Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001075976
Ethics application status
Approved
Date submitted
10/03/2008
Date registered
18/10/2011
Date last updated
18/10/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Training of reaching using the SMART Arm (Sensorimotor active rehabilitation training of the arm) to promote upper limb recovery after stroke: Phase II pilot study
Scientific title
A pilot study to compare use of the SMART Arm (novel, non-robotic device) with and without outcome triggered electrical stimulation to improve upper limb function in stroke survivors with severe and acute upper limb paresis
Secondary ID [1] 273213 0
Nil
Universal Trial Number (UTN)
U1111-1125-2461
Trial acronym
SMART Arm
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 2921 0
upper limb paresis 2922 0
recovery 278976 0
Condition category
Condition code
Neurological 3054 3054 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 279153 279153 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will undertake 20 training sessions (5 per week) to achieve 60-80 repetitions of reaching per session over a four week period using the SMART Arm with outcome triggered electrical stimulation. Training sessions will be conducted individually and administered by the treating physiotherapist or occupational therapist who has received training in use of the SMART Arm.

The SMART Arm (Sensory Motor Active Rehabilitation Training of the Arm) is a novel, non-robotic training device that is specifically designed so that stroke survivors with little muscle activity can practice a reaching task along a straight line path, consistent with a normal reaching pattern. The SMART Arm can be used with or without outcome triggered electrical stimulation. Outcome triggered electrical stimulation means that when the stroke survivor reaches a preset reaching distance the SMART Arm will trigger delivery of electrical stimulation to the triceps muscle to assis the stroke survivor to complete the reaching task through full range.
Intervention code [1] 2649 0
Rehabilitation
Comparator / control treatment
Participants in the control group will also undertake 20 training sessions to achieve 60-80 repetitions of reaching per session over a four week period. However they will use the SMART Arm WITHOUT electrical stimulation
Control group
Active

Outcomes
Primary outcome [1] 3939 0
Upper arm function as measured by the Item 6 on the Motor Assessment Scale
Timepoint [1] 3939 0
Pre and post intervention
Secondary outcome [1] 6621 0
Triceps muscle power using Manual Muscle Testing
Timepoint [1] 6621 0
Pre and post intervention
Secondary outcome [2] 294438 0
Resistance to passive elbow extension using the Modified Ashworth Scale
Timepoint [2] 294438 0
Pre and post intervention
Secondary outcome [3] 294439 0
Pain - Visual analogue scale and Ritchie Arcticular Index
Timepoint [3] 294439 0
Pre and post intervention
Secondary outcome [4] 294440 0
Hand function using the Upper limb items 7 and 8 of the Motor Assessment Scale MAS (6-8)
Timepoint [4] 294440 0
Pre and post intervention
Secondary outcome [5] 294441 0
Stroke Impact Scale
Timepoint [5] 294441 0
Pre and post intervention

Eligibility
Key inclusion criteria
First ever stroke less than 3 months previously
Less than grade 3 triceps muscle strength
An inability to perform a standardised reaching task and
Able to understand instructions and provide informed consent
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Upper extremity comorbidities with the potential to limit function
An inability to tolerate electrical stimulation or
Medically unstable

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)
Based on a recruitment screening sheet, potential participants will be identified by occupational therapy staff at The Townsville Hospital. A designated senior occupational therapist will then provide the potential participants with an explanation of the study and participant information sheet and invite them to participate. Once the participant has agreed to participate and signed the consent form, the initial assessment will be conducted by a blinded assessor. Following the initial assessment, the participant will be randomised to one of the two intervention groups using a computer generated random number concealed in sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple computer generated randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/03/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 602 0
4814

Funding & Sponsors
Funding source category [1] 3171 0
Self funded/Unfunded
Name [1] 3171 0
Country [1] 3171 0
Primary sponsor type
University
Name
James Cook University
Address
Discipline of Physiotherapy
Rehabilitation and Exercise Sciences
Douglas Campus
James Cook University
Queensland 4811
Country
Australia
Secondary sponsor category [1] 2843 0
Hospital
Name [1] 2843 0
The Townsville Hospital
Address [1] 2843 0
100 Angus Smith Drive Douglas
Queensland 4814
Country [1] 2843 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5152 0
Townsville Health Service District Human Research Ethics Committee
Ethics committee address [1] 5152 0
100 Angus Smith Drive Douglas
Queensland 4814
Ethics committee country [1] 5152 0
Australia
Date submitted for ethics approval [1] 5152 0
Approval date [1] 5152 0
Ethics approval number [1] 5152 0
48/07

Summary
Brief summary
This project is a pilot trial of a novel, non-robotic training device, the SMART Arm, to retrain upper limb function in stroke survivors with severe paresis. The aim of the trial is to determine the extent to which training of reaching using the SMART Arm with outcome triggered electrical stimulation, will lead to improvements in upper limb function for stroke survivors with severe upper limb paresis who are in the acute stage of recovery. In a pilot randomised control trial, 12 inpatients undertaking rehabilitation at The Townsville Hospital and who have had a first ever stroke within the previous three months will be recruited to the study. The participants will be randomly allocated to Intervention A or Intervention B groups. Participants allocated to the Intervention A will receive SMART Arm training WITH electrical stimulation and 30 minutes of usual care for 30 minutes per day, five days a week for four weeks. Participants allocated to Intervention B will receive 30 minutes of SMART Arm training WITHOUT electrical stimulation and 30 minutes of usual care, five days a week for four weeks. All training will be provided by Occupational Therapy staff of The Townsville Hospital rehabilitation unit. Pre-intervention and post-intervention assessment of arm impairment and activity will be undertaken by a blinded assessor. Study outcomes will be used to refine the training device and protocol and to estimate the required sample size for a follow-up RCT.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28432 0
Address 28432 0
Country 28432 0
Phone 28432 0
Fax 28432 0
Email 28432 0
Contact person for public queries
Name 11589 0
Ruth Barker
Address 11589 0
Discipline of Physiotherapy
Rehabilitation and Exercise Sciences
Douglas Campus
James Cook University
Queensland 4811
Country 11589 0
Australia
Phone 11589 0
61 7 47816003
Fax 11589 0
61 7 47816868
Email 11589 0
ruth.barker@jcu.edu.au
Contact person for scientific queries
Name 2517 0
Ruth Barker
Address 2517 0
Discipline of Physiotherapy
Rehabilitation and Exercise Sciences
Douglas Campus
James Cook University
Queensland 4811
Country 2517 0
Australia
Phone 2517 0
61 7 47816003
Fax 2517 0
61 7 47816868
Email 2517 0
ruth.barker@jcu.edu.au

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
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Documents added automatically
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