Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000609651
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
6/10/2005
Date last updated
10/09/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of training somatosensation in the hand after stroke: A randomized controlled trial.
Scientific title
Effectiveness of training somatosensation in the hand after stroke: A randomized controlled trial.
Universal Trial Number (UTN)
Trial acronym
SENSe
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 740 0
Condition category
Condition code
Stroke 816 816 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The experimental intervention (EI) will comprise 10 sessions of generalized discrimination training of texture discrimination, limb position sense and tactual object recognition.
Sessions are 60-90 minutes duration and are conducted 3 times per week. Group A will receive two phases of EI. Group B will receive one phase of CI followed by one phase of EI.
Intervention code [1] 575 0
Rehabilitation
Comparator / control treatment
The control intervention (CI) will comprise 10 sessions of exposure to sensory stimuli.
Control group
Placebo

Outcomes
Primary outcome [1] 1048 0
A multi-scale score of sensory discrimination performance based on improvement in the discrimination of functionally relevant sensory stimuli, i.e. texture discrimination, limb position sense and tactual object recognition.
Timepoint [1] 1048 0
Outcome assessments will be conducted at baseline, just prior to the commencement of the initial phase, and at the end of phase two. Follow-up assessments will be conducted at 6 weeks and 6 months post training to determine maintenance of training effects. Between-group comparison of intervention effect will be conducted at the end of phase one. Within-group comparison of intervention effect will compare change during EI with preceding change during CI.
Primary outcome [2] 1049 0
Hand function in self-care activities (measured using the Sequential Occupational Dexterity Assessment).
Timepoint [2] 1049 0
Outcome assessments will be conducted at baseline, just prior to the commencement of the initial phase, and at the end of phase two. Follow-up assessments will be conducted at 6 weeks and 6 months post training to determine maintenance of training effects. Between-group comparison of intervention effect will be conducted at the end of phase one. Within-group comparison of intervention effect will compare change during EI with preceding change during CI.
Secondary outcome [1] 1951 0
Actual use of the upper limb in life situations will be measured using the Upper Extremity Motor Activity Log (UE/MAL).
Timepoint [1] 1951 0
These measures will be administered at the same time points as for the primary outcome measures.
Secondary outcome [2] 1952 0
The Barthel Index (BI) will also be employed as a secondary measure to provide a more global disability measure of performance in daily self-care activities.
Timepoint [2] 1952 0
These measures will be administered at the same time points as for the primary outcome measures.

Eligibility
Key inclusion criteria
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

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)
Centralised randomisation with the person assigning the subjects different to the executor of the assignment. Allocation is communicated via sealed, opaque envelopes and/or confidential email.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation using computer random number generator with matching constraints.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Group A: E1, E1 and Group B: C1, E1
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/01/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 905 0
Government body
Name [1] 905 0
NHMRC
Country [1] 905 0
Australia
Primary sponsor type
University
Name
LaTrobe University
Address
Country
Australia
Secondary sponsor category [1] 764 0
Other
Name [1] 764 0
National Stroke Research Institute
Address [1] 764 0
Country [1] 764 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2188 0
Austin Health
Ethics committee address [1] 2188 0
Ethics committee country [1] 2188 0
Australia
Date submitted for ethics approval [1] 2188 0
Approval date [1] 2188 0
Ethics approval number [1] 2188 0
Ethics committee name [2] 2189 0
LaTrobe University
Ethics committee address [2] 2189 0
Ethics committee country [2] 2189 0
Australia
Date submitted for ethics approval [2] 2189 0
Approval date [2] 2189 0
Ethics approval number [2] 2189 0
Ethics committee name [3] 2190 0
Melbourne Health
Ethics committee address [3] 2190 0
Ethics committee country [3] 2190 0
Australia
Date submitted for ethics approval [3] 2190 0
Approval date [3] 2190 0
Ethics approval number [3] 2190 0
Ethics committee name [4] 2191 0
Southern Health
Ethics committee address [4] 2191 0
Ethics committee country [4] 2191 0
Australia
Date submitted for ethics approval [4] 2191 0
Approval date [4] 2191 0
Ethics approval number [4] 2191 0
Ethics committee name [5] 2192 0
Northern Health
Ethics committee address [5] 2192 0
Ethics committee country [5] 2192 0
Australia
Date submitted for ethics approval [5] 2192 0
Approval date [5] 2192 0
Ethics approval number [5] 2192 0
Ethics committee name [6] 2193 0
Barwon Health
Ethics committee address [6] 2193 0
Ethics committee country [6] 2193 0
Australia
Date submitted for ethics approval [6] 2193 0
Approval date [6] 2193 0
Ethics approval number [6] 2193 0
Ethics committee name [7] 2194 0
Donvale Rehabilitation Hospital
Ethics committee address [7] 2194 0
Ethics committee country [7] 2194 0
Australia
Date submitted for ethics approval [7] 2194 0
Approval date [7] 2194 0
Ethics approval number [7] 2194 0

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

Contacts
Principal investigator
Name 36399 0
Address 36399 0
Country 36399 0
Phone 36399 0
Fax 36399 0
Email 36399 0
Contact person for public queries
Name 9764 0
Professor Leeanne Carey
Address 9764 0
National Stroke Research Institute
Austin Health
Repatriation Campus
Neurosciences Building
300 Waterdale Road
Heidelberg Heights VIC 3081
Country 9764 0
Australia
Phone 9764 0
+61 3 94962586
Fax 9764 0
+61 3 94962650
Email 9764 0
[email protected]
Contact person for scientific queries
Name 692 0
Professor Leeanne Carey
Address 692 0
National Stroke Research Institute
Austin Health
Repatriation Campus
Neurosciences Building
300 Waterdale Road
Heidelberg Heights VIC 3081
Country 692 0
Australia
Phone 692 0
+61 3 94962586
Fax 692 0
+61 3 94962650
Email 692 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
Dimensions AIAltered functional connectivity differs in stroke survivors with impaired touch sensation following left and right hemisphere lesions2018https://doi.org/10.1016/j.nicl.2018.02.012
N.B. These documents automatically identified may not have been verified by the study sponsor.