Clinical trial NCT02675764: Sensory Stimulation to Enhance Hand Function Post Stroke
Official title: Sensory Stimulation to Enhance Hand Function Post Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: hand function
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2016-02-05
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this pilot project is to assess the impact of the novel sensory stimulation technique the investigators have developed in enhancing outcomes of hand therapy as well as the central nervous system responsiveness in chronic stroke survivors.

Detailed description: Stroke survivors suffer from persistent hand impairment that diminishes their functional abilities and independence, despite multiple courses of rehabilitation. Sensory stimulation can prime central excitability to increase therapy outcome. The investigators developed a new sensory stimulation technique for the hand, using imperceptible vibration applied to the wrist skin. Wearable devices with a vibrating function are low cost and can be easily adopted for rehabilitation purposes to impact a wide range of patients with sensorimotor impairment. Despite the potential for clinical benefits and easy adoption for high impact, knowledge about the long-term efficacy of this new sensory stimulation technique and its underlying mechanism is limited.

The objective of this pilot project is to assess the impact of the novel sensory stimulation technique the investigators have developed in enhancing outcomes of 2-week hand therapy as well as the central nervous system responsiveness in chronic stroke survivors. This impact will be assessed in a double-blind stratified randomized controlled trial. The hypothesis is that (a) improvement in hand function will be greater for the experimental group receiving the wrist subthreshold vibrotactile stimulation during therapy compared with the control group who will wear the device with no vibration (placebo). (b) Improvement in hand function is associated with neurophysiologic measures of central nervous system responsiveness. Clinical and neurophysiologic evaluations will be performed before, immediately after, and 2 weeks after a 2 week standardized hand therapy program with the subthreshold vibrotactile stimulation to the wrist vs. sham. The investigators preliminary studies demonstrated an acute effect of the remote subthreshold vibrotactile stimulation on immediately improved clinical sensory and motor function of the hand as well as cortical excitability in healthy young adults and chronic stroke survivors in single-session studies.

The expected outcome is the demonstration that the subthreshold vibrotactile stimulation at the wrist enhances hand function, not only immediately (preliminary studies) but also as a complement to therapy in chronic stroke survivors. This project will also provide preliminary insights regarding plasticity occurring with hand therapy augmented by the subthreshold vibrotactile stimulation. This research will have a positive impact by leading to a portable sensorimotor orthosis worn at the wrist to improve hand function for patients with sensorimotor deficits.

Eligibility criteria: Inclusion Criteria:

* mild to moderate impairment in upper extremity function

Exclusion Criteria:

* cognitive dysfunction
* stroke\<3 months
* treatment with botulinum toxin in the affected arm within 3 months of start of study

Primary outcomes:
measure: Box and Block Test (BBT) About a Week After the 2-week Intervention
timeFrame: post intervention (about a week after the 2-week therapy, or week 3) compared to baseline (before 2-week therapy)
measure: Box and Block Test (BBT) at Least 2 Weeks After the 2-week Intervention
timeFrame: follow up (at least 2 weeks after the 2-week therapy, or week 5) compared to baseline (before 2-week therapy)
measure: WMFT About a Week After the 2-week Intervention
timeFrame: post intervention (about a week after the 2-week therapy, or week 3) compared to baseline (before 2-week therapy)
measure: WMFT at Least 2 Weeks After the 2-week Intervention
timeFrame: follow up (2 weeks after the 2-week therapy, or week 5) compared to baseline (before 2-week therapy)
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Steven Kautz, PhD
role: STUDY_CHAIR
References:
citation: Seo NJ, Woodbury ML, Bonilha L, Ramakrishnan V, Kautz SA, Downey RJ, Dellenbach BHS, Lauer AW, Roark CM, Landers LE, Phillips SK, Vatinno AA. TheraBracelet Stimulation During Task-Practice Therapy to Improve Upper Extremity Function After Stroke: A Pilot Randomized Controlled Study. Phys Ther. 2019 Mar 1;99(3):319-328. doi: 10.1093/ptj/pzy143.