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Trial registered on ANZCTR


Registration number
ACTRN12609000777291
Ethics application status
Approved
Date submitted
7/09/2009
Date registered
7/09/2009
Date last updated
7/09/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of robotic-assisted upper limb therapy on upper limb improvements following stroke
Scientific title
The effect of robot assisted upper limb therapy compared to usual care on upper limb improvements following stroke
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 243673 0
Condition category
Condition code
Stroke 239942 239942 0 0
Ischaemic
Stroke 239943 239943 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
15 minutes of upper limb robotic therapy using the Bimanutrack as part of 45 minute treatment session with remainder standard treatment. Robotic therapy consists of 150-250 repetitions of passive and/or active-passive program on Bimanutrack robotic in both wrist flexion-extension, and pronation-supination positions. Intervention is provided 5 days per week for 4 weeks within usual 45 minute therapy session.
Intervention code [1] 241222 0
Rehabilitation
Comparator / control treatment
Standard treatment 5 days per week for 4 weeks with 45 minute session duration per day. Standard Treatment - includes bilateral training, relaxation, visualisation, grasp/release activities, passive range of motion with therapist, resisted strength training (eg with weighted cuffs), massage, and use of upper limb in functional tasks.
Control group
Active

Outcomes
Primary outcome [1] 240749 0
Wolf Motor Function Test
Timepoint [1] 240749 0
At baseline, and immediately and 3 months after intervention ceases.
Secondary outcome [1] 257403 0
Fugl Meyer Assessment of Motor Function
Timepoint [1] 257403 0
At baseline, and immediately and 3 months after intervention ceases.
Secondary outcome [2] 257404 0
Active range of motion of wrist flexion and extension, and forearm supination and pronation - measured using a goniometer.
Timepoint [2] 257404 0
At baseline, and immediately and 3 months after intervention ceases.

Eligibility
Key inclusion criteria
Diagnosis of stroke
No premorbid neurological deficits
Sufficient receptive and expressive language and cognitive ability to understand the study and provide consent
Sufficient sitting balance to use the robotic
Motor power grade of 3 or less in wrist flexion/extension and /or elbow pronation/supination.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Upper limb contractures
Significant increased tone (Modified Ashworth Scale =4)
Active arthritis in finger, elbow or wrist joints
Shoulder-hand syndrome

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/09/2009
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] 243605 0
Charities/Societies/Foundations
Name [1] 243605 0
Foundation Daw Park
Country [1] 243605 0
Australia
Primary sponsor type
Individual
Name
Sharyn Chaplin
Address
Daws Rd, Daw Park, South Australia 5041
Country
Australia
Secondary sponsor category [1] 237054 0
Individual
Name [1] 237054 0
Karen Brown
Address [1] 237054 0
Daws Rd, Daw Park, South Australia 5041
Country [1] 237054 0
Australia
Other collaborator category [1] 839 0
Individual
Name [1] 839 0
Stacey George
Address [1] 839 0
Daws Rd, Daw Park, South Australia 5041
Country [1] 839 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243730 0
Repatriation General Hospital (RGH) Research and Ethics Committee
Ethics committee address [1] 243730 0
Ethics committee country [1] 243730 0
Australia
Date submitted for ethics approval [1] 243730 0
Approval date [1] 243730 0
15/09/2008
Ethics approval number [1] 243730 0
31.08

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

Contacts
Principal investigator
Name 30151 0
Address 30151 0
Country 30151 0
Phone 30151 0
Fax 30151 0
Email 30151 0
Contact person for public queries
Name 13398 0
Sharyn Chaplin
Address 13398 0
Repatriation General Hospital
Daws Rd, Daw Park, South Australia 5041
Country 13398 0
Australia
Phone 13398 0
+61 8 8275 1710
Fax 13398 0
Email 13398 0
Sharyn.Chaplin@health.sa.gov.au
Contact person for scientific queries
Name 4326 0
Sharyn Chaplin
Address 4326 0
Repatriation General Hospital
Daws Rd, Daw Park, South Australia 5041
Country 4326 0
Australia
Phone 4326 0
+ 61 8 8275 1710
Fax 4326 0
Email 4326 0
Sharyn.Chaplin@health.sa.gov.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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.