search
Back to results

Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
REACH robotic training and multi-muscle Functional Electrical Stimulation (FES) group
Robot only group
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke Rehabilitation, Robotic Rehabilitation, Functional Electrical Stimulation

Eligibility Criteria

22 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Individuals with chronic stroke(>6months post stroke) Age-22-85 years old Ability to perform a Upper Extremity forward reach of about 3 inches Exclusion Criteria: 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

Sites / Locations

  • University of Maryland School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hybrid multi-muscle FES+Robot

Robot only

Arm Description

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.

Participants will receive upper extremity training with the REACH robotic device. The training will be a multi-directional reach movement re-training.

Outcomes

Primary Outcome Measures

Kinematic Assessment:Smoothness in 1/s2
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
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
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

Fugl-Meyer Upper Extremity(FMA-UE)
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)
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)
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(completing time of the task) and WMFT-FAS(functional abilities of the paretic upper extremity). 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.

Full Information

First Posted
April 18, 2023
Last Updated
October 3, 2023
Sponsor
University of Maryland, Baltimore
search

1. Study Identification

Unique Protocol Identification Number
NCT05854485
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 3, 2023 (Anticipated)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
April 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke Rehabilitation, Robotic Rehabilitation, Functional Electrical Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hybrid multi-muscle FES+Robot
Arm Type
Experimental
Arm Description
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.
Arm Title
Robot only
Arm Type
Active Comparator
Arm Description
Participants will receive upper extremity training with the REACH robotic device. The training will be a multi-directional reach movement re-training.
Intervention Type
Combination Product
Intervention Name(s)
REACH robotic training and multi-muscle Functional Electrical Stimulation (FES) group
Intervention Description
Participants in this group will receive multi-muscle FES during arm robotic training
Intervention Type
Combination Product
Intervention Name(s)
Robot only group
Intervention Description
Participants in this group will receive arm robotic training only
Primary Outcome Measure Information:
Title
Kinematic Assessment:Smoothness in 1/s2
Description
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.
Time Frame
Change from Baseline Smoothness at 6 weeks
Title
Kinematic Assessment:Speed in cm/seconds
Description
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.
Time Frame
Change from Baseline Speed at 6 weeks
Title
Kinematic Assessment:Range of Motion(ROM) in cms
Description
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.
Time Frame
Change from Baseline ROM at 6 weeks
Secondary Outcome Measure Information:
Title
Fugl-Meyer Upper Extremity(FMA-UE)
Description
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.
Time Frame
Change from Baseline FMA-UE at 6 weeks
Title
Modified Ashworth Scale of muscle spasticity (MAS)
Description
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.
Time Frame
Change from Baseline MAS at 6 weeks
Title
Wolf Motor Function Test (WMFT)
Description
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(completing time of the task) and WMFT-FAS(functional abilities of the paretic upper extremity). 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.
Time Frame
Change from Baseline WMFT at 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals with chronic stroke(>6months post stroke) Age-22-85 years old Ability to perform a Upper Extremity forward reach of about 3 inches Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sanjana Rao
Phone
4438256349
Email
sanjana.rao@som.umaryland.edu
Facility Information:
Facility Name
University of Maryland School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanjana Rao

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27692878
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.
Results Reference
background
PubMed Identifier
19190087
Citation
Hughes AM, Freeman CT, Burridge JH, Chappell PH, Lewin PL, Rogers E. Feasibility of iterative learning control mediated by functional electrical stimulation for reaching after stroke. Neurorehabil Neural Repair. 2009 Jul-Aug;23(6):559-68. doi: 10.1177/1545968308328718. Epub 2009 Feb 3.
Results Reference
background
PubMed Identifier
31068898
Citation
Duret C, Grosmaire AG, Krebs HI. Robot-Assisted Therapy in Upper Extremity Hemiparesis: Overview of an Evidence-Based Approach. Front Neurol. 2019 Apr 24;10:412. doi: 10.3389/fneur.2019.00412. eCollection 2019.
Results Reference
background
PubMed Identifier
16790067
Citation
Kahn LE, Zygman ML, Rymer WZ, Reinkensmeyer DJ. Robot-assisted reaching exercise promotes arm movement recovery in chronic hemiparetic stroke: a randomized controlled pilot study. J Neuroeng Rehabil. 2006 Jun 21;3:12. doi: 10.1186/1743-0003-3-12.
Results Reference
background
PubMed Identifier
18184932
Citation
Volpe BT, Lynch D, Rykman-Berland A, Ferraro M, Galgano M, Hogan N, Krebs HI. Intensive sensorimotor arm training mediated by therapist or robot improves hemiparesis in patients with chronic stroke. Neurorehabil Neural Repair. 2008 May-Jun;22(3):305-10. doi: 10.1177/1545968307311102. Epub 2008 Jan 9.
Results Reference
background
PubMed Identifier
31180833
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.
Results Reference
background
PubMed Identifier
29988530
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.
Results Reference
background
PubMed Identifier
24312073
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.
Results Reference
background
PubMed Identifier
28265148
Citation
Moon SH, Choi JH, Park SE. The effects of functional electrical stimulation on muscle tone and stiffness of stroke patients. J Phys Ther Sci. 2017 Feb;29(2):238-241. doi: 10.1589/jpts.29.238. Epub 2017 Feb 24.
Results Reference
background

Learn more about this trial

Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke

We'll reach out to this number within 24 hrs