Patients With Distal Radius Fracture

NCT ID: NCT04071002

Last Updated: 2019-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-21

Study Completion Date

2016-09-01

Brief Summary

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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

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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.

Conditions

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Physical Disability

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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surgical group

distal radius fractures that treated volar plate

Group Type ACTIVE_COMPARATOR

12 weeks physical therapy programme

Intervention Type OTHER

The programme include contrast bath, bandage, massage, active exercises, resistive exercises.

conservative group

distal radius fractures that treated plaster of paris

Group Type ACTIVE_COMPARATOR

12 weeks physical therapy programme

Intervention Type OTHER

The programme include contrast bath, bandage, massage, active exercises, resistive exercises.

Interventions

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12 weeks physical therapy programme

The programme include contrast bath, bandage, massage, active exercises, resistive exercises.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pamukkale University

OTHER

Sponsor Role lead

Responsible Party

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HANDE USTA

Principal Investigator, Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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HANDE USTA, MSC

Role: PRINCIPAL_INVESTIGATOR

Pamukkale University

ALI KITIS, PROF

Role: STUDY_CHAIR

Pamukkale University

AHMET FAHIR DEMIRKAN, PROF

Role: STUDY_DIRECTOR

Pamukkale University

Locations

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Pamukkale University

Denizli, Kinikli, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 24508093 (View on PubMed)

Other Identifiers

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3518

Identifier Type: -

Identifier Source: org_study_id

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