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Compression Gloves for Distal Radius Fracture
This study is currently recruiting participants.
Verified July 2016 by Uzi Milman, Clalit Health Services
Sponsor:
Clalit Health Services
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
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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 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:
Further study details as provided by Uzi Milman, 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 ]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 ]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).
| 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) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
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
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 |
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 |
ClinicalTrials.gov processed this record on June 27, 2017