Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001912279
Ethics application status
Approved
Date submitted
21/11/2018
Date registered
23/11/2018
Date last updated
23/11/2018
Date data sharing statement initially provided
23/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the effectiveness of a home based telerehabilitation model for the delivery of Physiotherapy Exercise Programs following Burn Injury
Scientific title
Evaluating the effectiveness of a home based telerehabilitation model for the delivery of Physiotherapy Exercise Programs following Burn Injury
Secondary ID [1] 296676 0
Nil Known
Universal Trial Number (UTN)
U1111-1224-3956
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Burns 310524 0
Condition category
Condition code
Injuries and Accidents 309236 309236 0 0
Burns
Physical Medicine / Rehabilitation 309252 309252 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will consist of a Physiotherapy exercise program conducted using a telerehabilitation medium after discharge from a hospital admission for a burn injury. Participants in this group will be provided with a home exercise program to continue independently 3 to 5 times per day. Exercise sheets are provided that are individualised per participant based on location of burn injury and the functional level of the participant eg burn to posterior calf, calf stretches prescribed. An exercise DVD entitled “Stretching your limits” will also be provided. This DVD was produced by the RBWH Burn unit and is available free of charge to patients but is available for purchase to external parties through Queensland Health. In addition to this, participants will be provided with a maximum of up to two (2) Telerehabilitation link up sessions per week into the patient’s home conducted by a Burns trained Physiotherapist. The Telerehabilitation sessions will include the provision of an appropriate exercise program consisting of burn specific stretching and strengthening exercises which will be tailormade for the participant based on the location of the burn and the functional level of the participant. The participant will also receive appropriate education and advice. The telerehabilitation sessions will be 60 minutes in duration. The participant will continue this exercise program for a six (6) week period.
The Telerehabilitation intervention will utilise eHAB® (NeoRehab, Brisbane, Australia), a clinically validated telerehabilitation system whose software platform allows multi-point groups and individual assessments. eHAB has been previously validated for limb measurements and ROM in musculoskeletal assessments. A telehealth administration officer will complete a test call to trouble shoot problems with the device or any software or internet connection issues prior to the initial patient interaction. After each Telerehabilitation link up, the Burn Physiotherapist will send an email to the patient with a summary of the treatment plan and any additional aids to encourage the ongoing home exercise program. The participants are required to keep a home exercise diary to highlight how often per day they complete their exercise program.
Intervention code [1] 312992 0
Rehabilitation
Intervention code [2] 312993 0
Treatment: Other
Comparator / control treatment
Participants in this group will be provided with a home exercise program to continue independently 3 to 5 times per day. Exercise sheets are provided that are individualised per participant based on location of burn injury and the functional level of the participant eg burn to posterior calf, calf stretches prescribed. An exercise DVD entitled “Stretching your limits” will also be provided. This DVD was produced by the RBWH Burn unit and is available free of charge to patients but is available for purchase to external parties through Queensland Health. In addition to this, the patient will be provided with a maximum of up to two (2) face to face Outpatient Physiotherapy sessions per week with either a Burn Physiotherapist at the RBWH (Control subgroup 1) or with a Physiotherapist in their home or regional location (Control subgroup 2) The face to face outpatient Physiotherapy sessions will include the provision of an appropriate exercise program consisting of burn specific stretching and strengthening exercises which will be tailormade for the participant based on the location of the burn and the functional level of the participant. The participant will also receive appropriate education and advice. The face to face sessions will be a maximum of 60 minutes in duration. The participant will continue this exercise program for a six (6) week period. The participants are required to keep a home exercise diary to highlight how often per day they complete their exercise program.
Control group
Active

Outcomes
Primary outcome [1] 308204 0
Burn Specific Health Scale–Brief - Health related quality of life measure
Timepoint [1] 308204 0
Prior to intervention commencement and then 6 weeks (primary endpoint) and 12 weeks post commencement of intervention
Primary outcome [2] 308205 0
Range of Motion will be measured only of joints underlying the burn area of the participant. This will be assessed with a goniometer
Timepoint [2] 308205 0
Prior to intervention commencement and then 6 weeks (primary endpoint) and 12 weeks post commencement of intervention
Primary outcome [3] 308206 0
Muscle Strength - Grip Strength. Measured using a Jamar dynamometer
Timepoint [3] 308206 0
Prior to intervention commencement and then 6 weeks (primary endpoint) and 12 weeks post commencement of intervention
Secondary outcome [1] 354228 0
Pain score using the Numerical rating scale (NRS)
Timepoint [1] 354228 0
Prior to intervention commencement and then 6 weeks and 12 weeks post commencement of intervention
Secondary outcome [2] 354229 0
AQoL-4D - Assessment of Quality of Life (General Scale)
Timepoint [2] 354229 0
Prior to intervention commencement and then 6 weeks and 12 weeks post commencement of intervention
Secondary outcome [3] 354230 0
Brisbane Burn Scar Impact Profile (BBSIP) - scar assessment scale
Timepoint [3] 354230 0
Prior to intervention commencement and then 6 weeks and 12 weeks post commencement of intervention
Secondary outcome [4] 354231 0
Self Efficacy for exercise scale
Timepoint [4] 354231 0
Prior to intervention commencement and then 6 weeks and 12 weeks post commencement of intervention
Secondary outcome [5] 354232 0
Patient Satisfaction Questionnaire

This questionnaire has been designed specifically for the Telehealth study we are undertaking and has not been validated.
Timepoint [5] 354232 0
At 6 weeks post commencement of intervention
Secondary outcome [6] 354233 0
Patient Cost analysis diary - to document travel expenses, parking, child care etc related to Physiotherapy appointments
Timepoint [6] 354233 0
At 6 weeks post commencement of intervention
Secondary outcome [7] 354234 0
Therapist Satisfaction survey with Telerehabilitation encounter. This survey asks the therapist about issues such as technical issues, visual or auditory failures encountered with the telehealth system and was designed specifically for this study
Timepoint [7] 354234 0
At the completion of each Telerehabilitation encounter
Secondary outcome [8] 354304 0
Quadriceps Isometric Muscle Strength - measured using a hand held dynamometer (Commander Muscle Tester, JTech, USA)

Please note this is a primary outcome measure
Timepoint [8] 354304 0
Prior to intervention commencement and then 6 weeks (primary endpoint) and 12 weeks post commencement of intervention

Eligibility
Key inclusion criteria
Patients eligible for inclusion in this study will be
• Male or Female
• Age > 18 years
• Admitted to the Professor Stuart Pegg Adult Burn Unit, RBWH with a total body surface area burn injury (%TBSA) of < 25%.
• Depth of Burn injury is Partial or Full thickness burn ie requiring > 14 days to heal conservatively or required a split skin graft for healing.
• Area of Burn is over a joint or includes the face, neck or trunk and requires Physiotherapy intervention for contracture prevention and management
• Has access to an internet-enabled computer, tablet or mobile device with web camera / video streaming capability within their own home
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients for whom English is not their primary language and would require an accredited interpreter

Patients with significant visual, hearing, language or cognitive deficits

Patients with concomitant medical conditions that may prevent them from safely completing an exercise program and that may influence the rehabilitation process eg recent myocardial infarction, severe pulmonary disease, concomitant musculoskeletal or neurological conditions

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 will be concealed through the use of opaque, sealed envelopes and will be administered by an independent researcher who is separated at a distance from the clinicians providing the physiotherapy exercise programs in each group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by randomly selecting a sealed envelope from a container
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
Our sample size would be based on the main outcome measure BSHB-B. In a study conducted by our group previously, we found an effect size of 0.81. Aiming for power > 80%, significance level of < 0.05 (corrected to p<0.016 for three intervention groups) it was calculated that 46 patients are required in each group in order to avoid a Type I error. We will increase this to 50 patients per group to allow for drop outs or missing data, therefore 150 patients will be recruited overall.

Analysis would initially consist of a baseline comparison for age, co-morbidities, %TBSA, hospital length of stay, inhalation injury and highest education level. The outcome measures (BSHS-B) would then be tested for normality and if shown to have normal distribution, parametric statistics would be utilized to analyse group by time interactions of the three cohorts, as well as within-group changes over time. Continuous variables would be analysed by a between/within repeated measures ANOVA and categorical variables by an extended chi-square.

Patient satisfaction rates with Telerehabilitation will be compared with Standard Outpatient Physiotherapy Care using appropriate comparative and descriptive statistics including medians, means and percentages. Similar methods will be used for comparison of therapist satisfaction rates with Telerehabilitation versus Standard Outpatient Physiotherapy Care. Telerehabilitation connectivity issues will be described using appropriate descriptive statistics. Patient costs will be calculated from the costs analysis diary and will inform any cost savings to the patient that may be realised by providing the Telerehabilitation service.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/01/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 12491 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 24870 0
4029 - Royal Brisbane Hospital

Funding & Sponsors
Funding source category [1] 301255 0
Hospital
Name [1] 301255 0
Royal Brisbane and Women's Hospital, Physiotherapy Department Research Funding
Country [1] 301255 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital, Physiotherapy Department
Address
Physiotherapy Department
Level 2 Ned Hanlon Building
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 300898 0
None
Name [1] 300898 0
Address [1] 300898 0
Country [1] 300898 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301996 0
Human Research Ethics Committee, Royal Brisbane and Women's Hospital
Ethics committee address [1] 301996 0
Executive Administration Lower Ground Floor
Dr James Mayne Building
Royal Brisbane and Women's Hospital Campus
Herston QLD 4029
Ethics committee country [1] 301996 0
Australia
Date submitted for ethics approval [1] 301996 0
27/08/2018
Approval date [1] 301996 0
15/10/2018
Ethics approval number [1] 301996 0
HREC/2018/QRBW/45588

Summary
Brief summary
The aim of this research is to ascertain whether physiotherapy exercise programs provided via Telerehabilitation are as effective as current standard face to face outpatient physiotherapy exercise programs with respect to clinical outcomes for patients with burn injuries post hospital admission.

Males or Females aged 18 years or greater who are admitted to the Professor Stuart Pegg Adult Burn Unit, RBWH with a total body surface area partial or full thickness burn injury (%TBSA) of < 25% are eligible for this study. Participants must have access to an internet-enabled computer, tablet or mobile device with web camera / video streaming capability within their own home

Study Details - Baseline outcome measures will be collected at discharge from hospital and then the participant will then be randomised to either the Telerehabilitation Physiotherapy group or the Standard Care Outpatient Physiotherapy group. Each of the groups will receive a burn specific physiotherapy exercise program over a 6 week period but the Telerehabilitation group will receive this exercise training using the ehab telehealth system delivered via the internet into their own home and the standard care groups will receive their exercise programs via a face to face outpatient appointment. All groups will be expected to continue an independent home exercise program.

Outcome measures will be collected at baseline, 6 weeks and 12 weeks post baseline. These measures will include health related quality of life, range of motion, muscle strength, pain, scar assessment and self efficacy for exercise. Information will also be collected on both participant and therapist satisfaction with the telerehabilitation service. It is hoped that telerehabilitation will prove a viable alternative method for the delivery of exercise programs after burn injury.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88798 0
Ms Anita Plaza
Address 88798 0
Physiotherapy Department
Level 2 Ned Hanlon Building
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Country 88798 0
Australia
Phone 88798 0
+61 7 36464319
Fax 88798 0
Email 88798 0
[email protected]
Contact person for public queries
Name 88799 0
Ms Anita Plaza
Address 88799 0
Physiotherapy Department
Level 2 Ned Hanlon Building
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Country 88799 0
Australia
Phone 88799 0
+61 7 36464319
Fax 88799 0
Email 88799 0
[email protected]
Contact person for scientific queries
Name 88800 0
Ms Anita Plaza
Address 88800 0
Physiotherapy Department
Level 2 Ned Hanlon Building
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Country 88800 0
Australia
Phone 88800 0
+61 7 36464319
Fax 88800 0
Email 88800 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.