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Compression Gloves for Distal Radius Fracture

Primary Purpose

Distal Radius Fractures, Fracture of Lower End of Radius, Colles' Fracture

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Made-to-Measure Compression Gloves
Routine follow up and treatment
Sponsored by
Clalit Health Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fractures focused on measuring Colles' Fracture, Compression Bandages, Occupational therapy, Rehabilitation, Smith's fracture

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clalit Health Services, Haifa and Western Galilee District
  • Clalit Health Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Made-to-Measure Compression Gloves

Control

Arm Description

Made-to-Measure Compression Gloves in addition to routine follow up and treatment.

Routine follow up and treatment

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Swelling of the hand and fingers (using CM ribbon)
Swelling of the hand and fingers (using CM ribbon)
Range of motion of the fingers and wrist (using Goniomater)
Range of motion of the fingers and wrist (using Goniomater)
Strength of the hand (using the Gamar Dynamometer in KG).
Strength of the hand (using the Gamar Dynamometer in KG).
Pain (using VAS as part of PRWE)
Pain (using VAS as part of PRWE)
Overall satisfaction of using the compression gloves (using self reported questionnaire).
Overall satisfaction of using the compression gloves (using self reported questionnaire).

Full Information

First Posted
January 21, 2012
Last Updated
January 29, 2019
Sponsor
Clalit Health Services
Collaborators
University of Haifa
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1. Study Identification

Unique Protocol Identification Number
NCT01518179
Brief Title
Compression Gloves for Distal Radius Fracture
Official Title
The Effect of Wearing Made-to-Measure Compression Gloves on Rehabilitation Following DRF.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clalit Health Services
Collaborators
University of Haifa

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fractures, Fracture of Lower End of Radius, Colles' Fracture, Smith's Fracture
Keywords
Colles' Fracture, Compression Bandages, Occupational therapy, Rehabilitation, Smith's fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Made-to-Measure Compression Gloves
Arm Type
Experimental
Arm Description
Made-to-Measure Compression Gloves in addition to routine follow up and treatment.
Arm Title
Control
Arm Type
Other
Arm Description
Routine follow up and treatment
Intervention Type
Device
Intervention Name(s)
Made-to-Measure Compression Gloves
Intervention Description
Made-to-Measure Compression Gloves in addition to routine follow up and treatment.
Intervention Type
Other
Intervention Name(s)
Routine follow up and treatment
Intervention Description
Control
Primary Outcome Measure Information:
Title
Functional Activities of Daily Living (ADL) by self reported assessment using the Patient Rating Wrist Evaluation (PRWE).
Description
Functional Activities of Daily Living (ADL) by self reported assessment using the Patient Rating Wrist Evaluation (PRWE).
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Swelling of the hand and fingers (using CM ribbon)
Description
Swelling of the hand and fingers (using CM ribbon)
Time Frame
10 week
Title
Range of motion of the fingers and wrist (using Goniomater)
Description
Range of motion of the fingers and wrist (using Goniomater)
Time Frame
10 weeks
Title
Strength of the hand (using the Gamar Dynamometer in KG).
Description
Strength of the hand (using the Gamar Dynamometer in KG).
Time Frame
10 weeks
Title
Pain (using VAS as part of PRWE)
Description
Pain (using VAS as part of PRWE)
Time Frame
10 weeks
Title
Overall satisfaction of using the compression gloves (using self reported questionnaire).
Description
Overall satisfaction of using the compression gloves (using self reported questionnaire).
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benny Brnfeld, MD
Organizational Affiliation
Clalit Health Services
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Uzi Milman, MD
Organizational Affiliation
Clalit Health Services
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Naomi Schreuer, Ph.D., OTR
Organizational Affiliation
Faculty of Social Welfare & Health Sciences, University of Haifa, Haifa, ISRAEL
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Inbar Miler, OCT
Organizational Affiliation
Clalit Health Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clalit Health Services, Haifa and Western Galilee District
City
Haifa
Country
Israel
Facility Name
Clalit Health Services
City
Haifa
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
29994792
Citation
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.
Results Reference
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Compression Gloves for Distal Radius Fracture

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