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Compression Gloves for Distal Radius Fracture

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Clalit Health Services
Sponsor:
Collaborator:
University of Haifa
Information provided by (Responsible Party):
Uzi Milman, Clalit Health Services
ClinicalTrials.gov Identifier:
NCT01518179
First received: January 21, 2012
Last updated: July 25, 2016
Last verified: July 2016
History of Changes
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Wearing Made-to-Measure Compression Gloves on Rehabilitation Following DRF.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Clalit Health Services:

Primary Outcome Measures:
  • Functional Activities of Daily Living (ADL) by self reported assessment using the Patient Rating Wrist Evaluation (PRWE). [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Functional Activities of Daily Living (ADL) by self reported assessment using the Patient Rating Wrist Evaluation (PRWE).


Secondary Outcome Measures:
  • Swelling of the hand and fingers (using CM ribbon) [ Time Frame: 10 week ] [ Designated as safety issue: No ]
    Swelling of the hand and fingers (using CM ribbon)

  • Range of motion of the fingers and wrist (using Goniomater) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Range of motion of the fingers and wrist (using Goniomater)

  • Strength of the hand (using the Gamar Dynamometer in KG). [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Strength of the hand (using the Gamar Dynamometer in KG).

  • Pain (using VAS as part of PRWE) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Pain (using VAS as part of PRWE)

  • Overall satisfaction of using the compression gloves (using self reported questionnaire). [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Overall satisfaction of using the compression gloves (using self reported questionnaire).
Estimated Enrollment: 120
Study Start Date: April 2012
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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 
Study First Received: January 21, 2012
Last Updated: July 25, 2016
Health Authority: Israel: Ministry of Health

Keywords provided by 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

ClinicalTrials.gov processed this record on September 23, 2016