Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000610730
Ethics application status
Approved
Date submitted
20/05/2013
Date registered
28/05/2013
Date last updated
26/06/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of immediate feedback through video and computer-based interactive exercises on physical mobility in geriatric and neurological rehabilitation
Scientific title
Immediate feedback through video and computer-based interactive exercises for geriatric and neurological rehabilitation
Secondary ID [1] 282320 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mobility impairment in aged care and neurological rehabilitation 288863 0
Condition category
Condition code
Physical Medicine / Rehabilitation 289206 289206 0 0
Other physical medicine / rehabilitation
Neurological 289538 289538 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Video and computer-based interactive exercises that aim to enhance mobility through immediate feedback. Exercise sessions take place in addition to usual care under supervision of a physiotherapist, five times a week, one hour per day. The additional exercise sessions start upon hospital admission and enrolment in the study and continue till discharge. The daily time participants spend in usual therapy will be monitored. In addition, adherence and therapy content of the additional therapy sessions are monitored by keeping a therapy diary.
Intervention code [1] 286935 0
Rehabilitation
Comparator / control treatment
Usual rehabilitation care: interdisciplinary rehabilitation following the standards outlined by the clinical guidelines for stroke management
Control group
Active

Outcomes
Primary outcome [1] 289318 0
Short Physical Performance Battery - continuous summary score.
Timepoint [1] 289318 0
week 2
Secondary outcome [1] 302231 0
Short Physical Performance Battery - ordinal summary score
Timepoint [1] 302231 0
week 2
Secondary outcome [2] 302901 0
Between group comparison of change in Short Physical Performance Battery score as reflected by the number of patients reaching minimal clinically important difference (MCID)
Timepoint [2] 302901 0
week 2
Secondary outcome [3] 302902 0
10-m Timed Walk
Timepoint [3] 302902 0
week 2
Secondary outcome [4] 302903 0
Temporal and Spatial Gait Parameters as measured with Gaitrite
Timepoint [4] 302903 0
week 2
Secondary outcome [5] 302904 0
2-min Walk Test
Timepoint [5] 302904 0
week 2
Secondary outcome [6] 302905 0
Maximal Balance Range
Timepoint [6] 302905 0
week 2
Secondary outcome [7] 302906 0
Step Test
Timepoint [7] 302906 0
week 2
Secondary outcome [8] 302907 0
Rivermead Mobility Index
Timepoint [8] 302907 0
week 2, 6 and 12
Secondary outcome [9] 302908 0
Activity Measure Post Acute Care
Timepoint [9] 302908 0
week 2, 6 and 12
Secondary outcome [10] 302909 0
Reintegration to Normal Living Index
Timepoint [10] 302909 0
week 2, 6 and 12
Secondary outcome [11] 302910 0
EuroQol-5D
Timepoint [11] 302910 0
week 2, 6 and 12
Secondary outcome [12] 302911 0
Falls Efficacy Scale
Timepoint [12] 302911 0
week 2, 6 and 12
Secondary outcome [13] 302912 0
Number of falls recorded in falls diary
Timepoint [13] 302912 0
week 2, 6 and 12
Secondary outcome [14] 302978 0
Health and community service use recorded in diary
Timepoint [14] 302978 0
week 2, 6 and 12

Eligibility
Key inclusion criteria
Reduced mobility (SPPB < 12)
Therapist-assessed capacity for improvement in mobility
Therapist considers the intervention appropriate
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Marked cognitive impairment
Medical condition precluding exercise
Lack of interest
Inability to balance in standing despite assistance of a therapist or walking aid

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation

Randomisation will be stratified by the presence or absence of a neurological disorder as the admitting diagnoses.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Between-group comparisons for each of the continuously-scored outcome measures will be made using linear models with baseline scores entered as a covariate. Primary analyses will use an intention-to-treat approach.

A total of 58 participants (29 per group) will provide 80% power to detect a significant, at the 5% level, 15% between-group difference in the continuous summary score of the SPPB. The sample size calculation assumed analysis using linear models with baseline scores entered as covariates and a correlation between pre- and post-measures of 0.7. For the continuous 3-point summary score of the SPPB the intervention group mean was assumed to 1.6, the standard deviation 0.41. We have allowed for a 20% dropout rate.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/05/2013
Actual
18/06/2013
Date of last participant enrolment
Anticipated
31/12/2013
Actual
29/10/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
58
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 878 0
Repatriation Hospital - Daw Park

Funding & Sponsors
Funding source category [1] 287079 0
Self funded/Unfunded
Name [1] 287079 0
Country [1] 287079 0
Primary sponsor type
University
Name
Flinders University
Address
in care of:
Daws Road, Daw Park
South Australia, 5041
Country
Australia
Secondary sponsor category [1] 286072 0
Hospital
Name [1] 286072 0
Repatriation General Hospital
Address [1] 286072 0
Daws Road, Daw Park
South Australia, 5041
Country [1] 286072 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289098 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 289098 0
Ethics committee country [1] 289098 0
Australia
Date submitted for ethics approval [1] 289098 0
Approval date [1] 289098 0
20/03/2012
Ethics approval number [1] 289098 0
036.13

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

Contacts
Principal investigator
Name 39222 0
Dr Maayken van den Berg
Address 39222 0
Flinders University
School of Medicine, Dep of Rehabilitation, Aged & Extended Care
Room 54, Level 1, C-Block
Repatriation General Hospital, Daws Road, Daw Park, South Australia, 5041
Country 39222 0
Australia
Phone 39222 0
+61 (08) 8275 1297
Fax 39222 0
Email 39222 0
[email protected]
Contact person for public queries
Name 39223 0
Maayken van den Berg
Address 39223 0
Flinders University
School of Medicine, Dep of Rehabilitation, Aged & Extended Care
Room 54, Level 1, C-Block
Repatriation General Hospital, Daws Road, Daw Park, South Australia, 5041
Country 39223 0
Australia
Phone 39223 0
+61 (08) 8275 1297
Fax 39223 0
Email 39223 0
[email protected]
Contact person for scientific queries
Name 39224 0
Maayken van den Berg
Address 39224 0
Flinders University
School of Medicine, Dep of Rehabilitation, Aged & Extended Care
Room 54, Level 1, C-Block
Repatriation General Hospital, Daws Road, Daw Park, South Australia, 5041
Country 39224 0
Australia
Phone 39224 0
+61 (08) 8275 1297
Fax 39224 0
Email 39224 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseVideo and computer-based interactive exercises are safe and improve task-specific balance in geriatric and neurological rehabilitation: a randomised trial.2016https://dx.doi.org/10.1016/j.jphys.2015.11.005
N.B. These documents automatically identified may not have been verified by the study sponsor.