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Compression Gloves for Distal Radius Fracture

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ClinicalTrials.gov Identifier: NCT01518179
Recruitment Status : Recruiting
First Posted : January 25, 2012
Last Update Posted : January 25, 2018
Sponsor:
Collaborator:
University of Haifa
Information provided by (Responsible Party):
Uzi Milman, Clalit Health Services

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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)


Condition or disease Intervention/treatment Phase
Distal Radius Fractures Fracture of Lower End of Radius Colles' Fracture Smith's Fracture Device: Made-to-Measure Compression Gloves Other: Routine follow up and treatment Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Wearing Made-to-Measure Compression Gloves on Rehabilitation Following DRF.
Study Start Date : April 2012
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.
Control
Routine follow up and treatment
 Other: Routine follow up and treatment
Control


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Swelling of the hand and fingers (using CM ribbon) [ Time Frame: 10 week ]
    Swelling of the hand and fingers (using CM ribbon)

  2. Range of motion of the fingers and wrist (using Goniomater) [ Time Frame: 10 weeks ]
    Range of motion of the fingers and wrist (using Goniomater)

  3. Strength of the hand (using the Gamar Dynamometer in KG). [ Time Frame: 10 weeks ]
    Strength of the hand (using the Gamar Dynamometer in KG).

  4. Pain (using VAS as part of PRWE) [ Time Frame: 10 weeks ]
    Pain (using VAS as part of PRWE)

  5. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01518179


Contacts
Contact: Uzi Milman, MD 972-50-6261360 uzimi@clalit.org.il ; uzimy@netvision.net.il
Contact: Maria Kostenko, MS 972-4-8507468 mariako@clalit.org.il

Locations
Israel
Clalit Health Services, Haifa and Western Galilee District Recruiting
Haifa, Israel
Contact: Uzi Milman, MD    972-50-6261360    uzimy@netvision.net.il   
Clalit Health Services Recruiting
Haifa, Israel
Principal Investigator: Benny Bernfeld, MD         
Sponsors and Collaborators
Clalit Health Services
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
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Uzi Milman, Director, clinical research unit, Clalit Health Services, Haifa, Clalit Health Services
ClinicalTrials.gov Identifier: NCT01518179     History of Changes
Other Study ID Numbers: K-11-0131-CTIL
First Posted: January 25, 2012    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018

Keywords provided by Uzi Milman, Clalit Health Services:
Colles' Fracture
Compression Bandages
Occupational therapy
Rehabilitation
Smith's fracture

Additional relevant MeSH terms:
Fractures, Bone
Radius Fractures
Colles' Fracture
Wounds and Injuries
Forearm Injuries
 Arm Injuries
Fracture Dislocation
Joint Dislocations
Bone Diseases
Musculoskeletal Diseases