Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
BEHAVIORAL - Augmented activity feedback
BEHAVIORAL - 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.


BEHAVIORAL: 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.

BEHAVIORAL: Speed-only feedback
Feedback about walking speed will be provided 3 times per week.
Intervention code [1] 0 0
BEHAVIORAL
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
Trial website
Trial related presentations / publications
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

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

TypeCitations or Other Details
Journal Dorsch AK, Thomas S, Xu X, Kaiser W, Dobkin BH; SI... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT01246882