Compression Gloves for Distal Radius Fracture
The Effect of Wearing Made-to-Measure Compression Gloves on Rehabilitation Following DRF.
1 other identifier
interventional
35
1 country
2
Brief Summary
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2012
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2012
CompletedFirst Posted
Study publicly available on registry
January 25, 2012
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedJanuary 31, 2019
January 1, 2019
6.8 years
January 21, 2012
January 29, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Functional Activities of Daily Living (ADL) by self reported assessment using the Patient Rating Wrist Evaluation (PRWE).
Functional Activities of Daily Living (ADL) by self reported assessment using the Patient Rating Wrist Evaluation (PRWE).
1 year
Secondary Outcomes (5)
Swelling of the hand and fingers (using CM ribbon)
10 week
Range of motion of the fingers and wrist (using Goniomater)
10 weeks
Strength of the hand (using the Gamar Dynamometer in KG).
10 weeks
Pain (using VAS as part of PRWE)
10 weeks
Overall satisfaction of using the compression gloves (using self reported questionnaire).
10 weeks
Study Arms (2)
Made-to-Measure Compression Gloves
EXPERIMENTALMade-to-Measure Compression Gloves in addition to routine follow up and treatment.
Control
OTHERRoutine follow up and treatment
Interventions
Made-to-Measure Compression Gloves in addition to routine follow up and treatment.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Clalit Health Serviceslead
- University of Haifacollaborator
Study Sites (2)
Clalit Health Services, Haifa and Western Galilee District
Haifa, Israel
Clalit Health Services
Haifa, Israel
Related Publications (1)
Miller-Shahabar I, Schreuer N, Katsevman H, Bernfeld B, Cons A, Raisman Y, Milman U. Efficacy of Compression Gloves in the Rehabilitation of Distal Radius Fractures: Randomized Controlled Study. Am J Phys Med Rehabil. 2018 Dec;97(12):904-910. doi: 10.1097/PHM.0000000000000998.
PMID: 29994792RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, clinical research unit, Clalit Health Services, Haifa
Study Record Dates
First Submitted
January 21, 2012
First Posted
January 25, 2012
Study Start
April 1, 2012
Primary Completion
December 31, 2018
Study Completion
December 31, 2018
Last Updated
January 31, 2019
Record last verified: 2019-01