Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001009000
Ethics application status
Approved
Date submitted
29/01/2010
Date registered
18/11/2010
Date last updated
28/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Bilateral Upper Limb Trial: An evaluation of the Bilateral Upper Limb Trainer (BUiLT) plus Virtual Reality for post-stroke upper limb rehabilitation.
Scientific title
Randomised controlled trial of the Bilateral Upper Limb Trainer (BUiLT) + Virtual Reality for post-stroke upper limb rehabilitation.
Secondary ID [1] 1369 0
nil
Universal Trial Number (UTN)
Trial acronym
BUiLT Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke Rehabilitation 256708 0
Condition category
Condition code
Stroke 256864 256864 0 0
Ischaemic
Stroke 256865 256865 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 256896 256896 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Volunteers diagnosed with sub-acute or chronic stroke and having upper limb hemiparesis will train using a novel non-robotic and bilateral upper limb training device (BUiLT) coupled with computer games that provide therapeutic exercise. Each participant will train for 6 weeks and undergo 4x45 min sessions per week and the BUiLT training will be in addition to standard therapy. Training will be administered/supervised by specifically trained BUiLT operators and/or physiotherapists.
Intervention code [1] 255938 0
Rehabilitation
Intervention code [2] 255939 0
Treatment: Devices
Comparator / control treatment
Standard therapy: As directed by hospital or community-based physiotherapists and occupational therapists. Total time spent in therapy and upper limb specific therapy time will be recorded for 6 weeks. Specific techniques will not be recorded.
After the 6 month assessment the original control group will be offered BUiLT + VR therapy using the same regime in order to ascertain the effects of the therapy in this (now chronic) group. They will be assessed at the completion of that therapy.
Control group
Active

Outcomes
Primary outcome [1] 257731 0
Fugl-Meyer Upper Limb Motor Score
Timepoint [1] 257731 0
Baseline, post-intervention/wk 7 and 6 mths post-intervention/wk 31
Primary outcome [2] 257732 0
Shoulder and elbow isometric strength (dynamometry)
Timepoint [2] 257732 0
Baseline, post-intervention/wk 7 and 6 mths post-intervention/wk 31
Primary outcome [3] 257733 0
Intrinsic Motivation Inventory
Timepoint [3] 257733 0
Post 6 wks intervention/wk 7
Secondary outcome [1] 263097 0
Change in Fugl-Meyer Upper Limb Motor Score
Timepoint [1] 263097 0
Post-(2nd) intervention/wk 38
Secondary outcome [2] 263098 0
Shoulder and elbow isometric strength (dynamometry)
Timepoint [2] 263098 0
Post-(2nd) intervention/wk 38
Secondary outcome [3] 263099 0
Intrinsic Motivation Inventory
Timepoint [3] 263099 0
Post intervention/wk 38

Eligibility
Key inclusion criteria
(1) Obtained and signed informed consent. (2) Completed Physician/Doctor medical clearance. (3) Diagnosis of first time ischaemic or haemorrhagic cerebrovascular accident, discharged from acute care and not >36 months post stroke with resulting contralateral upper limb weakness. (4) Living within the Christchurch City Council urban zone or having sufficient means to reliably travel to the clinical trial centre
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Inability to provide informed consent. (2) Pre-existing neurological conditions or previous brain trauma. (3) History of extra-axial cranial haemorrhage or a history of epidural or sub-dural haemorrhage. (4) Range of movement limitation due to pain, previous trauma or pre-existing conditions. (5) Diagnosed psychological disorder at time of screening that is likely to prevent full participation. (6) Cognitive impairment. (7) Neglect of the affected side. (8) Inability to correctly visualize the trial computer game. (9) Receiving upper limb rehabilitation from another provider in addition to the standard care. (10) Unstable medical or cardiovascular status, malignancy, musculoskeletal condition, immune deficiency, systemic illness, infection, pain, lack of upper limb skin integrity or any other condition that limits upper limb movement and the ability to complete the proposed intervention (other than that permitted). (11) Upper limb lymphodema. (12) Grade 4 or greater for shoulder flexion and elbow flexion power:

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)
Central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation by computer software (random sequence generator)
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
Suspended
Date of first participant enrolment
Anticipated
1/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
56
Accrual to date
Final
Recruitment outside Australia
Country [1] 2450 0
New Zealand
State/province [1] 2450 0
Canterbury

Funding & Sponsors
Funding source category [1] 256431 0
Government body
Name [1] 256431 0
Foundation for Research, Science and Technology (FRST)
Country [1] 256431 0
New Zealand
Primary sponsor type
Other
Name
Industrial Research Ltd (IRL)
Address
PO Box 20-028
Christchurch 8543
Country
New Zealand
Secondary sponsor category [1] 255735 0
Charities/Societies/Foundations
Name [1] 255735 0
Burwood Academy of Independent Living
Address [1] 255735 0
Private Bag 4708
Christchurch 8140
Country [1] 255735 0
New Zealand
Other collaborator category [1] 1092 0
Hospital
Name [1] 1092 0
Canterbury District Health Board
Address [1] 1092 0
CDHB Older Persons Health Specialist Service
PO Box 800
Christchurch 8140
Country [1] 1092 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258487 0
Upper A Regional Ethics Committee
Ethics committee address [1] 258487 0
Ministry of Health
PO Box 3877
Christchurch 8140
Ethics committee country [1] 258487 0
New Zealand
Date submitted for ethics approval [1] 258487 0
Approval date [1] 258487 0
24/11/2009
Ethics approval number [1] 258487 0
URA/09/10/070

Summary
Brief summary
The research study will trial the Bilateral Upper Limb Trainer incorporating virtual reality (BUiLT + VR) system to establish its effectiveness as therapeutic table-top rehabilitation for the weakened upper limb of subjects who have suffered a stroke. VR is where a computer displays task-based ‘games’ that direct and prompt the user to exercise whilst providing feedback on performance. This will be done by comparing the outcomes of 6 weeks of 4 sessions per week BUiLT + VR therapy in a randomly selected group of sub acute and chronic stroke participants against a matched group of participants who will receive only their usual conventional therapy regime over that time. Assessment using established physical outcome measures and a questionnaire will occur before and after the 6 weeks of therapy and then again 6 months later. After the 6 month assessment the original control group will be offered BUiLT + VR therapy using the same regime in order to ascertain the effects of the therapy in this (now chronic) group. They will be assessed at the completion of that therapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30785 0
Address 30785 0
Country 30785 0
Phone 30785 0
Fax 30785 0
Email 30785 0
Contact person for public queries
Name 14032 0
Marcus King
Address 14032 0
Industrial Research Ltd
PO Box 20-028
Christchurch 8543
Country 14032 0
New Zealand
Phone 14032 0
+64 3 3586810
Fax 14032 0
+64 3 3589506
Email 14032 0
[email protected]
Contact person for scientific queries
Name 4960 0
Michael Sampson
Address 4960 0
Burwood Academy of Independent Living
Private Bag 4708
Christchurch 8140
Country 4960 0
New Zealand
Phone 4960 0
+64 3 3586806
Fax 4960 0
+64 3 3589506
Email 4960 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

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