Compression Gloves for Distal Radius Fracture
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)
Distal Radius Fractures
Fracture of Lower End of Radius
Device: Made-to-Measure Compression Gloves
|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.|
- 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).
- 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).
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Device: Made-to-Measure Compression Gloves
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01518179
|Contact: Uzi Milman, MDfirstname.lastname@example.org ; email@example.com|
|Contact: Maria Kostenko, MSfirstname.lastname@example.org|
|Clalit Health Services||Recruiting|
|Principal Investigator: Benny Bernfeld, MD|
|Clalit Health Services, Haifa and Western Galilee District||Recruiting|
|Contact: Uzi Milman, MD 972-50-6261360 email@example.com|
|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|