Hybrid Robot+FES Stroke Rehabilitation

NCT04550728 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: HP-00089895
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Keywords

stroke; functional electrical stimulation; robot training

Outcome Measures

Primary Outcomes (15)

• 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 pennation 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 pennation angle with unit in degree.

  Baseline

• Muscle fiber pennation 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 pennation angle with unit in degree.

  6 week

• Muscle fiber pennation 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 Outcomes (18)

• Timed up-to-go

  Baseline

• Timed up-to-go

  6 weeks

• Timed up-to-go

  12 weeks

• Stroke Rehabilitation Assessment of Movement (STREAM)

  baseline

• Stroke Rehabilitation Assessment of Movement (STREAM)

  6 weeks

Study Arms (2)

FES+robot

EXPERIMENTAL

Participants in this group will have FES during ankle robot training

Combination Product: Ankle robot training and functional electrical stimulation(FES) group

Robot

ACTIVE COMPARATOR

Participants in this group will have ankle robot training only

Combination Product: Ankle robot training group

Interventions

Ankle robot training and functional electrical stimulation(FES) group COMBINATION_PRODUCT

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.

FES+robot

Ankle robot training group COMBINATION_PRODUCT

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.

Robot

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 12503779 BACKGROUND

• 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.

  PMID: 16344031 BACKGROUND

• 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.

  PMID: 27337720 BACKGROUND

• 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.

  PMID: 20434604 BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Central Study Contacts

Li-qun Zhang, PhD

CONTACT

410 706 2145; L-Zhang@som.umaryland.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 16, 2020
• Study Start: August 1, 2021
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)