Hybrid Robot+FES Stroke Rehabilitation

Official title

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

Overview

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.

Interventions

• 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.
• 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.

Primary outcome measures

• Fugl-Meyer Lower Extremity [Time frame: Baseline]
• Fugl-Meyer Lower Extremity [Time frame: 6 weeks]
• Fugl-Meyer Lower Extremity [Time frame: 12 weeks]
• Dorsiflexion active range of motion [Time frame: Baseline]
• Dorsiflexion active range of motion [Time frame: 6 weeks]
• Dorsiflexion active range of motion [Time frame: 12 weeks]
• 6 minutes walking test [Time frame: Baseline]
• 6 minutes walking test [Time frame: 6 weeks]
• 6 minutes walking test [Time frame: 12 weeks]
• Medical thickness of medial gastrocnemius muscle and tibial anterior muscle [Time frame: Baseline]

Secondary outcome measures (12)

• Timed up-to-go [Time frame: Baseline]
• Timed up-to-go [Time frame: 6 weeks]
• Timed up-to-go [Time frame: 12 weeks]
• Stroke Rehabilitation Assessment of Movement (STREAM) [Time frame: baseline]
• Stroke Rehabilitation Assessment of Movement (STREAM) [Time frame: 6 weeks]
• Stroke Rehabilitation Assessment of Movement (STREAM) [Time frame: 12 weeks]
• Brief Balance Evaluation Systems Test(Brief-BESTest) [Time frame: baseline]
• Brief Balance Evaluation Systems Test(Brief-BESTest) [Time frame: 6 weeks]
• Brief Balance Evaluation Systems Test(Brief-BESTest) [Time frame: 12 weeks]
• Modified Ashworth Scale (MAS) [Time frame: baseline]
• Modified Ashworth Scale (MAS) [Time frame: 6 weeks]
• Modified Ashworth Scale (MAS) [Time frame: 12 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Maryland School of Medicine — Baltimore

Publications

• 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
• 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
• 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
• 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

Identifiers

NCT: NCT04550728 · HP-00089895

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗