Stroke
Conditions
Keywords
Stroke Rehabilitation, Robotic Rehabilitation, Functional Electrical Stimulation
Brief summary
The purpose of this clinical trial is to investigate the efficacy of a hybrid-based rehabilitation program for the upper extremity(UE) combining the interventions- Functional Electrical Stimulation (FES) and Robotic rehabilitation in individuals with chronic stroke. The main question it aims to answer is if the Hybrid multi-muscle FES+Robot upper extremity rehabilitation is more effective in improving the upper extremity motor impairments and function as compared to robotic upper extremity training alone.
Detailed description
Individuals with chronic stroke(\> 6months after stroke) will be recruited. All participants will complete clinical and kinematic assessments at 2 time points(baseline and after 6 weeks training). Each participant will receive 18 sessions of 60 minute upper extremity training over 6 weeks. Study participants will be randomly assigned to receive either of the following upper extremity training- 1. Hybrid multi-muscle FES+Robot training group or 2.Robot only training group. The following clinical assessments to measure the motor impairments and functional recovery will be performed: Fugl-Meyer Upper Extremity, Modified Ashworth Scale, and Wolf Motor Function Test. Kinematic assessments will be conducted using the REACH robotic device and the Kinereach/trakStar system. The following kinematic parameters will be collected: Smoothness, Range of Motion, and Speed.
Interventions
COMBINATION_PRODUCTREACH robotic training and multi-muscle Functional Electrical Stimulation (FES) group
Participants in this group will receive multi-muscle FES during arm robotic training
COMBINATION_PRODUCTRobot only group
Participants in this group will receive arm robotic training only
Sponsors
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Individuals with chronic stroke(\>6months post stroke) 2. Age-22-85 years old 3. Ability to perform a Upper Extremity forward reach of about 3 inches
Exclusion criteria
1. Upper Extremity co-morbidities-pain, arthritis, and other neurological disorders 2. Unable to tolerate electrical stimulation 3. Have implants such as pacemaker, spinal cord or deep brain stimulator 4. Have an elbow contracture of greater than 150 degrees 5. Receiving Botox injections within 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Kinematic Assessment:Smoothness in 1/s2 | Change from Baseline Smoothness at 6 weeks | This measure will be collected as the participants performs target reaching out and in movements of the arm. Smoothness will be collected from the REACH robotic device to determine the kinematic changes in the reaching movements. Kinereach/trakStar system will also be utilized to conduct kinematic assessment and determine the translation of training effects into functional upper extremity use. |
| Kinematic Assessment:Speed in cm/seconds | Change from Baseline Speed at 6 weeks | This measure will be collected as the participants performs target reaching out and in movements of the arm. Speed will be collected from the REACH robotic device to determine the kinematic changes in the reaching movements. Kinereach/trakStar system will also be utilized to conduct kinematic assessment and determine the translation of training effects into functional upper extremity use. |
| Kinematic Assessment:Range of Motion(ROM) in cms | Change from Baseline ROM at 6 weeks | This measure will be collected as the participants performs target reaching out and in movements of the arm. ROM will be collected from the REACH robotic device to determine the kinematic changes in the reaching movements. Kinereach/trakStar system will also be utilized to conduct kinematic assessment and determine the translation of training effects into functional upper extremity use. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Upper Extremity(FMA-UE) | Change from Baseline FMA-UE at 6 weeks | FMA-UE is a standard measure for the clinical assessment of motor impairment. FMA mainly evaluates the degree of synergy pattern during volitional movements, along with reflex activity and coordination. It is based on 33 items and scores range from 0 to 66. A higher score means better motor function. |
| Modified Ashworth Scale of muscle spasticity (MAS) | Change from Baseline MAS at 6 weeks | The MAS is a measurement of spasticity across specific muscle groups. The grading of spasticity ranges from 0 to 5 with higher score indicating worse functioning. |
| Wolf Motor Function Test (WMFT) | Change from Baseline WMFT at 6 weeks | WMFT is a function based test designed to measure upper extremity movements and movement speed during functional tasks. The WMFT consists of 17 items, of which 15 measure time to perform functional tasks and 2 strength-based tasks. Two types of scores are recorded during the task:WMFT-TIME(time of the task) and WMFT-FAS (functional abilities). The maximum score of WMFT-TIME is 120 seconds, and a higher score means slower movement. WMFT-FAS is scored from 0 to 5, and a higher score indicates higher level of functional performance, better quality of the paretic upper extremity during the task. |
Countries
United States
Outcome results
None listed