Sensory-Motor Rehabilitation Post Stroke

Overview

Early after stroke, patients often have significant motor impairment and sensory deficit. Evidence has demonstrated heightened plasticity and significant recovery in the acute phase (first months) post stroke but there has been a lack of effective and practical protocols and devices for early intensive sensorimotor therapy.This research study will conduct a randomized clinical trial of an intensive motor-sensory rehabilitation on patients with acute stroke using a wearable rehabilitation robot. The primary aims are to facilitate sensorimotor recovery, reduce ankle impairments, and improve balance and gait functions. This clinical trial will be conducted on the Study and Control groups of acute stroke survivors.

Detailed description

The study will investigate an early intensive rehabilitation in acute stroke for motor relearning, reducing ankle impairments and improving balance and mobility/locomotion functions.

The acute stroke survivor will be randomly placed into two groups. Subjects in the Study group will receive robot-aided motor relearning under real-time feedback, stretching under intelligent control, sensory stimulation, and active movement training with interactive games. Subjects in the Control group will receive passive movement in the middle ROM without intelligent stretching and active movement training without robotic guidance.

For both groups, the therapeutic training will be conducted during 5 hourly sessions (including breaks/transitions between tasks) each week over about 3-week hospital stay. Both groups will also receive the standard of care in the hospital and rehabilitation service. Treatment outcome measures will be obtained through blinded assessments and evaluated before and after training involving biomechanical, neuromuscular and clinical outcome measures. Carry-over effects will be further evaluated 1 month after the treatment ends.

Aim 1: To evaluate biomechanical and neuromuscular changes as defined by the passive and active range of motion (ROM), flexor-extensor muscle strength, joint stiffness, proprioception and reflex excitability, and compare these measures between the two groups. The biomechanical and neuromuscular outcome measures will be obtained through blinded assessments and evaluated before and after training using the wearable rehabilitation robot.

Hypothesis 1: Robot-guided motor relearning, stretching and active movement training (Study group) will improve the biomechanical and neuromuscular outcome measures more than those of the Control group.

Aim 2: To evaluate the clinical outcome measures as defined by Fugl-Meyer score (lower extremity), modified Ashworth scale, Berg balance scale, 10 meter walk test, and to compare between the Study and Control groups.

Hypothesis 2: The Study group will improve the clinical outcome measures more than the Control group.

Interventions

• Device stretching and active movement training
  A portable rehabilitation robot will be used to strongly or gently move the impaired ankle joint back and forth. Then subjects will be asked to use muscles to move the ankle with or without the robotic guidance depending on which group the subjects are in.

Primary outcome measures

• Changes of Fugl-Meyer Lower Extremity (FMLE) [Time frame: At the beginning and end of 3-week training, and 1 month after the treatment ends]

Secondary outcome measures (7)

• Changes of active range of motion (AROM) [Time frame: At the beginning and end of 3-week training, and 1 month after the treatment ends]
• Changes of passive range of motion (PROM) [Time frame: At the beginning and end of 3-week training, and 1 month after the treatment ends]
• Changes of ankle strength [Time frame: At the beginning and end of 3-week training, and 1 month after the treatment ends]
• Changes of ankle stiffness [Time frame: At the beginning and end of 3-week training, and 1 month after the treatment ends]
• Changes of Modified Ashworth Scale (MAS) [Time frame: At the beginning and end of 3-week training, and 1 month after the treatment ends]
• Changes of Berg Balance Scale [Time frame: At the beginning and end of 3-week training, and 1 month after the treatment ends]
• Changes of 10 meter Walk Test [Time frame: At the beginning and end of 3-week training, and 1 month after the treatment ends]

Eligibility criteria

Inclusion criteria

• First time unilateral acute stroke, hemorrhagic or ischemic, 24 hours after admission in hospital to 1 year post stroke.
• Hemiplegia or hemiparesis
• Age 18-80
• Ankle impairments

Exclusion criteria

• No impairment or very mild ankle impairment of ankle.
• Unstable medical conditions that interferes with ability to training and exercise.
• Severe cardiovascular disorders that interfere with ability to perform moderate movement exercises.
• Cognitive impairment or aphasia with inability to follow instructions
• Pressure ulcer, recent surgical incision or active skin disease with open wounds present below knee of treated limb
• Severe pain in legs

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, Baltimore — Baltimore

Publications

• Albert SJ, Kesselring J. Neurorehabilitation of stroke. J Neurol. 2012 May;259(5):817-32. doi: 10.1007/s00415-011-6247-y. Epub 2011 Oct 1. PMID 21964750
• Bernhardt J, Chan J, Nicola I, Collier JM. Little therapy, little physical activity: rehabilitation within the first 14 days of organized stroke unit care. J Rehabil Med. 2007 Jan;39(1):43-8. doi: 10.2340/16501977-0013. PMID 17225037
• Bernhardt J, Dewey H, Thrift A, Donnan G. Inactive and alone: physical activity within the first 14 days of acute stroke unit care. Stroke. 2004 Apr;35(4):1005-9. doi: 10.1161/01.STR.0000120727.40792.40. Epub 2004 Feb 26. PMID 14988574
• Chung SG, van Rey E, Bai Z, Rymer WZ, Roth EJ, Zhang LQ. Separate quantification of reflex and nonreflex components of spastic hypertonia in chronic hemiparesis. Arch Phys Med Rehabil. 2008 Apr;89(4):700-10. doi: 10.1016/j.apmr.2007.09.051. PMID 18374001
• Chung SG, Van Rey E, Bai Z, Roth EJ, Zhang LQ. Biomechanic changes in passive properties of hemiplegic ankles with spastic hypertonia. Arch Phys Med Rehabil. 2004 Oct;85(10):1638-46. doi: 10.1016/j.apmr.2003.11.041. PMID 15468024
• Chen K, Wu YN, Ren Y, Liu L, Gaebler-Spira D, Tankard K, Lee J, Song W, Wang M, Zhang LQ. Home-Based Versus Laboratory-Based Robotic Ankle Training for Children With Cerebral Palsy: A Pilot Randomized Comparative Trial. Arch Phys Med Rehabil. 2016 Aug;97(8):1237-43. doi: 10.1016/j.apmr.2016.01.029. Epub 2016 Feb 20. PMID 26903143
• Quality Standards Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society; Delgado MR, Hirtz D, Aisen M, Ashwal S, Fehlings DL, McLaughlin J, Morrison LA, Shrader MW, Tilton A, Vargus-Adams J. Practice parameter: pharmacologic treatment of spasticity in children and adolescents with cerebral palsy (an evidence-based review): report of the Quality PMID 20101040
• Gao F, Grant TH, Roth EJ, Zhang LQ. Changes in passive mechanical properties of the gastrocnemius muscle at the muscle fascicle and joint levels in stroke survivors. Arch Phys Med Rehabil. 2009 May;90(5):819-26. doi: 10.1016/j.apmr.2008.11.004. PMID 19406302

Identifiers

NCT: NCT02369770 · HP-00080466

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗