Sensory Stimulation for Stroke Recovery
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Medical University of South Carolina
No Placebo Group
Trial Summary
What is the purpose of this trial?The objective of this study is to determine if combining vibration with hand task practice is superior to hand task practice alone.
Is the treatment Concomitant Sensory Stimulation (TheraBracelet) a promising treatment for stroke recovery?Yes, Concomitant Sensory Stimulation using TheraBracelet is promising for stroke recovery. It can be used during hand tasks without interfering, potentially improving therapy outcomes. Studies show it is safe for daily use and may enhance hand function when combined with therapy.23456
What safety data exists for TheraBracelet in stroke recovery?A Phase I safety trial evaluated the TheraBracelet, a wrist-worn device providing low-level vibration, in stroke survivors. Participants wore the device for over 8 hours daily for two months. Adverse events were monitored weekly, focusing on hand sensation, dexterity, grip strength, pain, spasticity, and skin irritation. Six out of 25 participants experienced mild adverse events, with fewer events occurring during the real stimulation month compared to the sham month. The study concluded that daily use of TheraBracelet is safe for chronic stroke survivors.34689
What data supports the idea that Sensory Stimulation for Stroke Recovery is an effective treatment?The available research shows that Sensory Stimulation for Stroke Recovery, such as using the TheraBracelet, is safe and may help improve recovery after a stroke. In a study where stroke survivors wore a wrist device that provided gentle vibrations, fewer participants experienced negative effects during the real stimulation period compared to a fake one. This suggests that the treatment is safe and could be beneficial. Additionally, other studies indicate that sensory interventions can improve both sensory and motor functions in stroke survivors, which supports the idea that this treatment can be effective.12457
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you've changed your spasticity medication or had an upper limb botulinum toxin injection within 3 months prior to or during enrollment.
Eligibility Criteria
This trial is for adults over 18 who had a stroke at least 6 months ago and have difficulty with hand tasks. They must be able to follow instructions and not be on certain spasticity medications or undergoing other upper limb therapies. Severe spasticity, skin issues at the wrist, or other conditions affecting arm function disqualify them.Inclusion Criteria
I can complete hand tasks quickly, in less than 120 seconds.
I am 18 years old or older.
Exclusion Criteria
I am currently receiving therapy for my arm.
My severe muscle stiffness hinders my ability to participate in physical therapy.
Participant Groups
The study is testing if adding vibration to regular hand exercises helps improve hand function better than just doing the exercises alone after a stroke. Participants will either receive real vibration stimulation or no stimulation while practicing hand tasks.
2Treatment groups
Active Control
Placebo Group
Group I: VibrationActive Control1 Intervention
The device will deliver imperceptible vibration for the treatment group.
Group II: No VibrationPlacebo Group1 Intervention
The device will deliver no vibration for the control group.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Medical University of South CarolinaCharleston, SC
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Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Collaborator
References
Sensory syndromes. [2012]Somatosensory deficit syndromes represent a common impairment following stroke and have a prevalence rate of around 80% in stroke survivors. These deficits restrict the ability of survivors to explore and manipulate their environment and are generally associated with a negative impact on quality of life and personal safety. Sensory impairments affect different sensory modalities in diverse locations at varying degrees, ranging from complete hemianesthesia of multiple modalities to dissociated impairment of somatosensory submodalities within a particular region of the body. Sensory impairments induce typical syndromal patterns which can be differentiated by means of a careful neurological examination, allowing the investigator to deduce location and size of the underlying stroke. In particular, a stroke located in the brainstem, thalamus, and the corticoparietal cortex result in well-differentiable sensory syndromes. Sensory function following stroke can be regained during rehabilitation even without specific sensory training. However, there is emerging evidence that specialized sensory interventions can result in improvement of somatosensory and motor function. Herein, we summarize the clinical presentations, examination, differential diagnoses, and therapy of sensory syndromes in stroke.
Sensory stimulation in acute stroke therapy. [2023]The beneficial effects of cortical activation for functional recovery after ischemic stroke have been well described. However, little is known about the role of early sensory stimulation, i.e. stimulation during first 6 h after stroke onset even during acute treatment. In recent years, various preclinical studies reported significant effects of acute sensory stimulation that range from entire neuroprotection to increased infarct volumes by 30-50%. Systematic knowledge about the effect of acute sensory stimulation on stroke outcome is highly relevant as stroke patients are subject to uncontrolled sensory stimulation during transport, acute treatment, and critical care. This article discusses the current stage of knowledge about acute sensory stimulation and provides directions for future experimental and clinical trials.
TheraBracelet Stimulation During Task-Practice Therapy to Improve Upper Extremity Function After Stroke: A Pilot Randomized Controlled Study. [2023]Peripheral sensory stimulation has been used in conjunction with upper extremity movement therapy to increase therapy-induced motor gains in patients with stroke. The limitation is that existing sensory stimulation methods typically interfere with natural hand tasks and thus are administered prior to therapy, requiring patients' time commitment. To address this limitation, we developed TheraBracelet. This novel stimulation method provides subthreshold (ie, imperceptible) vibratory stimulation to the wrist and can be used during hand tasks/therapy without interfering with natural hand tasks.
Phase I Safety Trial: Extended Daily Peripheral Sensory Stimulation Using a Wrist-Worn Vibrator in Stroke Survivors. [2021]Peripheral sensory stimulation augments post-stroke upper extremity rehabilitation outcomes. Most sensory stimulations interfere with natural hand tasks and the stimulation duration is limited. We developed TheraBracelet, low-level random-frequency vibration applied via a wristwatch, to enable stimulation during hand tasks and potentially extend stimulation durations. To determine safety of prolonged exposure to TheraBracelet. Single-site double-blind crossover randomized controlled trial. Chronic stroke survivors were instructed to wear a device on the affected wrist for > 8 h/day everyday for 2 months while coming to the laboratory weekly for evaluations, with a 2-week break between each month. The device applied vibration at 60% and 1% of the sensory threshold for the real and sham month, respectively. The order of the real and sham months was randomized/balanced. Adverse events (AEs) were assessed weekly, including worsening of hand sensation, dexterity, grip strength, pain, or spasticity and occurrence of skin irritation or swelling. Device-related AE rates were compared between the real and sham month. Twenty-five participants completed the study. Six participants (24%) experienced mild AEs involving worsened sensory scores that may be related to the intervention with reasonable possibility. Two experienced them in the real stimulation month only, 3 in the sham month only, and 1 in both months. Therefore, less participants experienced device-related AEs in the real than sham month. Daily stimulation using the device for a month is safe for chronic stroke survivors. Future studies examining the efficacy of pairing TheraBracelet with therapy for increasing neurorehabilitation outcomes are a logical next step. Trial registration: NCT03318341.
Transcutaneous Auricular Vagus Nerve Stimulation with Upper Limb Repetitive Task Practice May Improve Sensory Recovery in Chronic Stroke. [2020]Sensory impairment is associated with reduced functional recovery in stroke survivors. Invasive vagus nerve stimulation (VNS) paired with rehabilitative interventions improves motor recovery in chronic stroke. Noninvasive approaches, for example, transcutaneous auricular VNS (taVNS) are safe, well-tolerated and may also improve motor function in those with residual weakness. We report the impact of taVNS paired with a motor intervention, repetitive task practice, on sensory recovery in a cohort of patients with chronic stroke.
Concomitant sensory stimulation during therapy to enhance hand functional recovery post stroke. [2022]Post-stroke hand impairment is prevalent and persistent even after a full course of rehabilitation. Hand diminishes stroke survivors' abilities for activities of daily living and independence. One way to improve treatment efficacy is to augment therapy with peripheral sensory stimulation. Recently, a novel sensory stimulation, TheraBracelet, has been developed in which imperceptible vibration is applied during task practice through a wrist-worn device. The objective of this trial is to determine if combining TheraBracelet with hand task practice is superior to hand task practice alone.
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.
Effect of Using TheraBracelet on Grasping versus Reaching in Poststroke Rehabilitation. [2023]A peripheral sensory stimulation named TheraBracelet has recently been shown to have a potential to improve gross manual dexterity following stroke. Upper limb function requires both reach and grasp. It is unknown whether TheraBracelet affects one more than other. The objective of this study was to determine whether TheraBracelet improves reaching versus grasping. In a pilot randomized controlled trial, persons with stroke received TheraBracelet (treatment) or no stimulation (control) during task practice therapy (n = 6/group). Effects of TheraBracelet on reaching versus grasping were determined using breakdown of movement times in the Box and Block Test video recordings. Improvements in movement times for the treatment compared with control group were more pronounced for grasping than for reaching at both post and follow-up time points. TheraBracelet may be beneficial for persons with grasping deficits. This knowledge can guide clinicians for targeted use of TheraBracelet, resulting in effective implementation of the new treatment.
Effect of Self-Directed Home Therapy Adherence Combined with TheraBracelet on Poststroke Hand Recovery: A Pilot Study. [2023]Hand impairment is a common consequence of stroke, resulting in long-term disability and reduced quality of life. Recovery may be augmented through self-directed therapy activities at home, complemented by the use of rehabilitation devices such as peripheral sensory stimulation. The objective of this study was to determine the effect of adherence to self-directed therapy and the use of TheraBracelet (subsensory random-frequency vibratory stimulation) on hand function for stroke survivors. In a double-blind, randomized controlled pilot trial, 12 chronic stroke survivors were assigned to a treatment or control group (n = 6/group). All participants were instructed to perform 200 repetitions of therapeutic hand tasks 5 days/week while wearing a wrist-worn device 8 hours/day for 4 weeks. The treatment group received TheraBracelet vibration from the device, while the control group received no vibration. Home task repetition adherence and device wear logs, as well as hand function assessment (Stroke Impact Scale Hand domain), were obtained weekly. Repetition adherence was comparable between groups but varied among participants. Participants wore the device to a greater extent than adhering to completing repetitions. A linear mixed model analysis showed a significant interaction between repetition and group (p = 0.01), with greater adherence resulting in greater hand function change for the treatment group (r = 0.94; R 2 = 0.88), but not for the control group. Secondary analysis revealed that repetition adherence was greater for those with lower motor capacity and greater self-efficacy at baseline. This pilot study suggests that adherence to self-directed therapy at home combined with subsensory stimulation may affect recovery outcomes in stroke survivors. This trial is registered with NCT04026399.