Clinical trial NCT04550728: Hybrid Robot+FES Stroke Rehabilitation
Official title: Assessment Followed by Home-based Hybrid Robot + FES Rehabilitation Post-stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: stroke
functional electrical stimulation
robot training
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Fugl-Meyer Lower Extremity
timeFrame: Baseline
measure: Fugl-Meyer Lower Extremity
timeFrame: 6 weeks
measure: Fugl-Meyer Lower Extremity
timeFrame: 12 weeks
measure: Dorsiflexion active range of motion
timeFrame: Baseline
measure: Dorsiflexion active range of motion
timeFrame: 6 weeks
measure: Dorsiflexion active range of motion
timeFrame: 12 weeks
measure: 6 minutes walking test
timeFrame: Baseline
measure: 6 minutes walking test
timeFrame: 6 weeks
measure: 6 minutes walking test
timeFrame: 12 weeks
measure: Medical thickness of medial gastrocnemius muscle and tibial anterior muscle
timeFrame: Baseline
measure: Medical thickness of medial gastrocnemius muscle and tibial anterior muscle
timeFrame: 6 week
measure: Medical thickness of medial gastrocnemius muscle and tibial anterior muscle
timeFrame: 12 week
measure: Muscle fiber pennation angle of medial gastrocnemius muscle and tibial anterior muscle
timeFrame: Baseline
measure: Muscle fiber pennation angle of medial gastrocnemius muscle and tibial anterior muscle
timeFrame: 6 week
measure: Muscle fiber pennation angle of medial gastrocnemius muscle and tibial anterior muscle
timeFrame: 12 week
Secondary outcomes:
measure: Timed up-to-go
timeFrame: Baseline
measure: Timed up-to-go
timeFrame: 6 weeks
measure: Timed up-to-go
timeFrame: 12 weeks
measure: Stroke Rehabilitation Assessment of Movement (STREAM)
timeFrame: baseline
measure: Stroke Rehabilitation Assessment of Movement (STREAM)
timeFrame: 6 weeks
measure: Stroke Rehabilitation Assessment of Movement (STREAM)
timeFrame: 12 weeks
measure: Brief Balance Evaluation Systems Test(Brief-BESTest)
timeFrame: baseline
measure: Brief Balance Evaluation Systems Test(Brief-BESTest)
timeFrame: 6 weeks
measure: Brief Balance Evaluation Systems Test(Brief-BESTest)
timeFrame: 12 weeks
measure: Modified Ashworth Scale (MAS)
timeFrame: baseline
measure: Modified Ashworth Scale (MAS)
timeFrame: 6 weeks
measure: Modified Ashworth Scale (MAS)
timeFrame: 12 weeks
measure: 10-meter walk test (10MWT)
timeFrame: baseline
measure: 10-meter walk test (10MWT)
timeFrame: 6 weeks
measure: 10-meter walk test (10MWT)
timeFrame: 12 weeks
measure: Stiffness of medial gastrocnemius muscle and tibial anterior muscle.
timeFrame: Baseline
measure: Stiffness of medial gastrocnemius muscle and tibial anterior muscle.
timeFrame: 6 weeks
measure: Stiffness of medial gastrocnemius muscle and tibial anterior muscle.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
Study officials:
References:
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.
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.
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.
citation: 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.