Stroke Inpatient Rehabilitation Reinforcement of ACTivity

• Register: ClinicalTrials.gov
• Last refreshed on: 3 December 2012
• Main ID: NCT01246882
• Date of registration: 22/11/2010
• Primary sponsor: University of California, Los Angeles
• Public title: Stroke Inpatient Rehabilitation Reinforcement of ACTivity SIRRACT
• Scientific title: Stroke Inpatient Rehabilitation Reinforcement of ACTivty: An International Multisite Clinical Trial
• Date of first enrolment: January 2011
• Target sample size: 140
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01246882
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

Egypt, India, Ireland, Italy, Japan, Korea, Republic of, New Zealand, Nigeria, Spain, Taiwan, Turkey, United States

Contacts

• Name: Bruce H Dobkin, MD
• Affiliation: University of California, Los Angeles

Key inclusion & exclusion criteria

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.

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Stroke

Intervention(s)

Behavioral: Speed-only feedback

Behavioral: wireless sensor monitoring of walking-related physical therapy

Primary Outcome(s)

Gait speed [Time Frame: Discharge]

Secondary Outcome(s)

Distance walked in 3 minutes [Time Frame: Discharge]

Secondary ID(s)

10-000134

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ain Shams University

Burke Rehabilitation Hospital

Burwood Hospital, Christchurch, New Zealand

Chonnam National University Hospital

Fairlawn Hospital, Worcester, MA, USA

Father Muller Medical College

Gazi University

IRCCS San Camillo, Venezia, Italy

IRCSS San Raffaele, Milan, Italy

Mayo Clinic

Morinomiya Hospital, Osaka, Japan

National Rehabilitation Hospital

National Taiwan University Hospital

Rehabilitation Hospital, Barcelona, Spain

St. Luke's Hospital, Pennsylvania

University College Hospital, Ibadan, Nigeria

University of Vigo

Washington University School of Medicine