Compression Gloves for Distal Radius Fracture

This study is currently recruiting participants.
Verified May 2012 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: May 1, 2012
Last verified: May 2012

January 21, 2012
May 1, 2012
April 2012
March 2014   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01518179 on ClinicalTrials.gov Archive Site
  • 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).
Same as current
Not Provided
Not Provided
 
Compression Gloves for Distal Radius Fracture
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)

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Distal Radius Fractures
  • Fracture of Lower End of Radius
  • Colles' Fracture
  • Smith's Fracture
Device: Made-to-Measure Compression Gloves
Made-to-Measure Compression Gloves in addition to routine follow up and treatment.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
March 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
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
Israel
 
NCT01518179
K-11-0131-CTIL
No
Uzi Milman, Clalit Health Services
Clalit Health Services
University of Haifa
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
Clalit Health Services
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP