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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01246882




Registration number
NCT01246882
Ethics application status
Date submitted
22/11/2010
Date registered
23/11/2010
Date last updated
1/05/2019

Titles & IDs
Public title
Stroke Inpatient Rehabilitation Reinforcement of ACTivity
Scientific title
Stroke Inpatient Rehabilitation Reinforcement of ACTivty: An International Multisite Clinical Trial
Secondary ID [1] 0 0
10-000134
Universal Trial Number (UTN)
Trial acronym
SIRRACT
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Augmented activity feedback
Behaviour - Speed-only feedback

Experimental: Augmented activity feedback - Feedback three times per week about 10-m walking speed, plus amount and types of physical activity measured using wireless bilateral ankle sensors that detect bouts of walking and cycling speed, duration, and distance.

Active Comparator: speed-only feedback - Feedback three times per week about overground walking speed over 10 meters.


Behaviour: Augmented activity feedback
Feedback about walking speed and amount of physical activity will be provided 3 times per week from data acquired from wireless sensors on each ankle.

Behaviour: Speed-only feedback
Feedback about walking speed will be provided 3 times per week.
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Gait speed
Timepoint [1] 0 0
Discharge
Secondary outcome [1] 0 0
Distance walked in 3 minutes
Timepoint [1] 0 0
Discharge

Eligibility
Key inclusion criteria
- Admission for acute inpatient rehabilitation of a first stroke (or second stroke after
full recovery from prior TIA/Stroke)

- Time from onset of stroke to admission for rehabilitation < 35 days

- Stroke from any cause (thrombotic infarct, cardioembolus, intracerebral hemorrhage)
that includes unilateral hemiparesis. Hemiparesis means less than / equal to 4/5
strength by the British Medical Council scale for hip flexion tested supine and for
knee or ankle flexion and extension (scores less than / equal to 22 of 25 possible
points)

- Ability to follow simple instructions, especially to understand verbal reinforcement
about activity.

- Independent in mobility prior to admission by the Barthel Index.

- Able to walk with no more than physical assistance of 2 persons for at least 5 steps
(for example, 3 strides of the left leg alternating with 2 on the right leg). Subjects
can use any type of assistive device and brace needed.

- Able to understand and repeat information related to the Informed Consent. The subject
signs a Consent form.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Current medical disease that will limit physical therapy at the time of randomization
or limited walking prior to the stroke, such as serious infection, DVT, orthostatic
hypotension, > stage 2 decubitus ulcer of buttocks or legs, congestive heart failure,
claudication, and pain with weight-bearing or walking. Subjects can be entered if a
complication resolves within 7 days of admission screening.

- Aphasia with inability to follow 2-step directions during therapeutic instructions or
answers Yes/No to questions with < 75% accuracy related to personal health and
symptoms.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2012
Sample size
Target
Accrual to date
Final
140
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
United States of America
State/province [2] 0 0
Minnesota
Country [3] 0 0
United States of America
State/province [3] 0 0
Missouri
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
Egypt
State/province [6] 0 0
Cairo
Country [7] 0 0
India
State/province [7] 0 0
Karnataka
Country [8] 0 0
Ireland
State/province [8] 0 0
Dublin
Country [9] 0 0
Italy
State/province [9] 0 0
Milan
Country [10] 0 0
Italy
State/province [10] 0 0
Venice
Country [11] 0 0
Japan
State/province [11] 0 0
Osaka
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Gwangju
Country [13] 0 0
New Zealand
State/province [13] 0 0
Christchurch
Country [14] 0 0
Nigeria
State/province [14] 0 0
Ibadan
Country [15] 0 0
Spain
State/province [15] 0 0
Barcelona
Country [16] 0 0
Spain
State/province [16] 0 0
Vigo
Country [17] 0 0
Taiwan
State/province [17] 0 0
Taipei
Country [18] 0 0
Turkey
State/province [18] 0 0
Ankara

Funding & Sponsors
Primary sponsor type
Other
Name
University of California, Los Angeles
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Taiwan University Hospital
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Washington University School of Medicine
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
University of Vigo
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Morinomiya Hospital, Osaka, Japan
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Mayo Clinic
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
IRCCS San Camillo, Venezia, Italy
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Fairlawn Hospital, Worcester, MA, USA
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Chonnam National University Hospital
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
Ain Shams University
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Other
Name [10] 0 0
MedStar National Rehabilitation Network
Address [10] 0 0
Country [10] 0 0
Other collaborator category [11] 0 0
Other
Name [11] 0 0
St. Luke's Hospital, Pennsylvania
Address [11] 0 0
Country [11] 0 0
Other collaborator category [12] 0 0
Other
Name [12] 0 0
Father Muller Medical College
Address [12] 0 0
Country [12] 0 0
Other collaborator category [13] 0 0
Other
Name [13] 0 0
Burke Rehabilitation Hospital
Address [13] 0 0
Country [13] 0 0
Other collaborator category [14] 0 0
Other
Name [14] 0 0
Burwood Hospital, Christchurch, New Zealand
Address [14] 0 0
Country [14] 0 0
Other collaborator category [15] 0 0
Other
Name [15] 0 0
Gazi University
Address [15] 0 0
Country [15] 0 0
Other collaborator category [16] 0 0
Other
Name [16] 0 0
University College Hospital, Ibadan, Nigeria
Address [16] 0 0
Country [16] 0 0
Other collaborator category [17] 0 0
Other
Name [17] 0 0
Rehabilitation Hospital, Barcelona, Spain
Address [17] 0 0
Country [17] 0 0
Other collaborator category [18] 0 0
Other
Name [18] 0 0
IRCCS San Raffaele
Address [18] 0 0
Country [18] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine the effects of daily feedback about physical
activity (number of bouts of walking, duration of bouts, total walking distance, average and
fastest walking speed) and walking average speed compared to feedback about walking speed
only on walking-related outcomes during inpatient rehabilitation for stroke. For the first
time, daily walking and other exercise will be monitored by bilateral triaxial accelerometers
on the ankles. Activity-recognition algorithms will analyze the inpatient sensor data and
return a summary to the participants at each site.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01246882
Trial related presentations / publications
Dobkin BH, Dorsch A. The promise of mHealth: daily activity monitoring and outcome assessments by wearable sensors. Neurorehabil Neural Repair. 2011 Nov-Dec;25(9):788-98. doi: 10.1177/1545968311425908.
Public notes

Contacts
Principal investigator
Name 0 0
Bruce H Dobkin, MD
Address 0 0
University of California, Los Angeles
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01246882