Rehabilitation of the Stroke Hand at Home
HAAPI
An Innovative Home Stroke Rehabilitation and Monitoring System
2 other identifiers
interventional
99
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 stroke
Started Jun 2010
Typical duration for phase_4 stroke
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 11, 2010
CompletedFirst Posted
Study publicly available on registry
June 16, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedResults Posted
Study results publicly available
November 27, 2014
CompletedNovember 27, 2014
October 1, 2014
3.3 years
June 11, 2010
October 21, 2014
November 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Action Research Arm Test (ARAT)
The amount of recovery of arm-hand function is measured with the Action Research Arm Test (ARAT). The ARAT assesses activity limitations of the upper extremity. It includes 19 items divided into four subscales: grasp, grip, pinch, and gross movement. Scores range from 0-to-57 with a higher score indicating a better outcome.
End of treatment at 8 weeks post enrolment
Secondary Outcomes (3)
Wolf Motor Function Test
End of treatment at 8 weeks post enrolment
Fugl-Meyer Upper Extremity Test
End of Treatment at 8 weeks post enrolment
Stroke Impact Scale (SIS)
End of treatment at 8 weeks post enrolment
Study Arms (2)
Hand Mentor Therapy
EXPERIMENTALUse of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks
Control
ACTIVE COMPARATORSelf administered home therapy program
Interventions
The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance.
Subjects in the control group will be instructed in a self administered home therapy program
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Not independent before stroke
- Hemispatial neglect
- Significant other illnesses
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kinetic Muscleslead
- The Cleveland Cliniccollaborator
- Emory Universitycollaborator
- National Institute of Neurological Disorders and Stroke (NINDS)collaborator
Study Sites (2)
Emory University School of Medicine
Atlanta, Georgia, 30322, United States
Cleveland Clinic Foujndation
Cleveland, Ohio, 44195, United States
Related Publications (3)
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.
PMID: 26122686DERIVEDWolf 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.
PMID: 25782693DERIVEDLinder 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.
PMID: 23280269DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- James Koeneman, PhD
- Organization
- Kinetic Muscles
Study Officials
- PRINCIPAL INVESTIGATOR
Jay Alberts, PhD
The Cleveland Clinic
- PRINCIPAL INVESTIGATOR
Steve L Wolf, PhD
Emory University Medical School
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2010
First Posted
June 16, 2010
Study Start
June 1, 2010
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
November 27, 2014
Results First Posted
November 27, 2014
Record last verified: 2014-10