the DTM plane, via a DTM orthosis.
Read the detailed description
Twenty four subjects were recruited after Open Reduction Internal Fixation (ORIF) of DRFs. Inclusion criteria were: individuals aged 18 to 65 years. Individuals with previous orthopedic or neurological impairments of the upper limb or a cognitive impairment were excluded from the study. Subjects were enrolled from the department of hand surgery at the Sheba medical center.
Each subject read and signed an informed consent form pretrial. Each subject went through an intake session documenting personal information, upper limb ROM, pain levels and functional tests recorded by a certified occupational therapist (OT), hand therapist. The Sagittal group activated the wrist mostly in the sagittal plane while the research group activated the wrist also in the DTM plane, via the Modified Dart Splint (MDS).
All of the subjects in both groups received 12 therapy sessions, 30 minutes each one, 2-3 times a week, during 6-8 weeks following the removal of the cast. Certified hand therapists used several different treatment techniques during the sessions, to achieve the primary goals of edema control, increased Range of Motion (ROM), and decreased stiffness. Compressive wrap with retrograde massage, scar management, soft-tissue mobilization, joint mobilization, active motion and ROM exercises were practice patterns used in this study for all subjects, regardless their group. Both groups were instructed to exercise at home, 3 times a day, 10 minutes per exercise session. The MDS was fitted to the subjects in the DTM group on their first evaluation session. They received oral and written instructions regarding the donning and manner of exercise. Specifically, they were instructed to use the MDS at home. For each 10-minute exercise session, they were asked to perform 5 minutes of radial-extension under resistance and then 5 minutes ulnar-flexion under resistance. In addition, this group was required to fill in a chart at the end of each practice session (morning, noon and evening), throughout the intervention period. The researcher performed weekly phone calls to remind the DTM group to fill these out. The Sagittal group was instructed to perform at home active wrist motion similar to that practiced during the supervised therapy sessions. The prescribed instructions were similar to the exercises performed during the sessions.
At the completion of the treatment, the subjects were reexamined by the same evaluator that performed the baseline evaluation.
- Conditions
- Distal Radius Fracture
- Being tested
- Dart splint orthosis, Conventional treatment
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dart splint orthosisDevice
Also called Conventional treatment
The Dart Splint orthosis was fitted to the subjects in the research group on their first evaluation session. They received oral and written instructions regarding the donning and manner of exercise. Specifically, they were instructed to use the Dart splint orthosis at home. For each 10-minute exercise session, they were asked to perform 5 minutes of radial-extension under resistance and then 5 minutes ulnar-flexion under resistance. In addition, this group was required to fill in a chart at the end of each practice session (morning, noon and evening), throughout the intervention period.
Conventional treatmentOther
The control group activated the wrist mostly in the sagittal plane. This group was instructed to perform at home active wrist motion similar to that practiced during the supervised therapy sessions. The prescribed instructions were similar to the exercises performed during the sessions. Specifically, they were instructed to exercise at home for 10-minute in each session, three times a day (morning, noon and evening), throughout the intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Dart Splint orthosis | Experimental | The Dart-Splint orthosis allows oblique wrist motion along the Dart Throwing Motion (DTM) plane, thus inhibiting movement of the healing structures following surgery around the distal radius. This is a hinged orthosis that permits selective midcarpal mobilization along the plane of the DTM is a novel orthotic device that was developed in order to facilitate protected midcarpal motion. Receives: Device: Dart splint orthosis |
| The conventional treatment | Experimental | The control group activated the wrist mostly in the sagittal plane. This group was instructed to perform at home active wrist motion similar to that practiced during the supervised therapy sessions. The prescribed instructions were similar to the exercises performed during the sessions. Receives: Other: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
A personal questionnaire
6 questions regarding personal information (age, sex, family status, profession, hand dominance, and injured hand).
Measured: baseline
A house hold work and sport activity questionnaire
10 questions regarding house hold activities (heavy housing and light housing) and sport activities (athletics, spinning, cycling, ball, racket, weights, swimming) were ranked on a Likert scale from 1-4 according to the daily, weekly or monthly amount of time put in to them.
Measured: baseline
Change in the forearm and wrist range of motion
The elbow and wrist active range of motions were measured during pro-supination, flexion-extension, radio-ulnar deviation. Additionally, the DTM plane angle of the wrist was measured according to Bugden's (Bugden, B. (2013). A proposed method of goniometric measurement of the dart-throwers motion. Journal of Hand Therapy, 26(1), 77-80. https://doi.org/10.1016/j.jht.2012.08.003)
Measured: Change from baseline forearm and wrist range of motion at two months
Change in reported pain and function on The Patient-Rated Wrist Evaluation (PRWE) questionnaire.
The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in ADL (activities of daily living).
The PRWE allows patients to rate their levels of wrist pain and disability from 0 to 10, and consists of 2 subscales:
Pain subscale: contains 5 items each of which is further rated from 1-10. The maximum score in this section is 50 and minimum 0.
Function subscale: contains total 10 items which are further divided into 2 sections i.e specific activities (having 6 items) and usual activities (having 4 items). The maximum score in this section is 50 and minimum 0.
Measured: Change from baseline pain and function at two months
Change in hand function on The Jebsen-Taylor Hand Function Test (JHFT)
The Jebsen-Taylor Hand Function Test (JHFT) was carried out to assess fine motor skills, weighted and non-weighted hand function activities during performance of ADLs and the effectiveness of treatment for hand conditions. Seven subsets of the test represent a broad spectrum of hand function, which includes writing, turning over 3x5 inch cards (to simulate page turning), picking up small common objects, simulated feeding, stacking checkers, picking up large light objects, and picking up large heavy objects. To evaluate patient performance, each subset is timed and can be compared to the established norms
Measured: Change from baseline hand function at two months
Grip strength
The Jamar hand dynamometer was used to measure grip strength. Grip strength was measured with the elbow flexed at 90° and the forearm in neutral rotation. A single measure of grip strength was performed during assessment. The second handle position of the dynamometer was used throughout testing.
Measured: Following the intervention at two months
Pinch strength
The B\&L engineering pinch gauge pinch meter was used to measure the three pinch strength outcomes: Lateral pinch, Tripod pinch and tip to tip pinch.
Measured: Following the intervention at two months
Satisfaction from the self-training
Satisfaction from the self-training home exercises was rated using a 5-point Likert scale (1- Not satisfied to 5- Extremely satisfied) for 10 statements re self-training home exercises.
Measured: Following the intervention at two months
Quebec User Evaluation of Satisfaction with assistive Technology (QUEST) questionnaire
The Quebec User Evaluation of Satisfaction with assistive Technology (QUEST) questionnaire, measured the level of satisfaction attributed to assistive technologies, i.e., the DTM orthosis (for the research group only). This questionnaire contained 27 variables which were scored in terms of perceived importance and satisfaction.
Measured: Following the intervention at two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start15 Nov 2015
- Primary completion14 Oct 2018
- Study completion17 Mar 2019
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.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- After enrollment, subjects were randomly divided into the research group and into the control group. Both groups went through the same intake evaluation. On completion of the intervention, both groups were reevaluated and filled out a satisfaction questionnaire. The research group alone filled out the Quebec User Evaluation of Satisfaction with assistive Technology (QUEST) questionnaire, to measure the level of satisfaction attribute to assistive technologies, e.g., the innovative dart splint they exercised with.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sigal Portnoy, PhD, Study chair, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03918174
- Sponsor's protocol ID
- SHEBA-15-2085-YY-CTIL
- Status last verified
- Apr 2019
- First submitted
- 1 Apr 2019
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only statistical outcome measure are to be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Treatment After Distal Radius Fractures Using Dart-throwing Motion
- ClinicalTrials.gov ID
- NCT03918174
- Acronym / sponsor ID
- SHEBA-15-2085-YY-CTIL
- Conditions
- Distal Radius Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 15 Nov 2015 (actual)
- Primary completion
- 14 Oct 2018 (actual)
- Study completion
- 17 Mar 2019 (actual)
- First posted
- 17 Apr 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.
Rehabilitation following wrist fractures often includes exercising flexion-extension. However, during daily functions, our wrist moves through an oblique plane, named the Dart Throwing Motion (DTM) plane. This plane might be a more stable plane in cases of wrist injuries, since the proximal carpal row remains relatively immobile. However, rehabilitation programs that incorporate exercising in the DTM plane have yet to be explored.
The researchers aimed to evaluate the rehabilitation outcomes following treatment in the DTM plane compared with outcomes following treatment in the sagittal plane after Distal Radius Fracture (DRFs).
Twenty four subjects following internal fixation of DRFs were randomly assigned into a research group . The range of motion, pain levels and functional tests were measured before and after an intervention of 12 treatment sessions. The control group activated the wrist in the sagittal plane while the research group activated the wrist in the DTM plane, via a DTM orthosis.
Detailed description
Twenty four subjects were recruited after Open Reduction Internal Fixation (ORIF) of DRFs. Inclusion criteria were: individuals aged 18 to 65 years. Individuals with previous orthopedic or neurological impairments of the upper limb or a cognitive impairment were excluded from the study. Subjects were enrolled from the department of hand surgery at the Sheba medical center.
Each subject read and signed an informed consent form pretrial. Each subject went through an intake session documenting personal information, upper limb ROM, pain levels and functional tests recorded by a certified occupational therapist (OT), hand therapist. The Sagittal group activated the wrist mostly in the sagittal plane while the research group activated the wrist also in the DTM plane, via the Modified Dart Splint (MDS).
All of the subjects in both groups received 12 therapy sessions, 30 minutes each one, 2-3 times a week, during 6-8 weeks following the removal of the cast. Certified hand therapists used several different treatment techniques during the sessions, to achieve the primary goals of edema control, increased Range of Motion (ROM), and decreased stiffness. Compressive wrap with retrograde massage, scar management, soft-tissue mobilization, joint mobilization, active motion and ROM exercises were practice patterns used in this study for all subjects, regardless their group. Both groups were instructed to exercise at home, 3 times a day, 10 minutes per exercise session. The MDS was fitted to the subjects in the DTM group on their first evaluation session. They received oral and written instructions regarding the donning and manner of exercise. Specifically, they were instructed to use the MDS at home. For each 10-minute exercise session, they were asked to perform 5 minutes of radial-extension under resistance and then 5 minutes ulnar-flexion under resistance. In addition, this group was required to fill in a chart at the end of each practice session (morning, noon and evening), throughout the intervention period. The researcher performed weekly phone calls to remind the DTM group to fill these out. The Sagittal group was instructed to perform at home active wrist motion similar to that practiced during the supervised therapy sessions. The prescribed instructions were similar to the exercises performed during the sessions.
At the completion of the treatment, the subjects were reexamined by the same evaluator that performed the baseline evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After enrollment, subjects were randomly divided into the research group and into the control group. Both groups went through the same intake evaluation. On completion of the intervention, both groups were reevaluated and filled out a satisfaction questionnaire. The research group alone filled out the Quebec User Evaluation of Satisfaction with assistive Technology (QUEST) questionnaire, to measure the level of satisfaction attribute to assistive technologies, e.g., the innovative dart splint they exercised with.
| Arm | Type | Receives |
|---|---|---|
| Dart Splint orthosis | Experimental | Device: Dart splint orthosisThe Dart-Splint orthosis allows oblique wrist motion along the Dart Throwing Motion (DTM) plane, thus inhibiting movement of the healing structures following surgery around the distal radius. This is a hinged orthosis that permits selective midcarpal mobilization along the plane of the DTM is a novel orthotic device that was developed in order to facilitate protected midcarpal motion. |
| The conventional treatment | Experimental | Other: Conventional treatmentThe control group activated the wrist mostly in the sagittal plane. This group was instructed to perform at home active wrist motion similar to that practiced during the supervised therapy sessions. The prescribed instructions were similar to the exercises performed during the sessions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 to 65 years old
- Went through open reduction internal fixation of distal radius fracture.
Key exclusion criteria (3 listed)
- Individuals with previous orthopedic impairments of the upper limb.
- Individuals with neurological impairments of the upper limb.
- Individuals with a cognitive impairment.
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 |
|---|---|---|
| Dart splint orthosisAlso: Conventional treatmentThe Dart Splint orthosis was fitted to the subjects in the research group on their first evaluation session. They received oral and written instructions regarding the donning and manner of exercise. Specifically, they were instructed to use the Dart splint orthosis at home. For each 10-minute exercise session, they were asked to perform 5 minutes of radial-extension under resistance and then 5 minutes ulnar-flexion under resistance. In addition, this group was required to fill in a chart at the end of each practice session (morning, noon and evening), throughout the intervention period. | Device | Dart Splint orthosis |
| Conventional treatmentThe control group activated the wrist mostly in the sagittal plane. This group was instructed to perform at home active wrist motion similar to that practiced during the supervised therapy sessions. The prescribed instructions were similar to the exercises performed during the sessions. Specifically, they were instructed to exercise at home for 10-minute in each session, three times a day (morning, noon and evening), throughout the intervention period. | Other | The conventional treatment |
Primary outcome
A personal questionnaire
Time frame: baseline
6 questions regarding personal information (age, sex, family status, profession, hand dominance, and injured hand).
A house hold work and sport activity questionnaire
Time frame: baseline
10 questions regarding house hold activities (heavy housing and light housing) and sport activities (athletics, spinning, cycling, ball, racket, weights, swimming) were ranked on a Likert scale from 1-4 according to the daily, weekly or monthly amount of time put in to them.
Change in the forearm and wrist range of motion
Time frame: Change from baseline forearm and wrist range of motion at two months
The elbow and wrist active range of motions were measured during pro-supination, flexion-extension, radio-ulnar deviation. Additionally, the DTM plane angle of the wrist was measured according to Bugden's (Bugden, B. (2013). A proposed method of goniometric measurement of the dart-throwers motion. Journal of Hand Therapy, 26(1), 77-80. https://doi.org/10.1016/j.jht.2012.08.003)
Change in reported pain and function on The Patient-Rated Wrist Evaluation (PRWE) questionnaire.
Time frame: Change from baseline pain and function at two months
The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in ADL (activities of daily living). The PRWE allows patients to rate their levels of wrist pain and disability from 0 to 10, and consists of 2 subscales: Pain subscale: contains 5 items each of which is further rated from 1-10. The maximum score in this section is 50 and minimum 0. Function subscale: contains total 10 items which are further divided into 2 sections i.e specific activities (having 6 items) and usual activities (having 4 items). The maximum score in this section is 50 and minimum 0.
Change in hand function on The Jebsen-Taylor Hand Function Test (JHFT)
Time frame: Change from baseline hand function at two months
The Jebsen-Taylor Hand Function Test (JHFT) was carried out to assess fine motor skills, weighted and non-weighted hand function activities during performance of ADLs and the effectiveness of treatment for hand conditions. Seven subsets of the test represent a broad spectrum of hand function, which includes writing, turning over 3x5 inch cards (to simulate page turning), picking up small common objects, simulated feeding, stacking checkers, picking up large light objects, and picking up large heavy objects. To evaluate patient performance, each subset is timed and can be compared to the established norms
Grip strength
Time frame: Following the intervention at two months
The Jamar hand dynamometer was used to measure grip strength. Grip strength was measured with the elbow flexed at 90° and the forearm in neutral rotation. A single measure of grip strength was performed during assessment. The second handle position of the dynamometer was used throughout testing.
Pinch strength
Time frame: Following the intervention at two months
The B\&L engineering pinch gauge pinch meter was used to measure the three pinch strength outcomes: Lateral pinch, Tripod pinch and tip to tip pinch.
Satisfaction from the self-training
Time frame: Following the intervention at two months
Satisfaction from the self-training home exercises was rated using a 5-point Likert scale (1- Not satisfied to 5- Extremely satisfied) for 10 statements re self-training home exercises.
Quebec User Evaluation of Satisfaction with assistive Technology (QUEST) questionnaire
Time frame: Following the intervention at two months
The Quebec User Evaluation of Satisfaction with assistive Technology (QUEST) questionnaire, measured the level of satisfaction attributed to assistive technologies, i.e., the DTM orthosis (for the research group only). This questionnaire contained 27 variables which were scored in terms of perceived importance and satisfaction.
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 17 Apr 2019.
- Individual participant dataSharing planned: No. Only statistical outcome measure are to be shared with other researchers.
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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.
Sigal Portnoy, PhD study chair
Tel Aviv University
Questions about this trial
What is this clinical trial studying?
A study testing Dart splint orthosis and Conventional treatment in people with Distal Radius Fracture, run by Sheba Medical Center.
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 2 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 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
A personal questionnaire (time frame: baseline). The study lists 9 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 17 Apr 2019.