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Trial registered on ANZCTR


Registration number
ACTRN12618001887268
Ethics application status
Approved
Date submitted
14/11/2018
Date registered
20/11/2018
Date last updated
21/01/2019
Date data sharing statement initially provided
20/11/2018
Date results information initially provided
21/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of a sensorimotor-based Tablet app for rehabilitation after Carpal Tunnel Release
Scientific title
Efficacy of a sensorimotor-based Tablet app for rehabilitation after Carpal Tunnel Release on self reported functional ability, dexterity, grip strength and pain intensity.
Secondary ID [1] 296613 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carpal tunnel syndrome surgically intervened 310420 0
Condition category
Condition code
Physical Medicine / Rehabilitation 309133 309133 0 0
Other physical medicine / rehabilitation
Physical Medicine / Rehabilitation 309134 309134 0 0
Physiotherapy
Musculoskeletal 309135 309135 0 0
Other muscular and skeletal disorders

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 4-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 Carpal Tunnel Release 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: Pinch exercise with the index finger, performing a controlled movement in a painless range guided by feedback during 25 seconds.
Intervention code [1] 312918 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 4 weeks. The exercise program is the conventionally prescribed one by the public service for home rehabilitation after Carpal Tunnel Release 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: Contact each finger's pad with the thumb pad 15 times
Control group
Active

Outcomes
Primary outcome [1] 308117 0
Self reported functional ability assessed using the Disabilities of the Arm, Shoulder and Hand questionnaire (DASH)
Timepoint [1] 308117 0
At baseline and 4 weeks after the baseline measure
Secondary outcome [1] 353986 0
Dexterity assessed using the Nine Hole Peg Test
Timepoint [1] 353986 0
At baseline and 4 weeks after the baseline measure
Secondary outcome [2] 353987 0
Grip strength assessed using a hydraulic grip dynamometer
Timepoint [2] 353987 0
At baseline and 4 weeks after the baseline measure
Secondary outcome [3] 353988 0
Self reported pain using a Visual Analog Scale of pain
Timepoint [3] 353988 0
At baseline and 4 weeks after the baseline measure

Eligibility
Key inclusion criteria
-Subjects intervened of Carpal Tunnel Release 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
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Neurological pathology affecting 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 at baseline and 4 weeks post-baseline. 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
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21040 0
Spain
State/province [1] 21040 0
Seville

Funding & Sponsors
Funding source category [1] 301190 0
Government body
Name [1] 301190 0
Health Council of Andalusian Government
Address [1] 301190 0
Av. de la Innovación, 5, 41020 Sevilla
Country [1] 301190 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] 300813 0
None
Name [1] 300813 0
Address [1] 300813 0
Country [1] 300813 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301930 0
Ethics Committee of Virgen Macarena and Virgen del Rocío University Hospitals
Ethics committee address [1] 301930 0
Virgen del Rocío University Hospital. Avda. Manuel Siurot, S/n, 41013 Sevilla, Spain
Ethics committee country [1] 301930 0
Spain
Date submitted for ethics approval [1] 301930 0
Approval date [1] 301930 0
24/04/2017
Ethics approval number [1] 301930 0

Summary
Brief summary
Subjects sugically intervened of Carpal Tunnel Release are selected through consecutive sampling, concretely patients between the ages of 18 and 65, no more than 10 days after surgery. In the experimental condition subjects receive a sensorimotor-based Tablet app as a home-based form of rehabilitation, while in the control condition subjects receive the home exercise program on paper that is conventionally used in public hospital. The main hypothesis is that the use of ReHand is more effective than the conventional treatment used for home rehabilitation after Carpal Tunnel Release.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88598 0
Dr María Dolores Cortés Vega
Address 88598 0
Avenzoar Street, 6, 41009
Physiotherapy Department of University of Seville
Country 88598 0
Spain
Phone 88598 0
+34 954 55 14 71
Fax 88598 0
Email 88598 0
mdcortes@us.es
Contact person for public queries
Name 88599 0
Dr María Dolores Cortés Vega
Address 88599 0
Avenzoar Street, 6, 41009
Physiotherapy Department of University of Seville
Country 88599 0
Spain
Phone 88599 0
+34 954 55 14 71
Fax 88599 0
Email 88599 0
mdcortes@us.es
Contact person for scientific queries
Name 88600 0
Dr María Dolores Cortés Vega
Address 88600 0
Avenzoar Street, 6, 41009
Physiotherapy Department of University of Seville
Country 88600 0
Spain
Phone 88600 0
+34 954 55 14 71
Fax 88600 0
Email 88600 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 other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary