Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000489190
Ethics application status
Approved
Date submitted
21/03/2019
Date registered
25/03/2019
Date last updated
3/04/2019
Date data sharing statement initially provided
25/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of a sensorimotor-based Tablet app for rehabilitation after distal radius fracture
Scientific title
Efficacy of a sensorimotor-based Tablet app for rehabilitation after distal radius fracture on wrist range of motion, joint position sense, self reported functional ability, dexterity, pinch and grip strength, pain intensity and on resource management.
Secondary ID [1] 297771 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Distal radius fracture 312114 0
Condition category
Condition code
Physical Medicine / Rehabilitation 310669 310669 0 0
Physiotherapy
Musculoskeletal 310670 310670 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 310671 310671 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the experimental condition subjects receive ReHand Tablet app as a home-based form of rehabilitation. A 6-week home exercise intervention is performed, which has to be carried out daily by the patient autonomously at home for at least 5 days per week, starting after baseline measurement, and beginning no more than 10 days after removal of immobilization or surgical intervention. The exercises of the Tablet app program are specifically selected for rehabilitation after distal radius fracture and last approximately 25 minutes per day. ReHand is a Tablet application (Android and iOS) which has a battery of specific exercises for the recovery after a trauma injury to be done touching the Tablet screen. The adherence to treatment is monitored through ReHand dashboard.
Exercise example: wrist flexion and extension, performing a controlled movement in a painless range guided by feedback during 25 seconds.
Intervention code [1] 314007 0
Rehabilitation
Comparator / control treatment
In the control condition subjects receive the home exercise program on paper that is conventionally used in public hospitals (not available resource yet) to be done daily during 6 weeks. The exercise program is the conventionally prescribed one by the public service for home rehabilitation after distal radius fracture and has a duration of 20-25 minutes. The exercises are focused on the mobility of the entire upper limb, with greater relevance of those exercises relating to the hand. The adherence to treatment is monitored through a weekly telephone call.
Exercise example: wrist flexion and extension for 15 times.
Control group
Active

Outcomes
Primary outcome [1] 319517 0
Self reported functional ability assessed by Patient Rated Wrist Evaluation (PRWE)
Timepoint [1] 319517 0
At baseline, 4 weeks, 3 months and 6 months after the baseline measure.
Secondary outcome [1] 368523 0
Dexterity assessed using the Nine Hole Peg Test
Timepoint [1] 368523 0
At baseline, 4 weeks, 3 months and 6 months after the baseline measure.
Secondary outcome [2] 368524 0
Grip strength assessed using a hydraulic grip dynamometer
Timepoint [2] 368524 0
At baseline, 4 weeks, 3 months and 6 months after the baseline measure.
Secondary outcome [3] 368525 0
Self reported pain using a Visual Analog Scale of pain
Timepoint [3] 368525 0
At baseline, 4 weeks, 3 months and 6 months after the baseline measure.
Secondary outcome [4] 368526 0
Sensorimotor evaluation of the wrist using the joint position sense test
Timepoint [4] 368526 0
At baseline, 4 weeks, 3 months and 6 months after the baseline measure.
Secondary outcome [5] 368527 0
Active wrist range of motion using a goniometer
Timepoint [5] 368527 0
At baseline, 4 weeks, 3 months and 6 months after the baseline measure.
Secondary outcome [6] 368528 0
Pinch strength assessed using a hydraulic pinch dynamometer
Timepoint [6] 368528 0
At baseline, 4 weeks, 3 months and 6 months after the baseline measure.
Secondary outcome [7] 368529 0
Quality of life assessed using the EQ-5D questionnaire
Timepoint [7] 368529 0
At baseline, 4 weeks, 3 months and 6 months after the baseline measure.
Secondary outcome [8] 368530 0
Return-to-work date reported by the patient
Timepoint [8] 368530 0
At baseline, 4 weeks, 3 months and 6 months after the baseline measure.
Secondary outcome [9] 368533 0
Number of physiotherapy sessions reported by the patient
Timepoint [9] 368533 0
At baseline, 4 weeks, 3 months and 6 months after the baseline measure.
Secondary outcome [10] 368534 0
Number of reinterventions (e.g. second surgery) reported by the patient
Timepoint [10] 368534 0
At baseline, 4 weeks, 3 months and 6 months after the baseline measure.
Secondary outcome [11] 368535 0
Number of consultations of rehabilitation reported by the patient
Timepoint [11] 368535 0
At baseline, 4 weeks, 3 months and 6 months after the baseline measure.
Secondary outcome [12] 368536 0
Travel costs reported by the patient calculated through the number of trips to health centres and the cost of each trip.
Timepoint [12] 368536 0
At baseline, 4 weeks, 3 months and 6 months after the baseline measure.
Secondary outcome [13] 368537 0
Number of emergency visits reported by the patient
Timepoint [13] 368537 0
At baseline, 4 weeks, 3 months and 6 months after the baseline measure.
Secondary outcome [14] 368538 0
Number of consultations to surgery service reported by the patient
Timepoint [14] 368538 0
At baseline, 4 weeks, 3 months and 6 months after the baseline measure.

Eligibility
Key inclusion criteria
- Subjects with distal radius fracture between the ages of 18 and 65
-No more than 10 days after surgery or removal of immobilisation
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Neurological pathology affecting the upper limb.
- Previous surgical process in the upper limb.
- Non-cooperative.
- Loss of cognitive capacity.
- Psychiatric illness

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involved contacting the holder of the allocation schedule who was "off-site"
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Number of participants needed=50 patients
Once the recorded data have been explored and refined, a descriptive statistical analysis will be carried out. The results derived from it will be expressed in number and percentage for the qualitative variables and centralisation measures (mean or median) and their corresponding dispersion measures (standard deviation or interquartile range) for the quantitative variables according to whether or not they follow a normal distribution (respectively).
Mean scores, standard deviations and within-group differences (95% CIs) will be calculated for all outcomes. The between-group differences and their respective 95% CIs will be calculated using linear mixed models by group, time and group-versus-time interaction terms. The confidence level adopted will be 5% .

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2019
Actual
1/04/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
1
Final
Recruitment outside Australia
Country [1] 21360 0
Spain
State/province [1] 21360 0
Seville

Funding & Sponsors
Funding source category [1] 302296 0
Government body
Name [1] 302296 0
Health Council of Andalusian Government
Country [1] 302296 0
Spain
Primary sponsor type
Charities/Societies/Foundations
Name
Andalusian Public Foundation for the Management of Health Research in Seville
Address
Hospital Universitario Virgen del Rocío. Avda. Manuel Siurot, s/n., Edif. de Laboratorios 6º planta., 41013 Sevilla
Country
Spain
Secondary sponsor category [1] 302171 0
None
Name [1] 302171 0
Address [1] 302171 0
Country [1] 302171 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302971 0
Ethics Committee of Virgen Macarena and Virgen del Rocío University Hospitals
Ethics committee address [1] 302971 0
Virgen del Rocío University Hospital. Avda. Manuel Siurot, S/n, 41013 Sevilla, Spain
Ethics committee country [1] 302971 0
Spain
Date submitted for ethics approval [1] 302971 0
Approval date [1] 302971 0
24/04/2017
Ethics approval number [1] 302971 0

Summary
Brief summary
Trauma surgery and rehabilitation services select patients with diagnosis of distal radius fracture to be enrolled througth consecutive sampling. This prospective clinical trial compared those who received ReHand app home exercise program with those enrolled in the conventional home exercise program guided by paper sheet. The main hypothesis is that the use of ReHand is more effective than the conventional treatment used for home rehabilitation of distal radius fracture.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92022 0
Dr María Dolores Cortés Vega
Address 92022 0
Avenzoar Street, 6, 41009 Physiotherapy Department of University of Seville
Country 92022 0
Spain
Phone 92022 0
+34 954 55 14 71
Fax 92022 0
Email 92022 0
mdcortes@us.es
Contact person for public queries
Name 92023 0
María Dolores Cortés Vega
Address 92023 0
Avenzoar Street, 6, 41009 Physiotherapy Department of University of Seville
Country 92023 0
Spain
Phone 92023 0
+34 954 55 14 71
Fax 92023 0
Email 92023 0
mdcortes@us.es
Contact person for scientific queries
Name 92024 0
María Dolores Cortés Vega
Address 92024 0
Avenzoar Street, 6, 41009 Physiotherapy Department of University of Seville
Country 92024 0
Spain
Phone 92024 0
+34 954 55 14 71
Fax 92024 0
Email 92024 0
mdcortes@us.es

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.