Implementation of the Dart-throwing Motion Plane in Hand Therapy After Distal Radius Fractures

NCT ID: NCT03918174

Last Updated: 2019-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-15
• Study Completion Date: 2019-03-17

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.

Conditions

Distal Radius Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dart Splint orthosis

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.

Group Type: EXPERIMENTAL

Dart splint orthosis

Intervention Type: DEVICE

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.

The conventional treatment

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.

Group Type: EXPERIMENTAL

Conventional treatment

Intervention Type: OTHER

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.

Interventions

Dart splint orthosis

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.

Intervention Type: DEVICE

Conventional treatment

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.

Intervention Type: OTHER

Other Intervention Names

Conventional treatment

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sigal Portnoy, PhD

Role: STUDY_CHAIR

Tel Aviv University

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

SHEBA-15-2085-YY-CTIL

Identifier Type: -

Identifier Source: org_study_id