Hybrid Robot+FES Stroke Rehablitation

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04550728
• Other study ID #: HP-00089895
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: November 2023
• Source: University of Maryland, Baltimore
• Contact: Li-qun Zhang, PhD
• Phone: 410 706 2145
• Email: L-Zhang[@]som.umaryland.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2026
• Est. primary completion date: October 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Maryland School of Medicine	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Lower Extremity	The assessment is a measure of lower extremity (LE) motor and sensory impairments post-stroke.	Baseline
Primary	Fugl-Meyer Lower Extremity	The assessment is a measure of lower extremity (LE) motor and sensory impairments post-stroke.	6 weeks
Primary	Fugl-Meyer Lower Extremity	The assessment is a measure of lower extremity (LE) motor and sensory impairments post-stroke.	12 weeks
Primary	Dorsiflexion active range of motion	Joint ankle active range of motion measured by ankle robot.	Baseline
Primary	Dorsiflexion active range of motion	Joint ankle active range of motion measured by ankle robot.	6 weeks
Primary	Dorsiflexion active range of motion	Joint ankle active range of motion measured by ankle robot.	12 weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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