Sensory-Motor Rehabilitation for Stroke
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Maryland, Baltimore
Disqualifiers: Unstable conditions, Cardiovascular disorders, Cognitive impairment, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Stretching and Active Movement Training, Sensorimotor Rehabilitation, Motor-Sensory Rehabilitation for stroke patients?
Is sensory-motor rehabilitation safe for humans?
How is the Stretching and Active Movement Training treatment for stroke different from other treatments?
Stretching and Active Movement Training is unique because it combines both sensory and motor rehabilitation, focusing on retraining sensory function, which is often overlooked in stroke recovery. This approach aims to improve both sensation and motor function, potentially enhancing overall recovery compared to treatments that focus solely on motor rehabilitation.12389
Eligibility Criteria
This trial is for stroke survivors aged 18-80 with ankle impairments and hemiplegia or hemiparesis. It's suitable for those who've had their first unilateral acute stroke, either hemorrhagic or ischemic, from 24 hours to a year post-stroke. Excluded are individuals with mild/no impairment, severe cardiovascular issues, cognitive impairments preventing instruction following, unstable medical conditions, leg ulcers/wounds below the knee, or severe leg pain.Inclusion Criteria
I am between 18 and 80 years old.
I have issues with my ankle.
I have weakness or paralysis on one side of my body.
See 1 more
Exclusion Criteria
You have a medical condition that makes it hard for you to train and exercise regularly.
I experience severe leg pain.
I have an open wound or recent surgery below the knee of the limb being treated.
See 3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants receive intensive motor-sensory rehabilitation using a wearable rehabilitation robot for 3 weeks
3 weeks
5 sessions per week
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
1 visit (in-person)
Treatment Details
Interventions
- Stretching and Active Movement Training (Robotics)
Trial OverviewThe study tests an intensive motor-sensory rehabilitation using a wearable robot on patients after a stroke. The goal is to aid sensorimotor recovery and improve balance and walking by reducing ankle impairments. Participants will be randomly assigned to either the Study group receiving therapy or Control group.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Study groupExperimental Treatment1 Intervention
Subjects in the Study group will receive stretching and active movement training with robotic guidance and intelligent control
Group II: Control groupExperimental Treatment1 Intervention
Subjects in the Control group will receive stretching and active movement training without robotic guidance.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Maryland, BaltimoreBaltimore, MD
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Who Is Running the Clinical Trial?
University of Maryland, BaltimoreLead Sponsor
Northwestern UniversityCollaborator
Northwestern Memorial HospitalCollaborator
References
Does Sensory Retraining Improve Sensation and Sensorimotor Function Following Stroke: A Systematic Review and Meta-Analysis. [2020]Background: Reduced sensation is experienced by one in two individuals following stroke, impacting both the ability to function independently and overall quality of life. Repetitive activation of sensory input using active and passive sensory-based interventions have been shown to enhance adaptive motor cortical plasticity, indicating a potential mechanism which may mediate recovery. However, rehabilitation specifically focusing on somatosensory function receives little attention. Objectives: To investigate sensory-based interventions reported in the literature and determine the effectiveness to improve sensation and sensorimotor function of individuals following stroke. Methods: Electronic databases and trial registries were searched from inception until November 2018, in addition to hand searching systematic reviews. Study selection included randomized controlled trials for adults of any stroke type with an upper and/or lower limb sensorimotor impairment. Participants all received a sensory-based intervention designed to improve activity levels or impairment, which could be compared with usual care, sham, or another intervention. The primary outcomes were change in activity levels related to sensorimotor function. Secondary outcomes were measures of impairment, participation or quality of life. Results: A total of 38 study trials were included (n = 1,093 participants); 29 explored passive sensory training (somatosensory; peripheral nerve; afferent; thermal; sensory amplitude electrical stimulation), 6 active (sensory discrimination; perceptual learning; sensory retraining) and 3 hybrid (haptic-based augmented reality; sensory-based feedback devices). Meta-analyses (13 comparisons; 385 participants) demonstrated a moderate effect in favor of passive sensory training on improving a range of upper and lower limb activity measures following stroke. Narrative syntheses were completed for studies unable to be pooled due to heterogeneity of measures or insufficient data, evidence for active sensory training is limited however does show promise in improving sensorimotor function following stroke. Conclusions: Findings from the meta-analyses and single studies highlight some support for the effectiveness of passive sensory training in relation to sensory impairment and motor function. However, evidence for active sensory training continues to be limited. Further high-quality research with rigorous methods (adequately powered with consistent outcome measures) is required to determine the effectiveness of sensory retraining in stroke rehabilitation, particularly for active sensory training.
Evidence for the retraining of sensation after stroke: a systematic review. [2022]Retraining of sensory function following stroke is frequently overlooked in rehabilitation protocols despite more than 60% of patients presenting with sensory deficits. Methods to train sensory function include both passive and active training protocols. Here we examined the volume and quality of the evidence available for both passive and active sensory training following stroke. In addition, we aimed to quantify the effect of sensory training on impairment and function.
Active Sensory Therapies Enhancing Upper Limb Recovery Among Poststroke Subjects: A Systematic Review. [2022]In stroke, sensory deficits may affect the motor recovery of the subjects. The evidence for the active sensory intervention to enhance motor recovery is sparsely available.
Progress in sensorimotor rehabilitative physical therapy programs for stroke patients. [2022]Impaired motor and functional activity following stroke often has negative impacts on the patient, the family and society. The available rehabilitation programs for stroke patients are reviewed. Conventional rehabilitation strategies (Bobath, Brunnstrom, proprioception neuromuscular facilitation, motor relearning and function-based principles) are the mainstream tactics in clinical practices. Numerous advanced strategies for sensory-motor functional enhancement, including electrical stimulation, electromyographic biofeedback, constraint-induced movement therapy, robotics-aided systems, virtual reality, intermittent compression, partial body weight supported treadmill training and thermal stimulation, are being developed and incorporated into conventional rehabilitation programs. The concept of combining valuable rehabilitative procedures into "a training package", based on the patient's functional status during different recovery phases after stroke is proposed. Integrated sensorimotor rehabilitation programs with appropriate temporal arrangements might provide great functional benefits for stroke patients.
How much exercise does the enhanced gait-oriented physiotherapy provide for chronic stroke patients? [2016]Physical exercise therapy in sensorimotor rehabilitation of stroke patients includes active and repetitive exercise and task-specific training. The time spent in active practice is fundamental. The purpose of this study was to analyse what was the actual amount of exercise and content of the performed exercise of the three-week gait-oriented physiotherapy program for chronic stroke patients in an in-patient setting.
Improved function of hemiplegic upper extremity after cognitive sensory motor training therapy in chronic stroke patients: preliminary report of a case series. [2007]Recovery of upper extremity functions after a severe stroke and traumatic brain injuries (TBI) have generally been less than satisfactory. The "cognitive sensory motor training therapy" is a relatively new method claimed to improve motor control using a specific type of repetitive sensory and motor re-learning protocol. There has been no previous study demonstrating the effectiveness of this method.
Effects of joint mobilization and stretching on the range of motion for ankle joint and spatiotemporal gait variables in stroke patients. [2020]Stroke patients have limited ranges of motion and gait disturbances due to neurological deficits and connective tissue changes. We assessed the effects of joint mobilization and active stretching on ankle joint range of motion and gait in stroke patients.
COMbined Physical and somatoSEnsory training after stroke: Development and description of a novel intervention to improve upper limb function. [2019]After stroke, reach-to-grasp goal-directed movements are disrupted as a result of both residual motor and somatosensory impairments. This report describes the rationale and development of a new upper limb stroke rehabilitation intervention known as COMPoSE: "COMbined Physical and somatoSEnsory training," designed to improve somatosensory and motor deficits in the upper limb after stroke. A standardized training matrix has been developed to facilitate intervention delivery.
Tactile Sensation Improves Following Motor Rehabilitation for Chronic Stroke: The VIGoROUS Randomized Controlled Trial. [2022]Background. Up to 85% of people with chronic stroke experience somatosensory impairment, which contributes to poor sensorimotor control and non-use of the affected limb. Neurophysiological mechanisms suggest motor rehabilitation may improve tactile sense post-stroke, however, somatosensory recovery has rarely been reported in controlled trials. Objective. To compare the effect of four upper limb motor rehabilitation programs on the recovery of tactile sensation in adults with chronic stroke. Methods. Adults with chronic stroke and mild or moderate upper extremity hemiparesis (n = 167) were enrolled in a multi-site randomized controlled trial. Participants completed three weeks of gaming therapy, gaming therapy with additional telerehabilition, Constraint-Induced Movement therapy, or traditional rehabilitation. Here, we report the results of a secondary outcome, tactile sensation, measured with monofilaments, before and after treatment, and 6 months later. Results. A mixed-effects general linear model revealed similar positive change in tactile sensitivity regardless of the type of training. On average, participants were able to detect a stimulus that was 32% and 33% less after training and at 6-month follow-up, respectively. One-third of participants experienced recategorization of their level of somatosensory impairment (e.g., regained protective sensation) following training. Poorer tactile sensation at baseline was associated with greater change. Conclusions. About one-third of individuals with mild/moderate chronic hemiparesis experience sustained improvements in tactile sensation following motor rehabilitation, regardless of the extent of tactile input in the rehabilitation program. Potential for sensory improvement is an additional motivator for those post-stroke. Characteristics of those who improve and mechanisms of improvement are important future questions. Clinicaltrials.gov NCT02631850.