37 research outputs found
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A standardized approach to performing the action research arm test.
The study of stroke and its treatment in human subjects requires accurate measurement of behavioral status. Arm motor deficits are among the most common sequelae after stroke. The Action Research Arm Test (ARAT) is a reliable, valid measure of arm motor status after stroke. This test has established value for characterizing clinical state and for measuring spontaneous and therapy-induced recovery; however, sufficient details have not been previously published to allow for performance of this scale in a standardized manner over time and across sites. Such an approach to ARAT scoring would likely reduce variance between investigators and sites. This report therefore includes a manual that provides a highly detailed and standardized approach for assigning ARAT scores. Intrarater reliability and interrater reliability, as well as validity, with this approach were measured and are excellent. The ARAT, when performed in a standardized manner, is a useful tool for assessment of arm motor deficits after stroke
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A tele-assessment system for monitoring treatment effects in subjects with spinal cord injury.
We developed a method for remote measurement of balance and leg force in patients with spinal cord injury (SCI). In a group of 21 patients, both telemedicine and conventional clinical assessments were conducted at baseline and six months later. Telemedicine assessments were successfully acquired and transmitted at first attempt. The time required to set up the telemedicine equipment, position the subject, perform the measurements, and then send the data to the university laboratory was approximately 30 minutes. After six months, several motor and sensory functions showed significant changes. There were significant correlations between changes in remotely-measured leg force and changes in several of the American Spinal Injury Association (ASIA) sensory and motor scores. Changes in balance did not show any significant correlations with changes in the ASIA scores. Intra-rater reliability was better than inter-rater reliability. Use of telemedicine to remotely monitor changes in patients with SCI appears promising
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Safety and behavioral effects of a single session of high frequency repetitive transcranial magnetic stimulation in chronic stroke
Multi-center, single-blind randomized controlled trial comparing functional electrical stimulation therapy to conventional therapy in incomplete tetraplegia
BackgroundLoss of upper extremity function after tetraplegia results in significant disability. Emerging evidence from pilot studies suggests that functional electrical stimulation (FES) therapy may enhance recovery of upper extremity function after tetraplegia. The aim of this trial was to determine the effectiveness of FES therapy delivered by the Myndmove stimulator in people with tetraplegia.MethodsA multi-center, single-blind, parallel-group, two-arm, randomized controlled trial was conducted comparing FES to conventional therapy in adults (≥18 years) with C4–C7 traumatic incomplete tetraplegia between 4 and 96 months post-injury, and with a baseline spinal cord injury independence measure III -self-care (SCIM III-SC) score of ≤10. Participants were enrolled at four SCI-specialized neurorehabilitation centers in the U.S. and Canada. Participants were stratified by center and randomized in a 1:1 ratio to receive either 40 sessions of FES or conventional therapy targeting upper extremities over a 14-week period. Blinded assessors measured SCIM III, Toronto Rehabilitation Institute Hand Function Test, and Graded Redefined Assessment of Strength, Sensibility, and Prehension at baseline, after 20th session, after 40th session or 14 weeks after 1st session, and at 24 weeks after 1st session. The primary outcome measure was change in SCIM III-SC from baseline to end of the treatment. Based on the primary outcome measure, a sample size of 60 was calculated. Seventeen participants' progress in the study was interrupted due to the COVID-19 lockdown. The protocol was modified for these participants to allow them to complete the study.ResultsBetween June 2019 to August 2021, 51 participants were randomized to FES (n = 27) and conventional therapy (n = 24). Both groups gained a mean of 2 points in SCIM-SC scores at the end of treatment, which was a clinically meaningful change. However, there was no statistically significant difference between the groups on any outcomes.ConclusionForty sessions of FES therapy delivered by the MyndMove stimulator are as effective as conventional therapy in producing meaningful functional improvements that persist after therapy is completed. Limitations of this study include the impact of COVID-19 limiting the ability to recruit the target sample size and per-protocol execution of the study in one-third of the participants.RegistrationThis trial is registered at www.ClinicalTrials.gov, NCT03439319
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Vagus nerve stimulation paired with upper limb rehabilitation after chronic stroke
Background and Purpose:
We assessed safety, feasibility, and potential effects of vagus nerve stimulation (VNS) paired with rehabilitation for improving arm function after chronic stroke.
Methods:
We performed a randomized, multisite, double-blinded, sham-controlled pilot study. All participants were implanted with a VNS device and received 6-week in-clinic rehabilitation followed by a home exercise program. Randomization was to active VNS (n=8) or control VNS (n=9) paired with rehabilitation. Outcomes were assessed at days 1, 30, and 90 post-completion of in-clinic therapy.
Results:
All participants completed the course of therapy. There were 3 serious adverse events related to surgery. Average FMA-UE scores increased 7.6 with active VNS and 5.3 points with control at day 1 post–in-clinic therapy (difference, 2.3 points; CI, −1.8 to 6.4; P=0.20). At day 90, mean scores increased 9.5 points from baseline with active VNS, and the
control scores improved by 3.8 (difference, 5.7 points; CI, −1.4 to 11.5; P=0.055). The clinically meaningful response rate of FMA-UE at day 90 was 88% with active VNS and 33% with control VNS (P<0.05).
Conclusions:
VNS paired with rehabilitation was acceptably safe and feasible in participants with upper limb motor deficit after chronic ischemic stroke. A pivotal study of this therapy is justified