Stroke Inpatient Rehabilitation Reinforcement of ACTivity

NCT ID: NCT01246882

Last Updated: 2019-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-11-30

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.

Detailed Description

Wireless Sensor System The inertial sensor system and activity-recognition algorithms were previously described and tested for short-term reliability. Three sets of triaxial accelerometers (Gulf Coast Data Concepts, Waveland, MS) were mailed to each site's coordinator. Therapists placed one sensor on each ankle before participants got out of bed each morning and removed them once they were in bed at the end of the day; sensor use during weekends was optional. A soft snap band secured each sensor proximal to the medial malleolus, flush against the bony tibia. Every night, sensors were plugged into a local computer to recharge while accelerometer data were uploaded to the central server at UCLA for secure storage and processing. Sensor Calibration and Data Processing In recognition of the variations in gait speed and stand and swing symmetry that occur in patients who need inpatient rehabilitation after stroke, we chose to generate individual templates of each participant's gait from a pair of standardized walks. On study entry participants performed two stopwatch- timed 10-meter walks at self-selected casual and safest fast walking speeds. A hybrid classifier employing dynamic time warping and Naïve Bayes algorithms generated statistical models of each participant's gait based on the two walks. Repeat walks were performed and the templates updated weekly for the remainder of each participant's rehabilitation stay to account for expected changes in gait parameters.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Augmented activity feedback

Intervention Type: BEHAVIORAL

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.

speed-only feedback

Feedback three times per week about overground walking speed over 10 meters.

Group Type: ACTIVE_COMPARATOR

Speed-only feedback

Intervention Type: BEHAVIORAL

Feedback about walking speed will be provided 3 times per week.

Interventions

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.

Intervention Type: BEHAVIORAL

Speed-only feedback

Feedback about walking speed will be provided 3 times per week.

Intervention Type: BEHAVIORAL

Other Intervention Names

accelerometry; hemiparetic stroke; mobile health; wireless health; feedback about performance; physical therapy for stroke rehabilitation; locomotion

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: collaborator

University of Vigo

OTHER

Sponsor Role: collaborator

Morinomiya Hospital, Osaka, Japan

UNKNOWN

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: collaborator

IRCCS San Camillo, Venezia, Italy

OTHER

Sponsor Role: collaborator

Fairlawn Hospital, Worcester, MA, USA

UNKNOWN

Sponsor Role: collaborator

Chonnam National University Hospital

OTHER

Sponsor Role: collaborator

Ain Shams University

OTHER

Sponsor Role: collaborator

MedStar National Rehabilitation Network

OTHER

Sponsor Role: collaborator

St. Luke's Hospital, Pennsylvania

OTHER

Sponsor Role: collaborator

Father Muller Medical College

OTHER

Sponsor Role: collaborator

Burke Rehabilitation Hospital

OTHER

Sponsor Role: collaborator

Burwood Hospital, Christchurch, New Zealand

OTHER

Sponsor Role: collaborator

Gazi University

OTHER

Sponsor Role: collaborator

University College Hospital, Ibadan, Nigeria

UNKNOWN

Sponsor Role: collaborator

Rehabilitation Hospital, Barcelona, Spain

UNKNOWN

Sponsor Role: collaborator

IRCCS San Raffaele

OTHER

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Bruce H. Dobkin

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bruce H Dobkin, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

Fairlawn Hospital

Worcester, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University

St Louis, Missouri, United States

Burke Rehabilitation Hospital

White Plains, New York, United States

St. Luke's Hospital

Allentown, Pennsylvania, United States

Ain Shams University

Cairo, , Egypt

Father Muller Medical College

Karnataka, , India

National Rehabilitation Hospital

Dublin, , Ireland

San Raffaele Hospital

Milan, , Italy

Sam Camillo

Venice, , Italy

Morinomiya Hospital

Osaka, , Japan

Burwood Hospital

Christchurch, , New Zealand

Univeristy College Hospital

Ibadan, , Nigeria

Chonnam National Hospital

Gwangju, , South Korea

Rehabilitation Hospital

Barcelona, , Spain

University of Vigo

Vigo, , Spain

National Taiwan University Hospital

Taipei, , Taiwan

Gazi University

Ankara, , Turkey (Türkiye)

Countries

United States; Egypt; India; Ireland; Italy; Japan; New Zealand; Nigeria; South Korea; Spain; Taiwan; Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 21989632 (View on PubMed)

Dorsch AK, Thomas S, Xu X, Kaiser W, Dobkin BH; SIRRACT investigators. SIRRACT: An International Randomized Clinical Trial of Activity Feedback During Inpatient Stroke Rehabilitation Enabled by Wireless Sensing. Neurorehabil Neural Repair. 2015 Jun;29(5):407-15. doi: 10.1177/1545968314550369. Epub 2014 Sep 26.

Reference Type: RESULT

PMID: 25261154 (View on PubMed)

Other Identifiers

10-000134

Identifier Type: -

Identifier Source: org_study_id