Clinical trial NCT03918174: Implementation of the Dart-throwing Motion Plane in Hand Therapy After Distal Radius Fractures
Official title: Efficacy of Treatment After Distal Radius Fractures Using Dart-throwing Motion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distal Radius Fracture
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-04-17
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 18 to 65 years old
* Went through open reduction internal fixation of distal radius fracture.

Exclusion Criteria:

* Individuals with previous orthopedic impairments of the upper limb.
* Individuals with neurological impairments of the upper limb.
* Individuals with a cognitive impairment.

Primary outcomes:
measure: A personal questionnaire
timeFrame: baseline
measure: A house hold work and sport activity questionnaire
timeFrame: baseline
measure: Change in the forearm and wrist range of motion
timeFrame: Change from baseline forearm and wrist range of motion at two months
measure: Change in reported pain and function on The Patient-Rated Wrist Evaluation (PRWE) questionnaire.
timeFrame: Change from baseline pain and function at two months
measure: Change in hand function on The Jebsen-Taylor Hand Function Test (JHFT)
timeFrame: Change from baseline hand function at two months
measure: Grip strength
timeFrame: Following the intervention at two months
measure: Pinch strength
timeFrame: Following the intervention at two months
measure: Satisfaction from the self-training
timeFrame: Following the intervention at two months
measure: Quebec User Evaluation of Satisfaction with assistive Technology (QUEST) questionnaire
timeFrame: Following the intervention at two months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tel Aviv University
name: Sigal Portnoy, PhD
role: STUDY_CHAIR
References: