Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke
- Conditions
- Stroke
- Interventions
- Combination Product: REACH robotic training and multi-muscle Functional Electrical Stimulation (FES) groupCombination Product: Robot only group
- Registration Number
- NCT05854485
- Lead Sponsor
- University of Maryland, Baltimore
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 24
- Individuals with chronic stroke(>6months post stroke)
- Age-22-85 years old
- Ability to perform a Upper Extremity forward reach of about 3 inches
- Upper Extremity co-morbidities-pain, arthritis, and other neurological disorders
- Unable to tolerate electrical stimulation
- Have implants such as pacemaker, spinal cord or deep brain stimulator
- Have an elbow contracture of greater than 150 degrees
- Receiving Botox injections within 3 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hybrid multi-muscle FES+Robot REACH robotic training and multi-muscle Functional Electrical Stimulation (FES) group Participants will be receive hybrid upper extremity training involving the combination of REACH robotic device and multi-muscle FES. Water based electrodes will be positioned on the Triceps, Anconeus, wrist and finger extensors. Stimulation intensity of FES will be set at the participants tolerance level. The FES induced muscle contraction timing will be triggered in synchrony with the robotic movement. The training will be a multi-directional reach movement and hand opening re-training. Robot only Robot only group Participants will receive upper extremity training with the REACH robotic device. The training will be a multi-directional reach movement re-training.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
Trial Locations
- Locations (1)
University of Maryland School of Medicine
🇺🇸Baltimore, Maryland, United States