Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615001222538
Ethics application status
Approved
Date submitted
28/10/2015
Date registered
9/11/2015
Date last updated
10/01/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Combined Physical and SEnsOry (ComPoSE) training to improve arm function after stroke
Scientific title
Combined Physical and SEnsOry (ComPoSE) training to improve arm function after stroke
Secondary ID [1] 287741 0
nil
Universal Trial Number (UTN)
Trial acronym
ComPoSE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 296604 0
Sensory deficits 296606 0
Movement deficits 296607 0
Condition category
Condition code
Stroke 296921 296921 0 0
Ischaemic
Stroke 296935 296935 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 296955 296955 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
COMPOSE intervention consists of sensorimotor training tasks with graded progression of difficulty (progressing from easy to more difficult discriminations) within each specific parameter in order to challenge the system and encourage neural plastic changes in interconnected networks. Parameters include motor parameters (distance, speed, and object size) and sensory parameters (surface hardness, surface texture and surface friction). The intervention phase consists of 10 treatment sessions of COMPoSE intervention (each 1.5 hour) over a period of 3 weeks. 4 treatment sessions will be delivered in week 1 and 3 treatment sessions in week 2 and 3. Treatment will be provided by a physiotherapist at the Hunter Medical Research Institute, NSW Australia.
Intervention code [1] 293141 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296457 0
3 D kinematic measures (movement duration) using Qualysis motion capture
Timepoint [1] 296457 0
Pre intervention (baseline), post intervention (3 weeks), and 1 month post completion of intervention
Primary outcome [2] 296458 0
Graded tactile pressure using Tactarray pressure distribution system
Timepoint [2] 296458 0
Pre intervention (baseline), post intervention (3 weeks), and 1 month post completion of intervention
Primary outcome [3] 296547 0
3 D kinematic measures (peak hand velocity) using Qualysis motion capture
Timepoint [3] 296547 0
Pre intervention (baseline), post intervention (3 weeks), and 1 month post completion of intervention
Secondary outcome [1] 318681 0
WOLF motor function test
Timepoint [1] 318681 0
Pre intervention (baseline), post intervention (3 weeks), and 1 month post completion of intervention
Secondary outcome [2] 318682 0
Motor activity log
Timepoint [2] 318682 0
Pre-intervention (baseline), post intervention (3 weeks), and 1 month post completion of intervention
Secondary outcome [3] 318683 0
Tactile discrimination test
Timepoint [3] 318683 0
Pre-intervention (baseline), post intervention (3 weeks), and 1 month post completion of intervention
Secondary outcome [4] 318684 0
Fabric Matching Test
Timepoint [4] 318684 0
Pre intervention (baseline), post intervention (3 weeks), and 1 month post completion of intervention
Secondary outcome [5] 318685 0
Wrist Position Sense Test
Timepoint [5] 318685 0
Pre intervention (baseline), post intervention (3 weeks), and 1 month post completion of intervention
Secondary outcome [6] 318687 0
Functional Tactile Object Recognition Test
Timepoint [6] 318687 0
Pre intervention (baseline), post intervention (3 weeks), and 1 month post completion of intervention
Secondary outcome [7] 318688 0
Stroke Impact Scale
Timepoint [7] 318688 0
Pre intervention (baseline), post intervention (3 weeks), and 1 month post completion of intervention
Secondary outcome [8] 318689 0
Fatigue Assessment Scale
Timepoint [8] 318689 0
Pre intervention (baseline), post intervention (3 weeks), and 1 month post completion of intervention
Secondary outcome [9] 318690 0
Stanford Fatigue Visual Analogue Scale
Timepoint [9] 318690 0
Pre intervention (baseline), post intervention (3 weeks), and 1 month post completion of intervention
Secondary outcome [10] 318691 0
Pain visual analogue scale
Timepoint [10] 318691 0
Pre intervention (baseline), post intervention (3 weeks), and 1 month post completion of intervention
Secondary outcome [11] 318692 0
Grip Force using the Jamar dynamometer
Timepoint [11] 318692 0
Pre intervention (baseline), post intervention (3 weeks), and 1 month post completion of intervention
Secondary outcome [12] 318721 0
Primary outcome measure: 3 D kinematic measures (time of peak hand velocity) using Qualysis motion capture
Timepoint [12] 318721 0
Pre intervention (baseline), post intervention (3 weeks), and 1 month post completion of intervention
Secondary outcome [13] 318723 0
Primary outcome measure: 3 D kinematic measures (peak hand velocity) using Qualysis motion capture
Timepoint [13] 318723 0
Pre intervention (baseline), post intervention (3 weeks), and 1 month post completion of intervention
Secondary outcome [14] 318724 0
Primary outcome measure: 3 D kinematic measures(peak deceleration) using Qualysis motion capture
Timepoint [14] 318724 0
Pre intervention (baseline), post intervention (3 weeks), and 1 month post completion of intervention
Secondary outcome [15] 318725 0
Primary outcome measure: 3 D kinematic measures(time of peak deceleration) using Qualysis motion capture
Timepoint [15] 318725 0
Pre intervention (baseline), post intervention (3 weeks), and 1 month post completion of intervention
Secondary outcome [16] 318726 0
Primary outcome measure: 3 D kinematic measures(peak grasp aperture) using Qualysis motion capture
Timepoint [16] 318726 0
Pre intervention (baseline), post intervention (3 weeks), and 1 month post completion of intervention
Secondary outcome [17] 318727 0
Primary outcome measure: 3 D kinematic measures(time of grasp aperture) using Qualysis motion capture
Timepoint [17] 318727 0
Pre intervention (baseline), post intervention (3 weeks), and 1 month post completion of intervention

Eligibility
Key inclusion criteria
The participants will be included if: they are adults aged 18+ years, having a confirmed diagnosis of stroke (haemorrhagic or ischaemic); 2) they have sufficient voluntary muscle contraction in the paretic upper limb to reach forward and generate the beginning of prehension; and they have either or both of 3) they have remaining upper limb movement deficit defined as being unable to pick up a 6mm ball bearing from the table top between index finger and thumb, and place it on a shelf 37 cm above table (item from Action research Arm test) or 4) they have somatosensory impairment in the upper limb identified by any of the following: the texture discrimination tests (Tactile Discrimination Test and Fabric Matching Test), limb position sense (Wrist Position Sense or Test) and tactile object recognition (functional Tactile Object Recognition Test); 5) they have no obvious motor dyspraxia as assessed by ability to imitate a reaching movement with the non-paretic upper limb; 7) they are able, prior to the stroke, to use the paretic upper limb to lift a cup and drink from it; 8) able to follow a 1-stage command i.e. sufficient cognitive ability for interventions in this trial.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they have: 1) a prior history of central nervous system dysfunction other than stroke; 2) upper limb deficits resulting from non-stroke pathology;3) any peripheral neuropathy and 4) moderate to severe receptive aphasia (<10 on ‘receptive skills’ of Sheffield Screening Test for Acquired Language Disorders).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Multiple baseline repeated measures and repeated measures throughout intervention phase
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analyses:
Repeated measures Multivariate Analysis of Variance (MANOVA) on raw scores and change score methods adjusting for baseline measures will be performed along with Bonferroni-Holm correction post-hoc analyses.

Sample size calculation:
A sample size of 16 participants will give 90% power to detect a difference of 8% for time of peak velocity (%)(9SDs), 1.02 sec for time of peak grasp aperture(sec) (0.85 SDs). 11.1 change score on the standardised somatosensory deficits (11SDs, 5% significance level).
The sample size needed for the trial was calculated a priori to ensure sufficient statistical power. The variance and effect size needed for kinematic parameters to calculate the number of patients was estimated from the results of a previous study on arm recovery after stroke (van Vliet and Sheridan, 2007). Standardised somatosensory deficits score will be calculated from the pooled results of the standardised Fabric Matching Test, Wrist Position Sense Test, Functional Tactile Object Recognition Test scores. The values for mean change and standard deviation of the standardised somatosensory deficits score will be adjusted based on results from a recent study (Carey, Macdonell, 2011).



Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
20/10/2015
Date of last participant enrolment
Anticipated
31/10/2017
Actual
30/11/2016
Date of last data collection
Anticipated
31/07/2018
Actual
Sample size
Target
16
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 4513 0
Belmont Hospital - Belmont
Recruitment hospital [2] 4514 0
Cessnock District Hospital - Cessnock
Recruitment hospital [3] 4515 0
Maitland Private Hospital - East Maitland
Recruitment hospital [4] 4516 0
Maitland Hospital - Maitland
Recruitment hospital [5] 4517 0
Hunter Medical Research Institute - New Lambton Heights

Funding & Sponsors
Funding source category [1] 292287 0
University
Name [1] 292287 0
University of Newcastle
Country [1] 292287 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
School of Health Sciences
Faculty of Health and Medicine
University of Newcastle,
University Drive
Callaghan, NSW, 2308
Country
Australia
Secondary sponsor category [1] 290972 0
None
Name [1] 290972 0
Address [1] 290972 0
Country [1] 290972 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293760 0
Hunter New England Human Research Health Committee
Ethics committee address [1] 293760 0
Ethics committee country [1] 293760 0
Australia
Date submitted for ethics approval [1] 293760 0
28/11/2013
Approval date [1] 293760 0
10/02/2014
Ethics approval number [1] 293760 0
HNEHREC Reference No: 13/12/11/4.02
Ethics committee name [2] 293761 0
Human Research Ethics Committee (HREC), University of Newcastle, Australia
Ethics committee address [2] 293761 0
Ethics committee country [2] 293761 0
Australia
Date submitted for ethics approval [2] 293761 0
30/01/2015
Approval date [2] 293761 0
05/03/2015
Ethics approval number [2] 293761 0
HREC Reference No: H-2015-0052

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

Contacts
Principal investigator
Name 61202 0
Prof Prof Robin Callister
Address 61202 0
School of Biomedical Sciences and Pharmacy, Faculty of Health and Medicine, University of Newcastle, ATC Building Level 3,Callaghan University Drive, Callaghan, NSW 2308
Australia
Country 61202 0
Australia
Phone 61202 0
+61 2 4921 5650
Fax 61202 0
Email 61202 0
[email protected]
Contact person for public queries
Name 61203 0
Urvashy Gopaul
Address 61203 0
School of Health Sciences
Faculty of Health and Medicine
University of Newcastle

Hunter Medical Research Institute
Kookaburra Circuit
New Lambton Heights
NSW, 2305
Country 61203 0
Australia
Phone 61203 0
+61 240421602
Fax 61203 0
Email 61203 0
[email protected]
Contact person for scientific queries
Name 61204 0
Urvashy Gopaul
Address 61204 0
School of Health Sciences
Faculty of Health and Medicine
University of Newcastle

Hunter Medical Research Institute
Kookaburra Circuit
New Lambton Heights
NSW, 2305
Country 61204 0
Australia
Phone 61204 0
+61 240421602
Fax 61204 0
Email 61204 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
No additional documents have been identified.