Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001796279
Ethics application status
Approved
Date submitted
27/10/2018
Date registered
5/11/2018
Date last updated
5/11/2018
Date data sharing statement initially provided
5/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of ReHand Tablet solution for rehabilitation after trauma conditions of hand, wrist and fingers.
Scientific title
Efficacy of ReHand Tablet solution for rehabilitation of trauma injuries of wrist, hand and fingers, comparing ReHand Tablet app as a home-based form of rehabilitation vs the home exercise program on paper that is conventionally used in public hospital, evaluating its effects on hand clinical variables such as functionality, and on resource management.
Secondary ID [1] 296444 0
None
Universal Trial Number (UTN)
Trial acronym
RRATC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Distal radius fracture 310214 0
5th metacarpal fracture 310215 0
Scaphoid fracture 310216 0
Carpal tunnel syndrome surgically intervened 310217 0
Rhizarthrosis surgically intervened 310218 0
Dupuytren surgically intervened 310219 0
Condition category
Condition code
Physical Medicine / Rehabilitation 308952 308952 0 0
Other physical medicine / rehabilitation
Injuries and Accidents 308984 308984 0 0
Fractures
Injuries and Accidents 308985 308985 0 0
Other injuries and accidents
Musculoskeletal 308986 308986 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 308988 308988 0 0
Occupational therapy
Physical Medicine / Rehabilitation 308989 308989 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the experimental condition subjects received ReHand Tablet app as a home-based form of rehabilitation. A 4-week home exercise intervention was performed, which had 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 exercise program was individualized according to pathology (e.g. the program for those patients with distal radius fracture was different from the program for carpal tunnel release patients) and lasted 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 was 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] 312770 0
Rehabilitation
Comparator / control treatment
In the control condition subjects received 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 was the conventionally prescribed one by the public service for all those pathologies and had a duration of 20-25 minutes. The exercises were focused on the mobility of the entire upper limb, with greater relevance of those exercises relating to the hand.
Exercise example: Contact each finger's pad with the thumb pad 15 times
Control group
Active

Outcomes
Primary outcome [1] 307917 0
Self reported functional ability assessed using the Disabilities of the Arm, Shoulder and Hand questionnaire (DASH)
Timepoint [1] 307917 0
4 [primary timepoint], 12, 24 weeks after the baseline measure.
Secondary outcome [1] 353338 0
Grip strength assessed using a hydraulic grip dynamometer
Timepoint [1] 353338 0
4, 12 and 24 weeks after the baseline measure
Secondary outcome [2] 353339 0
Pinch strength assessed using a hydraulic pinch dynamometer
Timepoint [2] 353339 0
4, 12 and 24 weeks after the baseline measure
Secondary outcome [3] 353340 0
Self reported pain using a Visual Analog Scale of pain
Timepoint [3] 353340 0
4, 12 and 24 weeks after the baseline measure
Secondary outcome [4] 353341 0
Dexterity assessed using the Nine Hole Peg Test
Timepoint [4] 353341 0
4, 12 and 24 weeks after the baseline measure
Secondary outcome [5] 353342 0
Wrist range of movement using a goniometer
Timepoint [5] 353342 0
4, 12 and 24 weeks after the baseline measure
Secondary outcome [6] 353343 0
Quality of life assessed using the EQ-5D questionnaire
Timepoint [6] 353343 0
4, 12 and 24 weeks after the baseline measure
Secondary outcome [7] 353344 0
Names and number of drugs related to the pathology reported by the patient
Timepoint [7] 353344 0
24 weeks after the baseline measure
Secondary outcome [8] 353345 0
Return-to-work date reported by the patient
Timepoint [8] 353345 0
24 weeks after the baseline measure
Secondary outcome [9] 353346 0
Number of physiotherapy sessions reported by the patient
Timepoint [9] 353346 0
24 weeks after the baseline measure
Secondary outcome [10] 353347 0
Number of reinterventions (e.g. second surgery) reported by the patient
Timepoint [10] 353347 0
24 weeks after the baseline measure
Secondary outcome [11] 353348 0
Number of consultations of rehabilitation reported by the patient
Timepoint [11] 353348 0
24 weeks after the baseline measure
Secondary outcome [12] 353349 0
Travel costs reported by the patient calculated through the number of trips to health centres and the cost of each trip.
Timepoint [12] 353349 0
24 weeks after the baseline measure
Secondary outcome [13] 353350 0
Number of emergency visits reported by the patient
Timepoint [13] 353350 0
24 weeks after the baseline measure

Eligibility
Key inclusion criteria
-Subjects over 18 years of age.
-Pathology of wrist, hand and fingers of the following: distal radius fracture, 5th metacarpal fracture, carpal bone fracture, carpal tunnel syndrome surgically intervened, rhizarthrosis surgically intervened, Dupuytren surgically intervened.
-No more than 10 days after surgery or removal of immobilisation
Minimum age
18 Years
Maximum age
No limit
Sex
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
Size= 660 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).
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
Recruiting
Date of first participant enrolment
Anticipated
Actual
25/04/2017
Date of last participant enrolment
Anticipated
30/04/2019
Actual
Date of last data collection
Anticipated
24/10/2019
Actual
Sample size
Target
660
Accrual to date
395
Final
Recruitment outside Australia
Country [1] 20977 0
Spain
State/province [1] 20977 0
Seville

Funding & Sponsors
Funding source category [1] 301041 0
Government body
Name [1] 301041 0
Health Council of Andalusian Government
Country [1] 301041 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] 300638 0
None
Name [1] 300638 0
Address [1] 300638 0
Country [1] 300638 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301796 0
Ethics Committee of the University Hospitals Virgen Macarena and Virgen del Rocío
Ethics committee address [1] 301796 0
University Hospitals Virgen Macarena and Virgen del Rocío
Ethics committee country [1] 301796 0
Spain
Date submitted for ethics approval [1] 301796 0
Approval date [1] 301796 0
24/04/2017
Ethics approval number [1] 301796 0
0446-N-17

Summary
Brief summary
Traumatological injuries of the wrist, hand and fingers are one of the most common and one of the costliest. According to scientific evidence, program exercises are effective for the rehabilitation of this segment. However, the format of prescribing exercises on paper is inefficient, having a need for updating. ReHand is a Tablet application (Android and iOS) developed under the guidelines of various healthcare professionals (rehabilitators, hand surgeons, physiotherapists and occupational therapists) to enhance, through controlled active work, the dexterity and functionality of the wrist, hand and finger segment after a trauma injury. Subjects are selected through consecutive sampling, concretely patients over 18 years of age, no more than 10 days after surgery or removal of immobilization, with any of the following pathologies: distal radius fracture, 5th metacarpal fracture, carpal bone fracture, carpal tunnel syndrome surgically intervened, rhizarthrosis surgically intervened, and Dupuytren surgically intervened. In the experimental condition subjects received ReHand Tablet app as a home-based form of rehabilitation, while in the control condition subjects received 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 these conditions. This is a multicenter study carried out in Virgen del Rocío and Virgen Macarena hospitals, and in San Juan de Dios Aljarafe Hospital. The overall trial start date was 25/04/2017 and the recruitment is expected to continue until 30/04/2019. During this time, results could be published. This study was supported by the Innovation Projects Grant #0143-2017 of the Health Council of Andalusian Government.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88134 0
Dr María Dolores Cortés Vega
Address 88134 0
Avenzoar Street, 6, 41009
Physiotherapy Department of University of Seville
Country 88134 0
Spain
Phone 88134 0
+34 954 55 14 71
Fax 88134 0
Email 88134 0
[email protected]
Contact person for public queries
Name 88135 0
Dr María Dolores Cortés Vega
Address 88135 0
Avenzoar Street, 6, 41009
Physiotherapy Department of University of Seville
Country 88135 0
Spain
Phone 88135 0
+34 954 55 14 71
Fax 88135 0
Email 88135 0
[email protected]
Contact person for scientific queries
Name 88136 0
Dr María Dolores Cortés Vega
Address 88136 0
Avenzoar Street, 6, 41009
Physiotherapy Department of University of Seville
Country 88136 0
Spain
Phone 88136 0
+34 954 55 14 71
Fax 88136 0
Email 88136 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.