Distal Radius Fractures Clinical Trial
Official title:
The Effect of Wearing Made-to-Measure Compression Gloves on Rehabilitation Following DRF.
Verified date | January 2019 |
Source | Clalit Health Services |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)
Status | Completed |
Enrollment | 35 |
Est. completion date | December 31, 2018 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Israel | Clalit Health Services | Haifa | |
Israel | Clalit Health Services, Haifa and Western Galilee District | Haifa |
Lead Sponsor | Collaborator |
---|---|
Clalit Health Services | University of Haifa |
Israel,
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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Swelling of the hand and fingers (using CM ribbon) | Swelling of the hand and fingers (using CM ribbon) | 10 week | |
Secondary | Range of motion of the fingers and wrist (using Goniomater) | Range of motion of the fingers and wrist (using Goniomater) | 10 weeks | |
Secondary | Strength of the hand (using the Gamar Dynamometer in KG). | Strength of the hand (using the Gamar Dynamometer in KG). | 10 weeks | |
Secondary | Pain (using VAS as part of PRWE) | Pain (using VAS as part of PRWE) | 10 weeks | |
Secondary | Overall satisfaction of using the compression gloves (using self reported questionnaire). | Overall satisfaction of using the compression gloves (using self reported questionnaire). | 10 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT06453447 -
Prednisone for CRPS in Distal Radius Fracture
|
N/A | |
Recruiting |
NCT06136286 -
ORIF Distal Radius Blood Flow Restriction Therapy
|
N/A | |
Not yet recruiting |
NCT06078371 -
Opioid-Free Pain Treatment in Trauma Patients
|
N/A | |
Not yet recruiting |
NCT05902442 -
A Clinical Comparison of Patient-specific 3D Printed Splints Versus Conventional Splints in the Treatment of Distal Radius Fractures.
|
N/A | |
Completed |
NCT02990052 -
Conservative Treatment vs. Volar Plating of Distal Radius Fractures
|
N/A | |
Withdrawn |
NCT00788190 -
Treatment of Distal Radius Fractures in Elderly Patients
|
N/A | |
Completed |
NCT06343467 -
Do Generic Volar Locking Plates Provide Similar Outcomes at a Reduced Cost?
|
N/A | |
Recruiting |
NCT06046404 -
Refraining From Closed Reduction of Dislocated Distal Radius Fractures in the Emergency Department
|
N/A | |
Not yet recruiting |
NCT06251206 -
Impact of Early ADL Education on Outcomes Post DRF ORIF
|
Phase 1 | |
Completed |
NCT00654615 -
Fixation of Unstable Distal Radius Fractures
|
N/A | |
Completed |
NCT01937624 -
Pediatric Distal Radius US Study
|
||
Completed |
NCT01007565 -
Postoperative Pain After Volar Plating for Distal Radius Fractures
|
Phase 2 | |
Terminated |
NCT01859468 -
A Study Comparing the Effect of Amorphous Calcium Carbonate (ACC) on Healing Time of Distal Radius Fractures
|
Phase 1/Phase 2 | |
Completed |
NCT01103297 -
2.4 mm Variable Angle LCP Two-Column Volar Distal Radius
|
Phase 4 | |
Completed |
NCT05942950 -
Predicting Outcomes of Distal Radius Fractures: a Surgeon Survey
|
||
Completed |
NCT06215872 -
Effectiveness of Structured Myofacial Chain Exercises After Distal Radius Fracture
|
N/A | |
Suspended |
NCT01693094 -
A Randomized Trial Measuring the Effect of Decision Aids on Patients' Satisfaction, Conflict of Decision-making and Clinical Outcome
|
N/A | |
Not yet recruiting |
NCT06235957 -
Three Weeks of Cast Immobilisation Versus One Week of Brace Immobilisation in Distal Radius Fractures
|
N/A | |
Recruiting |
NCT06019585 -
Inmobilization With Compression Bandage vs Antebraquial Splint in Distal Radius Fractures
|
N/A | |
Terminated |
NCT02802774 -
Immobilization of Postoperative Distal Radius Fractures
|
N/A |