Compression Gloves for Distal Radius Fracture

January 29, 2019 updated by: Uzi Milman, Clalit Health Services

The Effect of Wearing Made-to-Measure Compression Gloves on Rehabilitation Following DRF.

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Individuals referred for rehabilitation following DRF will be invited to participate in the study. After obtaining an informed consent individuals will be randomized to receive routine follow up and treatment with or without compression glove. Individuals randomized to made to measure compression gloves will receive them within a week of enrolment. All participating individuals will be assessed by an occupational therapist at enrolment and 2, 4, and 8 week after enrolment. Additional telephone interview, to assess long term effect, will be conducted at 3, 6 and 12 months.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel
        • Clalit health services
      • Haifa, Israel
        • Clalit Health Services, Haifa and Western Galilee District

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 4-6 weeks following either surgical or conservative treatment for distal Radius fractures, with or without the involvement of the Ulna.

  2. Patients who demonstrate at enrolment at least two of the following:

    • Pain,
    • limited range of motion of the fingers and the wrist,
    • limited strength (weakness of the hand/fingers),
    • swelling /edema,
    • Limited hand functions during performance of Activities of Daily Living (ADL).

Exclusion Criteria:

  • Neuropathy
  • Peripheral vascular disease
  • End stage renal disease
  • Previous impairment of fingers/wrist range of motion.
  • Previous Lymphedema of the injured hand
  • Receiving any additional treatments which is not included in the routine follow up and treatment (i.e. acupuncture, steroids).
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Made-to-Measure Compression Gloves
Made-to-Measure Compression Gloves in addition to routine follow up and treatment.
Device: Made-to-Measure Compression Gloves
Made-to-Measure Compression Gloves in addition to routine follow up and treatment.
Other: Control
Routine follow up and treatment
Other: Routine follow up and treatment
Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Activities of Daily Living (ADL) by self reported assessment using the Patient Rating Wrist Evaluation (PRWE).
Time Frame: 1 year
Functional Activities of Daily Living (ADL) by self reported assessment using the Patient Rating Wrist Evaluation (PRWE).
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Swelling of the hand and fingers (using CM ribbon)
Time Frame: 10 week
Swelling of the hand and fingers (using CM ribbon)
10 week
Range of motion of the fingers and wrist (using Goniomater)
Time Frame: 10 weeks
Range of motion of the fingers and wrist (using Goniomater)
10 weeks
Strength of the hand (using the Gamar Dynamometer in KG).
Time Frame: 10 weeks
Strength of the hand (using the Gamar Dynamometer in KG).
10 weeks
Pain (using VAS as part of PRWE)
Time Frame: 10 weeks
Pain (using VAS as part of PRWE)
10 weeks
Overall satisfaction of using the compression gloves (using self reported questionnaire).
Time Frame: 10 weeks
Overall satisfaction of using the compression gloves (using self reported questionnaire).
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clalit Health Services

Collaborators

University of Haifa

Investigators

  • Principal Investigator: Benny Brnfeld, MD, Clalit health services
  • Study Director: Uzi Milman, MD, Clalit health services
  • Study Chair: Naomi Schreuer, Ph.D., OTR, Faculty of Social Welfare & Health Sciences, University of Haifa, Haifa, ISRAEL
  • Principal Investigator: Inbar Miler, OCT, Clalit health services

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

January 21, 2012

First Submitted That Met QC Criteria

January 21, 2012

First Posted (Estimate)

January 25, 2012

Study Record Updates

Last Update Posted (Actual)

January 31, 2019

Last Update Submitted That Met QC Criteria

January 29, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K-11-0131-CTIL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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