Stroke
Conditions
Keywords
Stroke Rehabilitation, Home rehabilitation, robotic therapy
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.
Interventions
DEVICEHand 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.
DEVICEHome Therapy Program
Subjects in the control group will be instructed in a self administered home therapy program
Sponsors
The Cleveland Clinic
Emory University
National Institute of Neurological Disorders and Stroke (NINDS)
Kinetic Muscles
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Action Research Arm Test (ARAT) | 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
| Measure | Time frame | Description |
|---|---|---|
| Wolf Motor Function Test | 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 | 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) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hand Mentor Therapy Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks
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. | 51 |
| Control Self administered home therapy program
Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program | 48 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Total | Hand Mentor Therapy | Control |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 25 Participants | 13 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 74 Participants | 38 Participants | 36 Participants |
| Age, Continuous | 57.5 years STANDARD_DEVIATION 13.3 | 54.7 years STANDARD_DEVIATION 12.2 | 59.1 years STANDARD_DEVIATION 14.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 96 Participants | 48 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 48 Participants | 22 Participants | 26 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 48 Participants | 28 Participants | 20 Participants |
| Region of Enrollment United States | 99 participants | 51 participants | 48 participants |
| Sex: Female, Male Female | 35 Participants | 20 Participants | 15 Participants |
| Sex: Female, Male Male | 64 Participants | 31 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 51 | 5 / 48 |
| serious Total, serious adverse events | 0 / 51 | 0 / 48 |
Outcome results
Primary
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.
Time frame: End of treatment at 8 weeks post enrolment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hand Mentor Therapy | Action Research Arm Test (ARAT) | 39.47 units on a scale | Standard Deviation 19.83 |
| Control | Action Research Arm Test (ARAT) | 39.89 units on a scale | Standard Deviation 17.13 |
Secondary
Fugl-Meyer Upper Extremity Test
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.
Time frame: End of Treatment at 8 weeks post enrolment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hand Mentor Therapy | Fugl-Meyer Upper Extremity Test | 43.43 units on a scale | Standard Deviation 15.64 |
| Control | Fugl-Meyer Upper Extremity Test | 42.89 units on a scale | Standard Deviation 14.58 |
Secondary
Stroke Impact Scale (SIS)
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.
Time frame: End of treatment at 8 weeks post enrolment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hand Mentor Therapy | Stroke Impact Scale (SIS) | 49.4 units on a scale | Standard Deviation 33.5 |
| Control | Stroke Impact Scale (SIS) | 57.6 units on a scale | Standard Deviation 28.2 |
Secondary
Wolf Motor Function Test
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.
Time frame: End of treatment at 8 weeks post enrolment
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Hand Mentor Therapy | Wolf Motor Function Test | 8.67 Seconds | Standard Deviation 4.76 |
| Control | Wolf Motor Function Test | 7.92 Seconds | Standard Deviation 3.97 |