Patients With Distal Radius Fracture

Functional Status and Activity Participation Levels in Patients With Distal Radius Fracture

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.

Study Overview

• Status: Completed
• Conditions: Physical Disability
• Intervention / Treatment: Other: 12 weeks physical therapy programme

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.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kinikli
    • Denizli, Kinikli, Turkey, 20000
      • Pamukkale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: surgical group; distal radius fractures that treated volar plate	Other: 12 weeks physical therapy programme; The programme include contrast bath, bandage, massage, active exercises, resistive exercises.
ACTIVE_COMPARATOR: conservative group; distal radius fractures that treated plaster of paris	Other: 12 weeks physical therapy programme; The programme include contrast bath, bandage, massage, active exercises, resistive exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	six month
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 .	six month
range of motion	An universal goniometer is used to evaluate patient's active motion of joints for wrist and forearm.	six month
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.	six month
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.	six month
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.	six month
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.	six month
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.	six month
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.	six month

Collaborators and Investigators

• Sponsor: Pamukkale University
• Investigators: Principal Investigator: HANDE USTA, MSC, Pamukkale University; Study Director: AHMET FAHIR DEMIRKAN, PROF, Pamukkale University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 21, 2015
• Primary Completion (ACTUAL): June 9, 2016
• Study Completion (ACTUAL): September 1, 2016

Study Registration Dates

• First Submitted: August 20, 2019
• First Submitted That Met QC Criteria: August 24, 2019
• First Posted (ACTUAL): August 28, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 24, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: functional status; Distal radius fracture; hand therapy; activity participation
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Arm Injuries; Forearm Injuries; Radius Fractures
• Other Study ID Numbers: 3518

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No