Hybrid Robot+FES Stroke Rehablitation

Assessment Followed by Home-based Hybrid Robot + FES Rehabilitation Post-stroke

The investigators have developed a novel robot-guided stretching under intelligent control and combine it with active movement training, which helped increase joint ROM, reduce spasticity and joint stiffness, increase muscle force output, and improve locomotion. However, for stroke survivors with sensorimotor impairment, their peripheral muscle may not sufficiently be recruited. Functional electrical stimulation (FES), has been shown its advantage to activate the peripheral muscles for people with neurological conditions. The investigators thus make a hybrid robot-FES rehabilitation system, combining the advantage of robot and FES technologies for stroke motor recovery. The investigators further would like to translate the technologies from lab to home-based training. Thus, the investigators will conduct a randomized, controlled, primarily home-based clinical trial using an ankle robot alone or combined with functional electrical stimulation (FES) to treat sensorimotor and locomotion impairments post-stroke.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Combination product: Ankle robot training and functional electrical stimulation(FES) group; Combination product: Ankle robot training group

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Li-qun Zhang, PhD; Phone Number: 410 706 2145; Email: L-Zhang@som.umaryland.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • University of Maryland School of Medicine
      • Contact: Li-Qun Zhang, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18-85;
• Able to ambulate at least 10 meters without human assistance, with or without an assistive device
• ≥ 6 months post stroke;
• having a caregiver to assist in training at home.

Exclusion Criteria:

• having expressive and receptive aphasia;
• an inability to follow multi-step commands;
• enrolled in another lower limb rehabilitation program;
• having severe pain in the paralyzed lower-limb;
• >30º ankle plantar flexion contracture;
• Having implanted electronic device such as a pacemaker, spinal cord, or deep brain stimulator because FES may potentially interfere with their functions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FES+robot; Participants in this group will have FES during ankle robot training	Combination product: Ankle robot training and functional electrical stimulation(FES) group; Patients will use the ankle robot device as the ankle training group. Also, water-based FES electrodes positioned inside a soft garment will be secured over the DF and PF muscles by wrapping the garment around the leg just below the knee joint. Stimulation intensity will be increased to maximal tolerance of each participant. Electrically induced contraction timing will be triggered by the ankle robot in synchrony with the ankle dorsi and plantar flexion movements.
Active Comparator: Robot; Participants in this group will have ankle robot training only	Combination product: Ankle robot training group; Patients will be seated with the paretic foot strapped to the footplate the knee at full extension. The operator will set up and measure (using the robot) ankle passive DF and PF ROM limits. The robot training will include passive stretching, robot interactive game-based training, and cool-down stretching.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl-Meyer Lower Extremity	The assessment is a measure of lower extremity (LE) motor and sensory impairments post-stroke.	Baseline
Fugl-Meyer Lower Extremity	The assessment is a measure of lower extremity (LE) motor and sensory impairments post-stroke.	6 weeks
Fugl-Meyer Lower Extremity	The assessment is a measure of lower extremity (LE) motor and sensory impairments post-stroke.	12 weeks
Dorsiflexion active range of motion	Joint ankle active range of motion measured by ankle robot.	Baseline
Dorsiflexion active range of motion	Joint ankle active range of motion measured by ankle robot.	6 weeks
Dorsiflexion active range of motion	Joint ankle active range of motion measured by ankle robot.	12 weeks
6 minutes walking test	The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.	Baseline
6 minutes walking test	The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.	6 weeks
6 minutes walking test	The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.	12 weeks
Medical thickness of medial gastrocnemius muscle and tibial anterior muscle	B-model ultrasound will be used to scan the muscle thickness, and the image will be further proceeded to measure the muscle thickness with unit in centimetres.	Baseline
Medical thickness of medial gastrocnemius muscle and tibial anterior muscle	B-model ultrasound will be used to scan the muscle thickness, and the image will be further proceeded to measure the muscle thickness with unit in centimetres.	6 week
Medical thickness of medial gastrocnemius muscle and tibial anterior muscle	B-model ultrasound will be used to scan the muscle thickness, and the image will be further proceeded to measure the muscle thickness with unit in centimetres.	12 week
Muscle fiber penation angle of medial gastrocnemius muscle and tibial anterior muscle	B-model ultrasound will be used to scan the muscle and the image will be further proceeded to measure the muscle fiber penation angle with unit in degree.	Baseline
Muscle fiber penation angle of medial gastrocnemius muscle and tibial anterior muscle	B-model ultrasound will be used to scan the muscle and the image will be further proceeded to measure the muscle fiber penation angle with unit in degree.	6 week
Muscle fiber penation angle of medial gastrocnemius muscle and tibial anterior muscle	B-model ultrasound will be used to assess the muscle thickness, muscle fiber pennation angle. Elasticity will be measured using ultrasound elastography.	12 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timed up-to-go	The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.	Baseline
Timed up-to-go	The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.	6 weeks
Timed up-to-go	The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.	12 weeks
Stroke Rehabilitation Assessment of Movement (STREAM)	Stroke Rehabilitation Assessment of Movement Measure (STREAM) provides therapists with a quantitative measurement of motor functioning and basic mobility deficits among patients who had a stroke through the performance of 30 voluntary motor tasks of the upper extremities (UE) and lower extremities (LE).	baseline
Stroke Rehabilitation Assessment of Movement (STREAM)	Stroke Rehabilitation Assessment of Movement Measure (STREAM) provides therapists with a quantitative measurement of motor functioning and basic mobility deficits among patients who had a stroke through the performance of 30 voluntary motor tasks of the upper extremities (UE) and lower extremities (LE).	6 weeks
Stroke Rehabilitation Assessment of Movement (STREAM)	Stroke Rehabilitation Assessment of Movement Measure (STREAM) provides therapists with a quantitative measurement of motor functioning and basic mobility deficits among patients who had a stroke through the performance of 30 voluntary motor tasks of the upper extremities (UE) and lower extremities (LE).	12 weeks
Brief Balance Evaluation Systems Test(Brief-BESTest)	The Brief BESTest is a clinical balance assessment tool. It is an abbreviated version of Balance Evaluation Systems Test (BESTest), designed to assess 6 different aspects contributing to postural control in standing and walking.	baseline
Brief Balance Evaluation Systems Test(Brief-BESTest)	The Brief BESTest is a clinical balance assessment tool. It is an abbreviated version of Balance Evaluation Systems Test (BESTest), designed to assess 6 different aspects contributing to postural control in standing and walking.	6 weeks
Brief Balance Evaluation Systems Test(Brief-BESTest)	The Brief BESTest is a clinical balance assessment tool. It is an abbreviated version of Balance Evaluation Systems Test (BESTest), designed to assess 6 different aspects contributing to postural control in standing and walking.	12 weeks
Modified Ashworth Scale (MAS)	The Modified Ashworth Scale is the most widely used assessment tool to measure resistance to limb movement in a clinic setting. Scores range from 0-4, with 6 choices. 0 (0) - No increase in muscle tone; 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension; 1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of movement (ROM); 2 (3) - More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved; 3 (4) - Considerable increase in muscle tone passive, movement difficult; 4 (5) - Affected part(s) rigid in flexion or extension.	baseline
Modified Ashworth Scale (MAS)	The Modified Ashworth Scale is the most widely used assessment tool to measure resistance to limb movement in a clinic setting. Scores range from 0-4, with 6 choices. 0 (0) - No increase in muscle tone; 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension; 1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of movement (ROM); 2 (3) - More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved; 3 (4) - Considerable increase in muscle tone passive, movement difficult; 4 (5) - Affected part(s) rigid in flexion or extension.	6 weeks
Modified Ashworth Scale (MAS)	The Modified Ashworth Scale is the most widely used assessment tool to measure resistance to limb movement in a clinic setting. Scores range from 0-4, with 6 choices. 0 (0) - No increase in muscle tone; 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension; 1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of movement (ROM); 2 (3) - More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved; 3 (4) - Considerable increase in muscle tone passive, movement difficult; 4 (5) - Affected part(s) rigid in flexion or extension.	12 weeks
10-meter walk test (10MWT)	The 10 Metre Walk Test is a performance measure used to assess walking speed in metres per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function.	baseline
10-meter walk test (10MWT)	The 10 Metre Walk Test is a performance measure used to assess walking speed in metres per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function.	6 weeks
10-meter walk test (10MWT)	The 10 Metre Walk Test is a performance measure used to assess walking speed in metres per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function.	12 weeks
Stiffness of medial gastrocnemius muscle and tibial anterior muscle.	Supersonic shear wave elastography will be used to estimate the shear wave speed(m/s) of the muscles.	Baseline
Stiffness of medial gastrocnemius muscle and tibial anterior muscle.	Supersonic shear wave elastography will be used to estimate the shear wave speed(m/s) of the muscles.	6 weeks
Stiffness of medial gastrocnemius muscle and tibial anterior muscle.	Supersonic shear wave elastography will be used to estimate the shear wave speed(m/s) of the muscles.	12 weeks

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore

Publications and helpful links

General Publications

• Selles RW, Li X, Lin F, Chung SG, Roth EJ, Zhang LQ. Feedback-controlled and programmed stretching of the ankle plantarflexors and dorsiflexors in stroke: effects of a 4-week intervention program. Arch Phys Med Rehabil. 2005 Dec;86(12):2330-6. doi: 10.1016/j.apmr.2005.07.305.
• Zhang LQ, Chung SG, Bai Z, Xu D, van Rey EM, Rogers MW, Johnson ME, Roth EJ. Intelligent stretching of ankle joints with contracture/spasticity. IEEE Trans Neural Syst Rehabil Eng. 2002 Sep;10(3):149-57. doi: 10.1109/TNSRE.2002.802857.
• Ren Y, Wu YN, Yang CY, Xu T, Harvey RL, Zhang LQ. Developing a Wearable Ankle Rehabilitation Robotic Device for in-Bed Acute Stroke Rehabilitation. IEEE Trans Neural Syst Rehabil Eng. 2017 Jun;25(6):589-596. doi: 10.1109/TNSRE.2016.2584003. Epub 2016 Jun 22.
• Embrey DG, Holtz SL, Alon G, Brandsma BA, McCoy SW. Functional electrical stimulation to dorsiflexors and plantar flexors during gait to improve walking in adults with chronic hemiplegia. Arch Phys Med Rehabil. 2010 May;91(5):687-96. doi: 10.1016/j.apmr.2009.12.024.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: September 3, 2020
• First Submitted That Met QC Criteria: September 10, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Actual): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 8, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: stroke; functional electrical stimulation; robot training
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: HP-00089895

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No