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
|
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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 |
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 |
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
|
- 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).
- Swelling of the hand and fingers (using CM ribbon) [ Time Frame: 10 week ]Swelling of the hand and fingers (using CM ribbon)
- Range of motion of the fingers and wrist (using Goniomater) [ Time Frame: 10 weeks ]Range of motion of the fingers and wrist (using Goniomater)
- Strength of the hand (using the Gamar Dynamometer in KG). [ Time Frame: 10 weeks ]Strength of the hand (using the Gamar Dynamometer in KG).
- Pain (using VAS as part of PRWE) [ Time Frame: 10 weeks ]Pain (using VAS as part of PRWE)
- 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).

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 4-6 weeks following either surgical or conservative treatment for distal Radius fractures, with or without the involvement of the Ulna.
-
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

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
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 | |
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 |
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 |
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 |