Effects of Early Manual Therapy on Functional Outcomes After Volar Plating of Distal Radius Fractures
1 other identifier
interventional
32
1 country
1
Brief Summary
The aim of the study was to investigate the effects of early manual therapy on function, pain, range of motion (ROM), hand and pinch grip strength and disability level in patients underwent volar plating after distal radius fracture (DRF). Patients were randomly divided into two groups: Routin Physiotherapy (RP) or Early Manual Therapy (EMT). While RP group received routine physiotherapy, EMT group received routine physiotherapy plus Mulligan's Mobilization With Movement technique. All treatments were done two sessions a week, through 12 weeks. Function, pain, range of motion (ROM), hand and pinch grip strength and disability level of patients were assessed. Measurements were made at postoperative week 3, 6 and 12.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedFirst Submitted
Initial submission to the registry
July 26, 2018
CompletedFirst Posted
Study publicly available on registry
August 3, 2018
CompletedNovember 14, 2018
November 1, 2018
2.6 years
July 26, 2018
November 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change in the function
Function was asssesed by using Patient Rated Wrist Evaluation (PRWE)
postoperative week 6, 12.
Secondary Outcomes (4)
change in the severity of pain
postoperative day 1, postoperative week 3, 6, 12.
change in the range of motion (ROM)
postoperative week 3, 6, 12.
change in hand and pinch grip strength
postoperative week 3, 6, 12.
change in disability
postoperative week 6, 12.
Study Arms (2)
Early Manual Therapy Group
EXPERIMENTALRoutine physiotherapy program plus Mulligan's Mobilization with Movement technique were applied.
Routine Physiotherapy Group
ACTIVE COMPARATOROnly routine physiotherapy program was applied
Interventions
Mulligan's Mobilization with Movement technique for radiocarpal,ulnocarpal, distal radioulnar and proximal radioulnar joints was applied.
Routine physiotherapy program consisted of range of motion, flexibility and strengthening exercises, and home exercise program was applied.
Eligibility Criteria
You may qualify if:
- An age of eighteen years or older
- An unstable fracture of the distal end of the radius
- Fixation with a volar locking plate
- Able to read, write, and understand Turkish
- Willing and able to attend the study
You may not qualify if:
- Previous fracture on the injured side
- Concurrent fracture in contralateral upper extremity
- Accompanied bony and soft tissue injuries other than radius fracture
- Inflammatory joint diseases, metabolic diseases and neurological diseases
- Mental and cognitive disorders that would seriously affect cooperation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dokuz Eylul University
Izmir, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
July 26, 2018
First Posted
August 3, 2018
Study Start
September 1, 2015
Primary Completion
April 1, 2018
Study Completion
May 1, 2018
Last Updated
November 14, 2018
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share