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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: REBEC
Last refreshed on: 29 May 2023
Main ID:  RBR-75h3nz
Date of registration: 06/02/2018
Prospective Registration: No
Primary sponsor: Universidad de las Americas
Public title: Effects of scapula exercises in patients with Fracture of the distal radius
Scientific title: Effectiveness of adding scapular control exercises to kinetic treatment in patients with distal radius fracture: Randomized simple-blind clinical study - : RCT
Date of first enrolment: 01/01/2018
Target sample size:
Recruitment status: Data analysis completed
URL:  http://ensaiosclinicos.gov.br/rg/RBR-75h3nz
Study type:  Intervention
Study design:  Clinical trial of treatment, randomized-controlled, parallel, single blind, two arms.  
Phase:  N/A
Countries of recruitment
Chile
Contacts
Name: Felipe Andres   Araya
Address:  Manuel Montt 948 7500972 Santiago Chile
Telephone: +5697122483
Email: fandres.kine@gmail.com
Affiliation:  Universidad de las Americas
Name: Felipe Andres   Araya
Address:  Manuel Montt 948 7500972 Santiago Chile
Telephone: +5697122483
Email: fandres.kine@gmail.com
Affiliation:  Universidad de las Americas
Key inclusion & exclusion criteria
Inclusion criteria: subjects over 60 years of age derived from the Adult Traumatology Service of the San Borja Arriarán Clinical Hospital, with a medical diagnosis of multifrectional extraarticular type FRD according to the AO classification, treated conservatively with closed reduction plus immobilization with plaster. Subjects that accept and sign informed consent.
Exclusion criteria: Subjects presenting some immediate complication after removal of immobilization , painful regional complex type I, carpal tunnel syndrome, etc. subjects presenting a shoulder pathology diagnosed at least 1 year before the occurrence of the DRF, subacromial pinching syndrome, partial or total rupture of the rotator cuff, glenohumeral instability, adhesive capsulitis, etc.


Age minimum:
Age maximum:
Gender: -
Health Condition(s) or Problem(s) studied
M84.4
distal epiphysis radius fracture
Intervention(s)
E02.779.474
Other
The control group will have 51 patients and will receive a kinesic treatment program, this consists of 15 minutes of active wrist and hand exercises in EESS turbidity at a temperature of 34ºc; then apply joint mobilization in the radio-carpal joint, in the first two weeks will be performed oscillatory techniques according to Maitland , in the remaining weeks will be performed sliding techniques sustained according to Kaltenborn, with the radius stabilized in neutral position, the technique will be carried out in antero-posterior and postero-anterior direction with 1 minute of maintenance. Finally, exercises are prescribed based on a graduated corticomotor retraining approach, incorporating the regulated reacquisition of specific motor skills in order to reorganize cortical plasticity and achieve motor learning. Two specific exercises will be carried out; the exercise of graduated grip grip control with a biofeedback of visual pressurization; the exercise of graduated control of the inverted dart with precision of the first interosseous space. Based on the premise of avoiding muscle pain and fatigue, a job of low load and short duration will be requested, the dose will be of 8 to 10 repetitions for each exercise, with 5 seconds of maintenance of the task and 10 to 30 seconds. of rest between repetitions. There will be 12 sessions in total from the program, with a periodicity of 2 to 3 times per week with a duration of approximately one hour per session.
The experimental group will have 51 patients and they will receive the same treatment program as the control group, but a pattern of scapular control exercises will also be added, this consists of 3 specific exercises whose purpose will be to improve dysfunctional scapular kinematics. It begins with an exercise of co
Primary Outcome(s)
When comparing the results between both treatments at the end of week 6, the DASH questionnaire showed a difference of 16.7 points (p = 0.000), the wrist function with PRWE showed a difference of 1.5 points (p = 0.541).
functionality

To assess the functionality prior to the start of treatment and at the end of the treatment, the DASH questionnaire will be used. The sample size was calculated using the Stata 12.0 program, and the necessary initial data was extracted from the study conducted by Gong et al. Patients with FRD treated with immobilization with gypsum plus a kinesic treatment program, at the sixth week showed an average of 50.7 with a Standard Deviation (SD) of 24.4 points in the DASH questionnaire. Taking into account the study by Franchignoni et al, we established as a minimum clinically important difference a reduction of at least 15 points for the experimental group compared to the control. To detect this difference between both treatments, with a value of P = 0.05 (probability of committing a type I error) and a statistical power of 80%, a minimum of 42 patients per group is needed, we also consider adjusting the size of the shows for possible losses, for that we will recruit 20% more of the required patients in each group. According to this, the authors of the present study have proposed as experimental hypothesis that there is a reduction of at least 15 points in the DASH questionnaire in the group treated with scapular control exercises added to the kinesic treatment compared with the group that received only kinesic treatment .



As positive results, we expect there to be significant differences between EG and GG in the final year of a 12-week treatment program.
Secondary Outcome(s)
When comparing the results between both treatments at the end of week 6, the movement pain measured with EVA showed a decrease of 1.7 cm (P = 0.000)
wrist functionality

To assess the wrist functionality prior to treatment and after treatment, the PRWE validated questionnaire will be used, an increase in its score is expected at the end of the treatment
Pain

To evaluate the pain intensity prior to treatment and after treatment, the analogous visual scale (VAS) will be used, expecting a decrease after the intervention.
Secondary ID(s)
Source(s) of Monetary Support
CDT Hospital San Borja de Arriaran
Secondary Sponsor(s)
CDT Hospital San Borja de Arriaran
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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