Clinical trial NCT05854485: Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke
Official title: Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Stroke Rehabilitation
Robotic Rehabilitation
Functional Electrical Stimulation
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2023-05-11
Enrollment: 24
Sex: ALL
Minimum age (years): 22
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Kinematic Assessment:Smoothness in 1/s2
timeFrame: Change from Baseline Smoothness at 6 weeks
measure: Kinematic Assessment:Speed in cm/seconds
timeFrame: Change from Baseline Speed at 6 weeks
measure: Kinematic Assessment:Range of Motion(ROM) in cms
timeFrame: Change from Baseline ROM at 6 weeks
Secondary outcomes:
measure: Fugl-Meyer Upper Extremity(FMA-UE)
timeFrame: Change from Baseline FMA-UE at 6 weeks
measure: Modified Ashworth Scale of muscle spasticity (MAS)
timeFrame: Change from Baseline MAS at 6 weeks
measure: Wolf Motor Function Test (WMFT)
timeFrame: Change from Baseline WMFT at 6 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
Study officials:
References:
citation: Resquin F, Cuesta Gomez A, Gonzalez-Vargas J, Brunetti F, Torricelli D, Molina Rueda F, Cano de la Cuerda R, Miangolarra JC, Pons JL. Hybrid robotic systems for upper limb rehabilitation after stroke: A review. Med Eng Phys. 2016 Nov;38(11):1279-1288. doi: 10.1016/j.medengphy.2016.09.001. Epub 2016 Sep 29.
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citation: Ambrosini E, Zajc J, Ferrante S, Ferrigno G, Gasperina SD, Bulgheroni M, Baccinelli W, Schauer T, Wiesener C, Russold M, Gfoehler M, Puchinger M, Weber M, Becker S, Krakow K, Immick N, Augsten A, Rossini M, Proserpio D, Gasperini G, Molteni F, Pedrocchi A. A Hybrid Robotic System for Arm Training of Stroke Survivors: Concept and First Evaluation. IEEE Trans Biomed Eng. 2019 Dec;66(12):3290-3300. doi: 10.1109/TBME.2019.2900525. Epub 2019 Jun 5.
citation: Collins KC, Kennedy NC, Clark A, Pomeroy VM. Kinematic Components of the Reach-to-Target Movement After Stroke for Focused Rehabilitation Interventions: Systematic Review and Meta-Analysis. Front Neurol. 2018 Jun 25;9:472. doi: 10.3389/fneur.2018.00472. eCollection 2018.
citation: Turner DL, Ramos-Murguialday A, Birbaumer N, Hoffmann U, Luft A. Neurophysiology of robot-mediated training and therapy: a perspective for future use in clinical populations. Front Neurol. 2013 Nov 13;4:184. doi: 10.3389/fneur.2013.00184.
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