Sensory-Motor Rehabilitation Post Stroke

Acute Stroke Clinical Trial

Official title:

Sensory-Motor Rehabilitation Post Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02369770
• Other study ID #: HP-00080466
• Status: Recruiting
• Phase: N/A
• Start date: April 26, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: University of Maryland, Baltimore
• Contact: Michael Graziano, Ph.D.
• Phone: (410) 706-1584
• Email: Michael.Graziano[@]som.umaryland.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. First time unilateral acute stroke, hemorrhagic or ischemic, 24 hours after admission in hospital to 1 year post stroke.

2. Hemiplegia or hemiparesis

3. Age 18-80

4. Ankle impairments

Exclusion Criteria:

1. No impairment or very mild ankle impairment of ankle.

2. Unstable medical conditions that interferes with ability to training and exercise.

3. Severe cardiovascular disorders that interfere with ability to perform moderate movement exercises.

4. Cognitive impairment or aphasia with inability to follow instructions

5. Pressure ulcer, recent surgical incision or active skin disease with open wounds present below knee of treated limb

6. Severe pain in legs

Related Conditions & MeSH terms

• Acute Stroke
• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	University of Maryland, Baltimore	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

References & Publications (31)

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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

Sukal-Moulton T, Clancy T, Zhang LQ, Gaebler-Spira D. Clinical application of a robotic ankle training program for cerebral palsy compared to the research laboratory application: does it translate to practice? Arch Phys Med Rehabil. 2014 Aug;95(8):1433-40. doi: 10.1016/j.apmr.2014.04.010. Epub 2014 May 2. — View Citation

Waldman G, Yang CY, Ren Y, Liu L, Guo X, Harvey RL, Roth EJ, Zhang LQ. Effects of robot-guided passive stretching and active movement training of ankle and mobility impairments in stroke. NeuroRehabilitation. 2013;32(3):625-34. doi: 10.3233/NRE-130885. — View Citation

Wu YN, Hwang M, Ren Y, Gaebler-Spira D, Zhang LQ. Combined passive stretching and active movement rehabilitation of lower-limb impairments in children with cerebral palsy using a portable robot. Neurorehabil Neural Repair. 2011 May;25(4):378-85. doi: 10.1177/1545968310388666. Epub 2011 Feb 22. — View Citation

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Zhang LQ, Chung SG, Ren Y, Liu L, Roth EJ, Rymer WZ. Simultaneous characterizations of reflex and nonreflex dynamic and static changes in spastic hemiparesis. J Neurophysiol. 2013 Jul;110(2):418-30. doi: 10.1152/jn.00573.2012. Epub 2013 May 1. — View Citation

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Zhao H, Wu YN, Hwang M, Ren Y, Gao F, Gaebler-Spira D, Zhang LQ. Changes of calf muscle-tendon biomechanical properties induced by passive-stretching and active-movement training in children with cerebral palsy. J Appl Physiol (1985). 2011 Aug;111(2):435-42. doi: 10.1152/japplphysiol.01361.2010. Epub 2011 May 19. — View Citation

* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of Fugl-Meyer Lower Extremity (FMLE)	The assessment is a measure of lower extremity (LE) motor and sensory impairments.	At the beginning and end of 3-week training, and 1 month after the treatment ends
Secondary	Changes of active range of motion (AROM)	AROM will be measured in degrees in the ankle joint while subjects use the muscles to move the ankle.	At the beginning and end of 3-week training, and 1 month after the treatment ends
Secondary	Changes of passive range of motion (PROM)	PROM will be measured in degrees in the ankle joint while the robot moves the ankle of the subject strongly.	At the beginning and end of 3-week training, and 1 month after the treatment ends
Secondary	Changes of ankle strength	Strength of the ankle flexor-extensor muscle will be measured in Newton	At the beginning and end of 3-week training, and 1 month after the treatment ends
Secondary	Changes of ankle stiffness	Spasticity will be measured by the resistance torque in Newton-meter under controlled movement at each joint.	At the beginning and end of 3-week training, and 1 month after the treatment ends
Secondary	Changes of 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 ROM (range of movement); 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.	At the beginning and end of 3-week training, and 1 month after the treatment ends
Secondary	Changes of Berg Balance Scale	The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete.	At the beginning and end of 3-week training, and 1 month after the treatment ends
Secondary	Changes of 10 meter Walk Test	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.	At the beginning and end of 3-week training, and 1 month after the treatment ends