Rehabilitation of the Stroke Hand at Home (HAAPI)
|ClinicalTrials.gov Identifier: NCT01144715|
Recruitment Status : Completed
First Posted : June 16, 2010
Results First Posted : November 27, 2014
Last Update Posted : November 27, 2014
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Device: Hand Mentor (TM) robotic stroke therapy device Device: Home Therapy Program||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||99 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||An Innovative Home Stroke Rehabilitation and Monitoring System|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
Experimental: Hand Mentor Therapy
Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks
Device: Hand Mentor (TM) robotic stroke therapy device
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.
Active Comparator: Control
Self administered home therapy program
Device: Home Therapy Program
Subjects in the control group will be instructed in a self administered home therapy program
- Action Research Arm Test (ARAT) [ Time Frame: End of treatment at 8 weeks post enrolment ]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.
- Wolf Motor Function Test [ Time Frame: End of treatment at 8 weeks post enrolment ]The Wolf Motor Function Test (WMFT) is used to measure the degree of function using timed tasks. The WMFT is a 17-item measure used to assess activity limitations of the upper extremity. It is comprised of 2 strength items and 15 timed task performance items. The task performance items begin with the measurement of simple proximal movements and progress to more complex distal and whole limb movements. The WMFT yields two scores: 1) a functional ability score quantifying quality of performance, and 2) a timed score quantifying speed of performance in seconds. A shorter time is better outcome.
- Fugl-Meyer Upper Extremity Test [ Time Frame: End of Treatment at 8 weeks post enrolment ]Upper Extremity neurological impairment will be measured using the Fugl-Meyer Upper Extremity Test (FMA). The FMA is an impairment-based measure consisting of 33 movements with higher scores indicating increased ability of the patient to move out of synergistic patterns toward more isolated movements. Movement quality of the affected UE is compared to the non-affected UE on 0-2 ordinal scale with 0 indicating no movement at all, 1 indicating partial movement of the affected extremity, and 2 indicating movement equivalent to the non-affected UEs. The score ranges from 0-to-66.
- Stroke Impact Scale (SIS) [ Time Frame: End of treatment at 8 weeks post enrolment ]Quality of Life changes are measured with the Stroke Impact Scale questionnaire. The SIS is a self-rated QOL questionnaire that addresses several domains following stroke: physical strength, memory, feelings and emotions, communication, activities of daily living (ADL), mobility, hand use, meaningful activities, and overall percentage recovery from the stroke. We report the Hand Function subscale, which ranges from 0-to-100. A higher score reflects better hand function.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01144715
|United States, Georgia|
|Emory University School of Medicine|
|Atlanta, Georgia, United States, 30322|
|United States, Ohio|
|Cleveland Clinic Foujndation|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Jay Alberts, PhD||The Cleveland Clinic|
|Principal Investigator:||Steve L Wolf, PhD||Emory University Medical School|