Clinical trial NCT04071002: Patients With Distal Radius Fracture
Official title: Functional Status and Activity Participation Levels in Patients With Distal Radius Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Disability
Keywords: Distal radius fracture
functional status
activity participation
hand therapy
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: six month
measure: algometer
timeFrame: six month
measure: range of motion
timeFrame: six month
measure: grip strength
timeFrame: six month
measure: radiographic evaluations
timeFrame: six month
measure: Push-Off Test (POT)
timeFrame: six month
measure: Michigan Hand Outcomes Questionnaire (MHOQ)
timeFrame: six month
measure: Short Form of Disabilities of Arm-Shoulder and Hand Questionnaire (Q-DASH)
timeFrame: six month
measure: Jebsen-Taylor Hand Function Test (JTHFT)
timeFrame: six month
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
state: Kinikli
Study officials:
affiliation: Pamukkale University
name: HANDE USTA, MSC
role: PRINCIPAL_INVESTIGATOR
affiliation: Pamukkale University
name: ALI KITIS, PROF
role: STUDY_CHAIR
affiliation: Pamukkale University
name: AHMET FAHIR DEMIRKAN, PROF
role: STUDY_DIRECTOR
References:
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.