Stroke
Conditions
Brief summary
The purpose of this study is to compare 2 training programs using robotic exercise devices to supervised arm exercises in stroke patients with chronic stable deficits.
Detailed description
A robotic exercise device has been developed(MIT-MANUS)capable of providing therapy to the arm for patients with weakness due to stroke. The randomized trial will compare conventional care, planar robot intervention and an intervention of planar and vertical robot training among patients with chronic, stable deficits. We will evaluate motor outcomes, effectiveness, cost, patient satisfaction and quality of life. The study will determine the efficacy of upper extremity robot therapy compared to supervised self-administered exercise therapy in patients with deficits due to stroke.
Interventions
DEVICERobotic Upper Extremity Neurorehabilitation
Upper extremity exercise using a planar robot Upper extremity exercise using a planar and vertical robot
OTHERTraditional Upper Extremity Exercise Group
Upper extremity stretching, skateboard reaching activities, and arm ergometer
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must have a clinically, defined, unilateral, hemiparetic stroke with radiologic exclusion of other diagnoses * Stroke onset greater than six months before randomization for ischemic stroke patients and one year before randomization for hemorrhagic stroke patients * A grade 3 or lower in Manual Muscle Test in the hemiparetic elbow flexion and shoulder abduction
Exclusion criteria
* Subjects unable to give informed consent * Serious complicating medical illness * Contracture or orthopedic problems limiting the range of joint movement in the study arm * Visual loss * Stroke occurred within 6 months for ischemic stroke patients, one year for hemorrhagic patients * Botox treatment within 3 months of enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Upper Extremity Portion of the Fugl-Meyer Motor Performance Assessment | Baseline to Final Training (6 weeks) | The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia (Fugl-Meyer, Jaasko, Leyman, Olsson, & Steglind, 1975; Gladstone, Danells, & Black, 2002). Sections can be administered separately and the upper extremity motor portion of this measure was used as our primary outcome. Assessment items included movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, and hand. These items were scored on the basis of ability to complete using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible score for the upper extremity is 66 with a minimum range of 0 and maximum of 66. A higher score indicates a better outcome. |
Countries
United States
Participant flow
Recruitment details
147 community-dwelling adults with a diagnosis of chronic stroke were referred for study criteria screening by local VA stroke clinics and PT/OT clinicians. Community study advertisements and flyers were also utulized during this recruitment period that started October 2006 and ended December 2009.
Pre-assignment details
Participants were excluded prior to randomization if they did not meet inclusion/exclusion criteria. Some candidates declined after learning of the study length and schedule committment.
Participants by arm
| Arm | Count |
|---|---|
| Planar Robot Robot-assisted planar reaching x 60 minutes. | 20 |
| Planar + Vertical Robot Robot-assisted planar and robot-assisted vertical reaching x 60 minutes. | 21 |
| Intensive Conventional Exercise Upper extremity stretching, skateboard reaching activities, range of motion, and arm ergometer training x 60 minutes. | 21 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 1 |
| Overall Study | Lost to Follow-up | 2 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 3 | 1 |
Baseline characteristics
| Characteristic | Planar Robot | Planar + Vertical Robot | Intensive Conventional Exercise | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 4 Participants | 2 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 17 Participants | 19 Participants | 52 Participants |
| Age, Continuous | 57 years STANDARD_DEVIATION 12 | 60 years STANDARD_DEVIATION 13 | 56 years STANDARD_DEVIATION 6.3 | 57 years STANDARD_DEVIATION 11 |
| Fugl-Meyer Upper Extremity Motor Assessment | 20.3 units on a scale STANDARD_DEVIATION 14.7 | 16.5 units on a scale STANDARD_DEVIATION 10.6 | 18.2 units on a scale STANDARD_DEVIATION 12.5 | 18.0 units on a scale STANDARD_DEVIATION 12.5 |
| Region of Enrollment United States | 20 participants | 21 participants | 21 participants | 62 participants |
| Sex: Female, Male Female | 8 Participants | 9 Participants | 11 Participants | 28 Participants |
| Sex: Female, Male Male | 12 Participants | 12 Participants | 10 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 20 | 1 / 21 | 1 / 21 |
| serious Total, serious adverse events | 0 / 20 | 0 / 21 | 0 / 21 |
Outcome results
Primary
Upper Extremity Portion of the Fugl-Meyer Motor Performance Assessment
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia (Fugl-Meyer, Jaasko, Leyman, Olsson, & Steglind, 1975; Gladstone, Danells, & Black, 2002). Sections can be administered separately and the upper extremity motor portion of this measure was used as our primary outcome. Assessment items included movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, and hand. These items were scored on the basis of ability to complete using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible score for the upper extremity is 66 with a minimum range of 0 and maximum of 66. A higher score indicates a better outcome.
Time frame: Baseline to Final Training (6 weeks)
Population: The number of participants analyzed were based on an intention to treat methodology with the exception of individuals that were non-compliant with the protocol or did not progress to the midpoint (3 week) evaluation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Planar Robot | Upper Extremity Portion of the Fugl-Meyer Motor Performance Assessment | 3.27 units on a scale | Standard Deviation 3.27 |
| Planar + Vertical | Upper Extremity Portion of the Fugl-Meyer Motor Performance Assessment | 2.51 units on a scale | Standard Deviation 3.33 |
| Intensive Conventional Exercise | Upper Extremity Portion of the Fugl-Meyer Motor Performance Assessment | 1.82 units on a scale | Standard Deviation 4.24 |
Comparison: An analysis of all robot interventions compared with intensive conventional exercise for Fugl-Meyer change were completed using linear mixed models.p-value: 0.025Mixed Models Analysis