Stroke Inpatient Rehabilitation Reinforcement of ACTivity

NCT01246882 | Completed Phase 3 DMC

• 1 other identifier: 10-000134
• Study Type: interventional
• Target: 140
• Locations: 12 countries
• Sites: 18

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.

Conditions

Stroke

Keywords

Stroke, gait, walking, disability; wireless inertial sensing; mobile health

Outcome Measures

Primary Outcomes (1)

• Gait speed

  Discharge

Secondary Outcomes (1)

• Distance walked in 3 minutes

  Discharge

Study Arms (2)

Augmented activity feedback

EXPERIMENTAL

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.

Behavioral: Augmented activity feedback

speed-only feedback

ACTIVE COMPARATOR

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

Behavioral: Speed-only feedback

Interventions

Augmented activity feedback 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.

Also known as: accelerometry, hemiparetic stroke, mobile health, wireless health, feedback about performance, physical therapy for stroke rehabilitation, locomotion

Augmented activity feedback

Speed-only feedback BEHAVIORAL

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

speed-only feedback

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Taiwan University Hospital: collaborator
• Washington University School of Medicine: collaborator
• University of Vigo: collaborator
• Morinomiya Hospital, Osaka, Japan: collaborator
• Mayo Clinic: collaborator
• IRCCS San Camillo, Venezia, Italy: collaborator
• Fairlawn Hospital, Worcester, MA, USA: collaborator
• Chonnam National University Hospital: collaborator
• Ain Shams University: collaborator
• MedStar National Rehabilitation Network: collaborator
• St. Luke's Hospital, Pennsylvania: collaborator
• Father Muller Medical College: collaborator
• Burke Rehabilitation Hospital: collaborator
• Burwood Hospital, Christchurch, New Zealand: collaborator
• Gazi University: collaborator
• University College Hospital, Ibadan, Nigeria: collaborator
• Rehabilitation Hospital, Barcelona, Spain: collaborator
• IRCCS San Raffaele: collaborator

Study Sites (18)

Fairlawn Hospital

Worcester, Massachusetts, 01602, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University

St Louis, Missouri, 63108, United States

Location

Burke Rehabilitation Hospital

White Plains, New York, 10605, United States

Location

St. Luke's Hospital

Allentown, Pennsylvania, 18104, United States

Location

Ain Shams University

Cairo, Egypt

Location

Father Muller Medical College

Karnataka, India

Location

National Rehabilitation Hospital

Dublin, Ireland

Location

San Raffaele Hospital

Milan, Italy

Location

Sam Camillo

Venice, Italy

Location

Morinomiya Hospital

Osaka, Japan

Location

Burwood Hospital

Christchurch, New Zealand

Location

Univeristy College Hospital

Ibadan, Nigeria

Location

Chonnam National Hospital

Gwangju, South Korea

Location

Rehabilitation Hospital

Barcelona, Spain

Location

University of Vigo

Vigo, Spain

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Gazi University

Ankara, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 21989632 BACKGROUND

• 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.

  PMID: 25261154 RESULT

MeSH Terms

Conditions

Stroke

Interventions

Accelerometry; Telemedicine; Physical Therapy Modalities; Stroke Rehabilitation; Locomotion

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques; Delivery of Health Care; Patient Care Management; Health Services Administration; Therapeutics; Rehabilitation; Neurological Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services; Movement; Physiological Phenomena; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Bruce H Dobkin, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 22, 2010
• First Posted: November 23, 2010
• Study Start: January 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: May 1, 2019

Record last verified: 2019-04

Locations

IE (1); JP (1); EG (1); IT (2); IN (1); NG (1); NZ (1); TW (1); KR (1); US (5); ES (2); TU (1)