Clinical trial NCT01144715: Rehabilitation of the Stroke Hand at Home
Official title: An Innovative Home Stroke Rehabilitation and Monitoring System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stroke
Keywords: Stroke Rehabilitation
Home rehabilitation
robotic therapy
Lead sponsor: Kinetic Muscles
Sponsor class: INDUSTRY
Collaborators: name: The Cleveland Clinic
name: Emory University
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2010-06-16
Enrollment: 99
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to evaluate a therapy delivery system for stroke patients that provide accessible, affordable stroke care. User-friendly home therapy robots and a telerehabilitation system are combined to monitor and provide therapy that is accessible for patients in rural and underserved locations. The robotic-based home therapy intervention will produce significantly greater improvement in upper extremity motor function than Usual and Customary Care enhanced with a (non-robotic) home therapy upper extremity rehabilitation program at the end of 8 weeks of home therapy.

Detailed description: The primary purpose of this proposal is to evaluate a combined clinic/home robotic-based stroke therapy delivery and monitoring system in rural and underserved locations that provides accessible, effective and affordable care for stroke survivors with residual limb impairment. The study is a prospective, single-blind, multi-site Randomized Controlled Trial. A total of 96 patients within 6 months post-stroke will be enrolled and randomly assigned to one of two groups: robotic based home therapy or a self administered (non-robotic) home therapy program.

Eligibility criteria: Inclusion Criteria:

* Unilateral ischemic or hemorrhagic stroke
* within 6 months of admission to in-patient rehabilitation
* Persistent hemiparesis
* Proximal Upper Extremity voluntary activity
* Preserved cognitive function
* Difficult access to an organized stroke rehabilitation program

Exclusion Criteria:

* Not independent before stroke
* Hemispatial neglect
* Significant other illnesses

Primary outcomes:
measure: Action Research Arm Test (ARAT)
timeFrame: End of treatment at 8 weeks post enrolment
Secondary outcomes:
measure: Wolf Motor Function Test
timeFrame: End of treatment at 8 weeks post enrolment
measure: Fugl-Meyer Upper Extremity Test
timeFrame: End of Treatment at 8 weeks post enrolment
measure: Stroke Impact Scale (SIS)
timeFrame: End of treatment at 8 weeks post enrolment
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Cleveland
country: United States
facility: Cleveland Clinic Foujndation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Jay Alberts, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University Medical School
name: Steve L Wolf, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Linder SM, Rosenfeldt AB, Bay RC, Sahu K, Wolf SL, Alberts JL. Improving Quality of Life and Depression After Stroke Through Telerehabilitation. Am J Occup Ther. 2015 Mar-Apr;69(2):6902290020p1-10. doi: 10.5014/ajot.2015.014498.
citation: Wolf SL, Sahu K, Bay RC, Buchanan S, Reiss A, Linder S, Rosenfeldt A, Alberts J. The HAAPI (Home Arm Assistance Progression Initiative) Trial: A Novel Robotics Delivery Approach in Stroke Rehabilitation. Neurorehabil Neural Repair. 2015 Nov-Dec;29(10):958-68. doi: 10.1177/1545968315575612. Epub 2015 Mar 17.
citation: Linder SM, Rosenfeldt AB, Reiss A, Buchanan S, Sahu K, Bay CR, Wolf SL, Alberts JL. The home stroke rehabilitation and monitoring system trial: a randomized controlled trial. Int J Stroke. 2013 Jan;8(1):46-53. doi: 10.1111/j.1747-4949.2012.00971.x.