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Compression Gloves for Distal Radius Fracture

NCT01518179 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2019-01-31

No results posted yet for this study

Summary

Distal Radius Fractures are among the most common orthopedic injuries. Rehabilitation may be characterized by pain, stiffness, swelling, and decreased range of motion (hand and fingers), and grip strength.

Compression gloves are used to enhance rehabilitation after various clinical conditions and injuries. However, there are no reports on the effect of compression gloves following Distal Radius Fracture (DRF).

This study aims to assess the incremental effect of wearing Made-to-Measure Compression Gloves on rehabilitation following DRF.

Working Hypothesis: The addition of Made-to-Measure Compression Gloves to routine follow up and treatment will enhance rehabilitation, when compared with routine follow up and treatment, in patients following Distal Radius Fracture.

ICD 10, Version 2010, conditions to be included in the study (defined jointly as Distal Radius Fractures):

S52.5 Fracture of lower end of radius (Colles' fracture, Smith's fracture) S52.6 Fracture of lower end of both ulna and radius S52.7 Multiple fractures of forearm Excl.: fractures of both ulna and radius: lower end (S52.6), shafts (S52.4).

S52.8 Fracture of other parts of forearm (Lower end of ulna, Head of ulna)

Conditions

  • Distal Radius Fractures
  • Fracture of Lower End of Radius
  • Colles' Fracture
  • Smith's Fracture

Interventions

DEVICE

Made-to-Measure Compression Gloves

Made-to-Measure Compression Gloves in addition to routine follow up and treatment.

OTHER

Routine follow up and treatment

Control

Sponsors & Collaborators

  • University of Haifa

    collaborator OTHER

  • Clalit Health Services

    lead OTHER

Principal Investigators

  • Benny Brnfeld, MD · Clalit Health Services

  • Uzi Milman, MD · Clalit Health Services

  • Naomi Schreuer, Ph.D., OTR · Faculty of Social Welfare & Health Sciences, University of Haifa, Haifa, ISRAEL

  • Inbar Miler, OCT · Clalit Health Services

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01518179 on ClinicalTrials.gov