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Patients With Distal Radius Fracture

Primary Purpose

Physical Disability

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
12 weeks physical therapy programme
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Physical Disability focused on measuring Distal radius fracture, functional status, activity participation, hand therapy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged between 18 and 60
  • Diagnosed with distal radius fracture
  • Primary fixation after injury.

Exclusion Criteria:

  • Bilateral distal radius fracture
  • Concomitant ulna styloid fracture
  • Another orthopaedic, neurological or rheumatologic problem involving the ipsilateral upper limb
  • Patients who underwent surgery that involved ipsilateral upper extremity
  • Associated injuries such as nerve or tendon injuries
  • Secondary procedures at follow-up
  • Un-cooperated patients.

Sites / Locations

  • Pamukkale University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

surgical group

conservative group

Arm Description

distal radius fractures that treated volar plate

distal radius fractures that treated plaster of paris

Outcomes

Primary Outcome Measures

Visual Analogue Scale
To evaluate pain severity, patient show a point to indicate her/his pain between 0-10 points on a vertical 100mm line. Severity of pain was assessed with VAS in sleep, rest, and activity.
algometer
An algometer is used to evaluate pain threshold of the patient for distal radioulnar joint, ulnas styloid, m.pronator quadratus, radial styloid, m. flexor pollicis longus, and triangular fibrocartilage complex.The threshold value of pain was recorded by placing the probe against the points. Then, it was gradually increased and reduced to apply a pressure of 1kg / 0.5cm² with 0.5 cm² probe head .
range of motion
An universal goniometer is used to evaluate patient's active motion of joints for wrist and forearm.
grip strength
Grip strength was measured by a hand dynamometer according to the American Association of Hand Therapy Association's standard grip strength measurement method. Right/left extremity and their progression are compared in this evaluation.
radiographic evaluations
The posteroanterior (PA) and lateral (L) radiographic measurements were assessed by an experienced hand surgeon to determine the type of fracture, geometry, and associated pathology. Radial length and radial inclination were assessed by PA radiography. Dorsal or volar angulations of the distal fragment were evaluated on the lateral radiography.
Push-Off Test (POT)
POT was performed to determine the weight transfer strength of the patient to the injured extremity. The test was performed simultaneously and bilaterally by reversing the hand parts of the two hand dynamometers.
Michigan Hand Outcomes Questionnaire (MHOQ)
MHOQ was used for evaluating the participation and functional levels of the patients. In the questionnaire consisting of 37 questions under six headings, general hand function, daily life activities, pain, work, aesthetics and satisfaction are evaluated. In the pain scale, high scores indicate greater pain, while in the other five scales, high scores denote better hand performance.
Short Form of Disabilities of Arm-Shoulder and Hand Questionnaire (Q-DASH)
It was used to assess the upper extremity functional status of patients from their perspective. It is a questionnaire that measures an individual's ability to complete tasks, absorb forces, and severity of symptoms. It includes 11 item. The score on test ranges from 0 (no disability) to 100 (most severe disability). A higher scores indicate a greater level of disability and severity.
Jebsen-Taylor Hand Function Test (JTHFT)
The seven individual subtests of JTHFT writing, card turning, picking up small common objects, stacking checkers, stimulated feeding, moving light objects and moving heavy objects, were performed as a standardized procedure.

Secondary Outcome Measures

Full Information

First Posted
August 20, 2019
Last Updated
August 24, 2019
Sponsor
Pamukkale University
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1. Study Identification

Unique Protocol Identification Number
NCT04071002
Brief Title
Patients With Distal Radius Fracture
Official Title
Functional Status and Activity Participation Levels in Patients With Distal Radius Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 21, 2015 (Actual)
Primary Completion Date
June 9, 2016 (Actual)
Study Completion Date
September 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Surgically and conservatively treated distal radius fractures followed for six month. In this period 12 weeks rehabilitation programme applied for each group. Nine different evaluations were done in the initial, after physical therapy and 6th month. Results were presented.
Detailed Description
Distal radius fracture (DRF) affects overall health status. The International Classification of Function (ICF) based approach is appropriate in the management of DRF. The purpose of this study was to investigate functional status and activity participation levels of DRF patients. The patients were divided into conservative and surgical groups and were admitted to 12-weeks rehabilitation period. The evaluation of the body function and structure were done with Visual Analogue Scale, algometer, range of motion (ROM) and grip strength. Also, radiographic evaluations were done. Activity participation assessments were done with Push-Off Test (POT), Michigan Hand Outcomes Questionnaire (MHOQ), Short Form of Disabilities of Arm-Shoulder and Hand Questionnaire (Q-DASH) and Jebsen-Taylor Hand Function Test (JTHFT). Mann-Whitney U and Wilcoxon Tests were used respectively for intergroup and intra-group comparisons. Statistical significance level was p<0,05.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Disability
Keywords
Distal radius fracture, functional status, activity participation, hand therapy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
surgical group
Arm Type
Active Comparator
Arm Description
distal radius fractures that treated volar plate
Arm Title
conservative group
Arm Type
Active Comparator
Arm Description
distal radius fractures that treated plaster of paris
Intervention Type
Other
Intervention Name(s)
12 weeks physical therapy programme
Intervention Description
The programme include contrast bath, bandage, massage, active exercises, resistive exercises.
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
To evaluate pain severity, patient show a point to indicate her/his pain between 0-10 points on a vertical 100mm line. Severity of pain was assessed with VAS in sleep, rest, and activity.
Time Frame
six month
Title
algometer
Description
An algometer is used to evaluate pain threshold of the patient for distal radioulnar joint, ulnas styloid, m.pronator quadratus, radial styloid, m. flexor pollicis longus, and triangular fibrocartilage complex.The threshold value of pain was recorded by placing the probe against the points. Then, it was gradually increased and reduced to apply a pressure of 1kg / 0.5cm² with 0.5 cm² probe head .
Time Frame
six month
Title
range of motion
Description
An universal goniometer is used to evaluate patient's active motion of joints for wrist and forearm.
Time Frame
six month
Title
grip strength
Description
Grip strength was measured by a hand dynamometer according to the American Association of Hand Therapy Association's standard grip strength measurement method. Right/left extremity and their progression are compared in this evaluation.
Time Frame
six month
Title
radiographic evaluations
Description
The posteroanterior (PA) and lateral (L) radiographic measurements were assessed by an experienced hand surgeon to determine the type of fracture, geometry, and associated pathology. Radial length and radial inclination were assessed by PA radiography. Dorsal or volar angulations of the distal fragment were evaluated on the lateral radiography.
Time Frame
six month
Title
Push-Off Test (POT)
Description
POT was performed to determine the weight transfer strength of the patient to the injured extremity. The test was performed simultaneously and bilaterally by reversing the hand parts of the two hand dynamometers.
Time Frame
six month
Title
Michigan Hand Outcomes Questionnaire (MHOQ)
Description
MHOQ was used for evaluating the participation and functional levels of the patients. In the questionnaire consisting of 37 questions under six headings, general hand function, daily life activities, pain, work, aesthetics and satisfaction are evaluated. In the pain scale, high scores indicate greater pain, while in the other five scales, high scores denote better hand performance.
Time Frame
six month
Title
Short Form of Disabilities of Arm-Shoulder and Hand Questionnaire (Q-DASH)
Description
It was used to assess the upper extremity functional status of patients from their perspective. It is a questionnaire that measures an individual's ability to complete tasks, absorb forces, and severity of symptoms. It includes 11 item. The score on test ranges from 0 (no disability) to 100 (most severe disability). A higher scores indicate a greater level of disability and severity.
Time Frame
six month
Title
Jebsen-Taylor Hand Function Test (JTHFT)
Description
The seven individual subtests of JTHFT writing, card turning, picking up small common objects, stacking checkers, stimulated feeding, moving light objects and moving heavy objects, were performed as a standardized procedure.
Time Frame
six month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged between 18 and 60 Diagnosed with distal radius fracture Primary fixation after injury. Exclusion Criteria: Bilateral distal radius fracture Concomitant ulna styloid fracture Another orthopaedic, neurological or rheumatologic problem involving the ipsilateral upper limb Patients who underwent surgery that involved ipsilateral upper extremity Associated injuries such as nerve or tendon injuries Secondary procedures at follow-up Un-cooperated patients.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HANDE USTA, MSC
Organizational Affiliation
Pamukkale University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
ALI KITIS, PROF
Organizational Affiliation
Pamukkale University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
AHMET FAHIR DEMIRKAN, PROF
Organizational Affiliation
Pamukkale University
Official's Role
Study Director
Facility Information:
Facility Name
Pamukkale University
City
Denizli
State/Province
Kinikli
ZIP/Postal Code
20000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24508093
Citation
Valdes K, Naughton N, Michlovitz S. Therapist supervised clinic-based therapy versus instruction in a home program following distal radius fracture: a systematic review. J Hand Ther. 2014 Jul-Sep;27(3):165-73; quiz 174. doi: 10.1016/j.jht.2013.12.010. Epub 2014 Jan 3.
Results Reference
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Patients With Distal Radius Fracture

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