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Completed

NCT Number: NCT01144715

Rehabilitation of the Stroke Hand at Home

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Emory University School of Medicine, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hand Mentor (TM) robotic stroke therapy device

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.

Home Therapy Program

Device

Subjects in the control group will be instructed in a self administered home therapy program

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Kinetic Muscles

Industry

Collaborators

  • Emory University
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • The Cleveland Clinic

Registry information

Official study title

An Innovative Home Stroke Rehabilitation and Monitoring System

Acronym: HAAPI

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jun 16, 2010
Registry last updated
Nov 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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