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Trial registered on ANZCTR


Registration number
ACTRN12619000344190
Ethics application status
Approved
Date submitted
24/02/2019
Date registered
5/03/2019
Date last updated
13/11/2019
Date data sharing statement initially provided
5/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical effectiveness of ReHand Tablet solution for rehabilitation of wrist, hand and fingers trauma injuries and impact by reducing the economic burden
Scientific title
Clinical and economic effectiveness of ReHand Tablet solution for rehabilitation of wrist, hand and fingers trauma injuries and impact by reducing the economic burden, comparing ReHand as a home-based form of rehabilitation vs the home exercise program conventionally used in health insurance companies, evaluating its effects on hand clinical variables such as functionality and on resource management.
Secondary ID [1] 297515 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Distal radius fracture 311718 0
Ulna fracture 311760 0
Metacarpal fracture 311761 0
Phalangeal fracture 311762 0
Hand contusion 311763 0
Carpal fracture 311765 0
Tendon disorder of the hand 311766 0
Hand wound 311767 0
Hand luxation 311768 0
Hand sprain 311769 0
Condition category
Condition code
Physical Medicine / Rehabilitation 310338 310338 0 0
Occupational therapy
Physical Medicine / Rehabilitation 310339 310339 0 0
Other physical medicine / rehabilitation
Physical Medicine / Rehabilitation 310340 310340 0 0
Physiotherapy
Musculoskeletal 310341 310341 0 0
Other muscular and skeletal disorders
Injuries and Accidents 310342 310342 0 0
Fractures

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, in addition to the physiotherapy and occupational therapy sessions conventionally established by the health insurance company according to the pathology (standard care, no difference from control intervention).
Physioterapy and occupational therapy sessions are conducted by physiotherapists and occupational therapists from Ibermutua. The techniques used in these sessions were based on the clinical reasoning of these professionals, mainly using analgesic methods, manual therapy and motor control techniques. Sessions are held in Central Services of ibermutua and in Leganés centre. The number of sessions will be determined by the participant's recovery, starting with the participant's arrival at the rehabilitation department and ending with his or her discharge from work.
Physiotherapy and occupational therapy sessions, and home exercises through ReHand, are carried out throughout the rehabilitation process until the participant is discharged (days depending on the pathology).The home exercise program must be performed a minimum of 4 times a week. ReHand provides a battery of exercises that is configured according to the patient's pathology, so the exercise program is individualized according to pathology (e.g. the program for those participants with distal radius fracture was different from the program for methacarpal fracture patients) and lasted approximately 25 minutes per day (minimum 15 minutes, maximum 35 minutes). 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. Prior to each exercise there is a calibration to adapt it to the functional limitation of the patient. Thanks to the patient's contact with the tablet screen during exercise, the patient's activity can be monitored by the healthcare professional. ReHand intervention is only performed autonomously in the patient's home.
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] 313753 0
Rehabilitation
Intervention code [2] 313778 0
Treatment: Other
Comparator / control treatment
In the control condition subjects receive the home exercise program conventionally used, in addition to the physiotherapy and occupational therapy sessions conventionally established by the health insurance company according to the pathology. Physioterapy and occupational therapy sessions are conducted by physiotherapists and occupational therapists from Ibermutua. The techniques used in these sessions were based on the clinical reasoning of these professionals, mainly using analgesic methods, manual therapy and motor control techniques. Sessions are held in Central Services of ibermutua and in Leganés centre. The number of sessions will be determined by the participant's recovery, starting with the participant's arrival at the rehabilitation department and ending with his or her discharge from work. Physiotherapy and occupational therapy sessions, and home exercises are carried out throughout the rehabilitation process until the participant is discharged (days depending on the pathology). The home exercise program must be performed a minimum of 4 times a week. This program is individualized according to pathology and consists of a series of exercises configured by the physiotherapist or occupational therapist, and performed with a frequency of 12 to 15 repetitions per exercise, twice a day, with a total duration of 20-30 minutes. The adherence to treatment is monitored by asking participants if they had done the exercise program.
Exercise example: Wrist flexion and extension.
Control group
Active

Outcomes
Primary outcome [1] 319218 0
Number of days of temporary incapacity
Timepoint [1] 319218 0
At the time the participant is discharged from rehabilitation to return to work. Assessed by consulting the internal database of the health insurance company.
Secondary outcome [1] 367336 0
Self reported functional ability assessed using the Disabilities of the Arm, Shoulder and Hand questionnaire (DASH)
Timepoint [1] 367336 0
Every two weeks from the baseline measurement and at the time the participant is discharged from rehabilitation to return to work.
Secondary outcome [2] 367337 0
Grip strength assessed using a hydraulic grip dynamometer
Timepoint [2] 367337 0
Every two weeks from the baseline measurement and at the time the participant is discharged from rehabilitation to return to work.
Secondary outcome [3] 367338 0
Pinch strength assessed using a hydraulic pinch dynamometer
Timepoint [3] 367338 0
Every two weeks from the baseline measurement and at the time the participant is discharged from rehabilitation to return to work.
Secondary outcome [4] 367339 0
Self reported pain using a Visual Analog Scale of pain.
Timepoint [4] 367339 0
Every two weeks from the baseline measurement and at the time the participant is discharged from rehabilitation to return to work.
Secondary outcome [5] 367340 0
Dexterity assessed using the Nine Hole Peg Test
Timepoint [5] 367340 0
Every two weeks from the baseline measurement and at the time the participant is discharged from rehabilitation to return to work.
Secondary outcome [6] 367341 0
Number of physiotherapy sessions assessed through the internal database of IBERMUTUA
Timepoint [6] 367341 0
At the time the participant is discharged from rehabilitation to return to work.
Secondary outcome [7] 367342 0
Number of occupational therapy sessions assessed through the internal database of IBERMUTUA
Timepoint [7] 367342 0
At the time the participant is discharged from rehabilitation to return to work.
Secondary outcome [8] 367343 0
Number of rehabilitation visits assessed through the internal database of IBERMUTUA
Timepoint [8] 367343 0
At the time the participant is discharged from rehabilitation to return to work.
Secondary outcome [9] 367344 0
Number of plastic surgery visits assessed through the internal database of IBERMUTUA
Timepoint [9] 367344 0
At the time the participant is discharged from rehabilitation to return to work.
Secondary outcome [10] 367345 0
Number of control physician visits assessed through the internal database of IBERMUTUA
Timepoint [10] 367345 0
At the time the participant is discharged from rehabilitation to return to work.
Secondary outcome [11] 367346 0
Number of traumathology visits assessed through the internal database of IBERMUTUA
Timepoint [11] 367346 0
At the time the participant is discharged from rehabilitation to return to work.

Eligibility
Key inclusion criteria
Participants with a trauma pathology of wrist, hand and/or fingers that limits the functionality of the hand
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Mental health or cognitive problems that impede the patient's successful continuation of rehabilitative treatment
- Labor and/or legal problems (complaints to the company, request for change of job or change of contingency)
- Participants surgically reintervened

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" or at central administration 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
Not Applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Size= 112
The sample size has been established in such a way that it allows us to detect an effect that we have considered medium, between the means of duration of the temporary incapacity of both groups. We have set the type I error at 0.05. In our study, an effective sample of 102 subjects would be needed to detect this difference with a statistical power of 80%, with a value = 0.05 and a confidence level of 95%. Taking into account a loss rate of 10% (patients who drop out or are withdrawn from the study according to the established withdrawal criteria), the sample should be extended to 10 additional subjects, which means a total sample size of 112 subjects.

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).
Subsequently, a bivariate analysis will be carried out in which qualitative variables will be compared using contingency tables and Pearson's chi-square test, or Fisher's test (for tables in which there is at least an expected frequency of less than 5). To determine the existence of association between quantitative and qualitative variables, we will use the t-Student test or, if applicable, the Mann-Whitney U (non-parametric) if the qualitative variable is dichotomous or the ANOVA test or, if applicable, the Kuskal-Wallis test (non-parametric) if the qualitative variable is politomous (test for independent samples). To study the behaviour of two quantitative variables we will use techniques of
correlation analysis (Pearson or Spearman, according to their behaviour) and if the data allow it, multivariate study techniques will be carried out using regression techniques.
In order to compare the degree of improvement within each study group we will use repeated measurement tests such as the Student t test for related samples or, where appropriate, non-parametric tests for related samples according to the characteristics of the grouping variables. In case the results allow it, a subgroup analysis will be carried out according to the data obtained in the questionnaire carried out and valuing different grouping variables. We will use IBM SPSS Statistics 18 and EPIDAT 3.1 and 4.1; Significance levels below 0.05 (p<0.05) will be considered.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/03/2019
Actual
6/03/2019
Date of last participant enrolment
Anticipated
7/05/2019
Actual
4/04/2019
Date of last data collection
Anticipated
29/05/2019
Actual
15/07/2019
Sample size
Target
112
Accrual to date
Final
104
Recruitment outside Australia
Country [1] 21307 0
Spain
State/province [1] 21307 0
Madrid

Funding & Sponsors
Funding source category [1] 302074 0
Other
Name [1] 302074 0
Ibermutua
Country [1] 302074 0
Spain
Primary sponsor type
Other
Name
Ibermutua
Address
Ramírez de Arellano nº 27, 28043 Madrid, Madrid, España
Country
Spain
Secondary sponsor category [1] 301890 0
None
Name [1] 301890 0
None
Address [1] 301890 0
None
Country [1] 301890 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302754 0
Regional Research Ethics Committee with Medications of the Community of Madrid
Ethics committee address [1] 302754 0
Ethics committee country [1] 302754 0
Spain
Date submitted for ethics approval [1] 302754 0
03/04/2018
Approval date [1] 302754 0
10/04/2018
Ethics approval number [1] 302754 0
07/545711.9/18

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91282 0
Mrs Berta Pilar Corrales Serra
Address 91282 0
Ramírez de Arellano nº 27, 28043 Madrid, Madrid, España
Country 91282 0
Spain
Phone 91282 0
+34914163100
Fax 91282 0
Email 91282 0
[email protected]
Contact person for public queries
Name 91283 0
Jesús Blanquero Villar
Address 91283 0
Physiotherapy Department. University of Seville.
Avenzoar street, 6. 41009, Sevilla, Sevilla.
Country 91283 0
Spain
Phone 91283 0
+34954486528
Fax 91283 0
Email 91283 0
[email protected]
Contact person for scientific queries
Name 91284 0
Jesús Blanquero Villar
Address 91284 0
Physiotherapy Department. University of Seville.
Avenzoar street, 6. 41009, Sevilla, Sevilla.
Country 91284 0
Spain
Phone 91284 0
+34954486528
Fax 91284 0
Email 91284 0
[email protected]

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.