Clinical Studies

For a full copy of any of the below clinical articles, please contact us at 800-845-1771 or email info@neuromove.com with your complete address to receive a printed copy of these clinical articles in their entirety.

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Several independent clinical studies have been published in peer-reviewed journals, such as "Arch Phys Med Rehabil" and "Stroke". Below you will find a number of these in summary and in photocopy. The studies show effectiveness of the technique compared to control groups using regular therapy, electrical stimulation or no treatment. Most of the studies included patients between 6 months and 14 years post-stroke, subjects were motivated and cognitively intact, and the findings were:

* The time since the stroke did not impact effectiveness.

* Results were independent of age, side and nature of stroke.

* Improvements were maintained long-term.

* Improvements were in form of improved strength, range-of-motion, reduced spasticity and tone, flexibility, and motor capability in general. Regular therapy and electrical stimulation was less than half as effective.

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Electrical stimulation driving functional improvements and cortical changes in subjects with stroke

Teresa J. Kimberley, Scott M. Lewis, Edward J. Auerbach, Lisa L. Dorsey, Jeanne M. Lojovich and James R. Carey, University of Minnesota

Published November 15, 2003, in "Experimental Brain Research".

Summary: It has been proposed that somatosensory stimulation in the form of electromyographically triggered neuromuscular electrical stimulation (NMES) to the peripheral nerve can influence functional measures of motor performance in subjects with stroke and can additionally produce changes in cortical excitability. Using a controlled, double-blind design, we studied the effects of intensive (60 h/3 weeks) treatment at home with NMES compared with a sham treatment, applied to the extensor muscles of the hemiplegic forearm to facilitate hand opening in 16 chronic stroke subjects. We investigated improvement in functional use of the hand and change in cortical activation as measured by functional magnetic resonance imaging (fMRI). Following treatment, subjects improved on measures of grasp and release of objects (Box and Block Test and Jebsen Taylor Hand Function Test [JTHFT]: small objects, stacking, heavy cans), isometric finger extension strength, and self-rated Motor Activity Log (MAL): Amount of Use and How Well score. The sham subjects did not improve on any grasp and release measure or self-rated scale, but did improve on isometric finger extension strength. Importantly, however, following crossover, these subjects improved further in the measure of strength, grasp and release (Box and Block [JTHFT]: page turning), and self-rated MAL: Amount of Use score and How Well score. Using fMRI and a finger-tracking task, an index of cortical intensity in the ipsilateral somatosensory cortex increased significantly from pre-test to post-test following treatment. Cortical activation, as measured by voxel count, did not change. These findings suggest that NMES may have an important role in stimulating cortical sensory areas allowing for improved motor function.

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Techniques to Improve Function of the Arm and Hand in Chronic Hemiplegia
-George H. Kraft, MD, Sally S. Fitts, Ph.D., Margaret C. Hammond, MD. Arch Phys Med Rehabil Vol 73, March 1992.

Summary:

We evaluated functional improvement in the upper limb of chronic (more than six months' duration) stroke patients who received one of two electrical stimulation treatments, conventional treatment, or no treatment. Twenty-two right-handed patients were assigned to one of four groups studied for 12 months posttreatment. Subjects received (1) EMG-initiated electrical stimulation of wrist extensors (EMG-stim), (2) low-intensity electrical stimulation of wrist extensors combined with voluntary contractions (B/B), (3) proprioceptive neuromuscular facilitation (PNF) exercises, or (4) no treatment. Subjects were treated for three months. Before treatment, upon completion of treatment, and three and nine months after treatment, subjects were evaluated by th Fugl-Meyer (FM) poststroke motor recovery test and by grip strength. Subjects also attempted three Jebsen-Taylor hand function tests and a finger tapping test at the same evaluation sessions, but many were unable to complete these tests. During the course of treatment, FM scores of subjects receiving PNF improved 18%, B/B improved 25%, and EMG-stim improved 42%. The aggregate FM improvement of the treated groups was significant from pretreatment to posttreatment, and the improvement was maintained at three-months and nine-months follow-ups (all p<.005).the treated subjects' improvement in grip strength was also maintained at both follow-ups (p, .10). In contrast, the control group showed no significant change in FM scores or grip strength. The four treated subjects who were able to perform the hand function tests and finger tapping at all four evaluations also improved on these tests. 

We conclude that chronic stroke patients can achieve and maintain functional improvements, especially by combining electrical stimulation techniques with voluntary effort.


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Chronic Motor Dysfunction After Stroke.
James Cauraugh, PhD; Kathye Light, PhD, PT; Sangbum Kim, MS; Mary Thigpen, PT, MHS; Andrea Behrman, PhD, PT. 2000

Summary:

Recovering Wrist and Finger Extension by Electromyography-Triggered Neuromuscular Stimulation.

Background and Purpose - After stroke, many individuals have chronic unilateral motor dysfunction in the upper extremity that severely limits their functional movement control. The purpose of this study was to determine the effect of electromyography-triggered neuromuscular electrical stimulation on the wrist and finger extension muscles in individuals who had a stroke >1 year earlier.

Methods - Eleven individuals volunteered to participate and were randomly assigned to either the electromyography-triggered neuromuscular stimulation experimental group (7subjects) or the control group (4 subjects). After completing a pretest involving 5 motor capability tests, the poststroke subjects completed 12 treatment sessions (30 minutes each) according to group assignments. Once the control subjects completed 12 sessions attempting wrist and finger extension without any external assistance and were posttested, they were then given 12 sessions of the rehabilitation treatment.

Results - The Box and Block test and the force-generation task (sustained muscular contraction) revealed significant findings (P<0.05). The experimental group moved significantly more blocks and displayed a higher isometric force impulse after the rehabilitation treatment.

Conclusions - Two lines of evidence clearly support the use of the electromyography-triggered neuromuscular electrical stimulation treatment to rehabilitate wrist and finger extension movements of hemiparetic individuals > year after stroke. The treatment program decreased motor dysfunction and improved the motor capabilities in this group of poststroke individuals.

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Electromyogram-Triggered Neuromuscular Stimulation for Improving the Arm Function of Acute stroke Survivors: A Randomized Pilot Study
-Gerard Francisco, MD, Jon Chae, MD, ME, Harmeen Chawla, MD, Steven Kirshblum, MD, Richard Zorowitz, MD, Gerald Lewis, MS, PT, Shcone Pang, MS, OTR. Arch. Phys. Med. Rehabil 1998; 79:570-575

Summary:

Objective: To assess the efficacy of electromyogram (EMG)-triggered neuromuscular stimulation (EMG-stim) in enhancing upper extremity motor and functional recovery of acute stroke survivors.
Design: A pilot randomized, single-blinded clinical trial.
Setting: Freestanding inpatient rehabilitation facility.
Patients: Nine subjects who were within 6 weeks of their first unifocal. nonhemorrhagic stroke were randomly assigned to either the EMG-stim (n=4) or control (n=5) group. All subjects had a detectable EMG signal (>5?V) from the surface of the paretic extensor carpi radialis and voluntary wrist of the paretic extensor carpi radialis and voluntary wrist extension in synergy or in isolation with muscle grade of <3/5.
Intervention: All subjects received two 30-minute sessions per say of wrist strengthening exercises with EMG-stim (experimental) or without (control) for the duration of their rehabilitation stay.
Main Outcome Measures: Upper extremity Fugl-Meyer motor assessment and the feeding, grooming, and upper body dressing items of the Functional Independence Measure (FIM) were assessed at study entry and at discharge.
Results: Subjects treated with EMG-stim exhibited significantly greater gains in Fugl-Meyer (27.0 vs 10.4; p=.05), and FIM (6.0 vs 3.4: p=.02) scores compared with controls.

Conclusion: Data suggest that EMG-stim enhances the arm function of acute stroke survivors


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Electromyographically triggered electric muscle stimulation for chronic hemiplegia.

-R.W. Fields, Arch. Phys. Med. Rehabil 1987 Jul;68(7):407-14.

Electromyographically triggered electric muscle stimulation (EMS) was evaluated in combination with conventional treatment in 69 consecutive postcerebrovascular accident outpatients whose onset of hemiplegia was four months to 14 years earlier. Six subjects initially exhibited no residual volitional activity in targeted muscles, and all patients had undergone conventional therapy with little or no functional recovery. Prescribed treatment (patient compliance was frequently substandard) involved several months of four to five sessions per week, focusing on wrist extension and/or ankle dorsiflexion initially, and often other movements later. During 30 to 300 movement attempts per session, EMG's that exceeded a preset threshold triggered immediate stimulation to force movement completion. Over sessions, patients commonly realized substantially improved increases in voluntary EMG capabilities generally proportionate to the frequency of treatment sessions. Parallel improvements were also found for subjectively scaled functional measures of range-of-motion and ambulation. Motivation was important to success, but side and nature of stroke, age, and poststroke interval were not. Progress often far exceeded that of previous conventional therapy. Regarding mechanisms, impaired proprioceptive feedback is considered central to stroke-disrupted sensorimotor control. EMG-triggered EMS is intended to improve brain relearning by reinstating proprioceptive feedback time-locked to each attempted movement. Clinical results were consistent with this theory.

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Mental Practice of Motor Skills used in poststroke Rehabilitation has Own Effects on Central Nervous Activation.
-T. Weiss, Ellen Hansen, R. Rost, L. Beyer, F. Merten, Christa Nichelmann, and C. Zippel. Intern J. Neuroscience, 1994, Vol. 78, pp 1 57-166.

Summary:

In the last years it has been shown that the use of the EMG triggered electrical myostimulation (ETEM) brings good results in poststroke rehabilitation. It has been hypothesized that the relearning effects obtained by means of ETEM are due to the reinstatement of proprioceptive feedback. However, the technique is most powerful if imagination of motor acts (the so called mental practice) is used as an initial part of ETEM. Since mental practice in healthy people leads to central nervous activation processes as well as to an improvement of motor skills, we investigated the effects of mental practice alone on central nervous activity by means of EEG in stroke patients.
Twelve left-sided hemiplegic patients who underwent a specific poststroke rehabilitation treatment were requested to perform a simple arm movement sequence. In the following mental practice period the patients were requested to imagine the same sequence without any real movement. EEG background activity was recorded during baseline and imagination periods. After the calculation of z-transformed power values within the alpha and beta-1 band, differences between rest and imagination periods were evaluated for significance.
Stroke patients showed significant decreases of alpha as well as beta-1 power during mental practice in comparison to the rest period. These changes are similar to those obtained in healthy subjects. Central alpha power diminished only during imagination of the contralateral arm. This phenomenon as well as the decrease of beta-1 power in central derivation were also obtained during real motor performance and might indicate an activation of the sensorimotor cortex. In accordance with the hypothesis of internal feedback mechanisms, this activation is a necessary prerequisite for motor learning during mental practice.

 We conclude that mental practice of motor skills might have own effects in poststroke rehabilitation.

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Treatment of Hemiplegia by Means of Imagination-dependent EMG-triggered muscle stimulation.

-J. Danz, S. Gutierrez-Lopez. Physikalische Medizin, Heft 1, 4. Jahrgang, Feb. 1994.

Summary:

The imagination of a movement elevates the electrical activity of paralyzed muscles. By means of a device Automove, this changed activity is used to generate low-frequency pulses which in turn are applied to induce a contraction of the spastic antagonist muscles. In this way the imagination-dependent muscle stimulation - triggered by EMG - circumvents the spastic movement patterns. The patient becomes able to regain forgotten movements by means of the method described.
During the acute phase after a stroke it was applicable in only one third of our patients (n=40). Another group consisted of out-patients (n=20). In 18 of these a functional improvement of the paralyzed arm was attained after treatment for six months.


For a full copy of any of the below clinical articles, please contact us at 800-845-1771 or email info@neuromove.com with your complete address to receive a printed copy of these clinical articles in their entirety.

 

Two Coupled Motor Recovery Protocols Are Better Than One
Electromyogram-Triggered Neuromusular Stimulation and Bilateral Movements

(Stroke. 2002;33:1589-1594)

James H. Cauraugh, PhD; Sangbum Kim, MS

Background and Purpose-Overcoming chronic hemiparesis from a cerebrovascular accident (CVA) can be challenging for many patiens, especially after the first 12 months after the CVA. With the use of established motor control theories, the present study investigated electromyogram (EMG)-triggered neuromuscular stimulation and bilateral coordination training.

Methods-Twenty-five CVA subjects volunteered to participate in this motor recovery protocol study. Subjects were randomly assigned to 1 of 3 groups: (1) coupled protocol of EMG-triggered stimulation and bilateral movement (n=10); (2) EMG-triggered stimulation and unilateral movement (n=10); or (3) control (n=5). all participants completed 6 hours of rehabilitation during a 2-week period according to group assignments. Motor capabilities of the wrist and fingers were evaluated on the basis of 3 categories of motor tasks in a pretest-posttest control group design.

Results-Significant findings for the (1) number of blocks moved in a functional task, (2) chronometric reaction times to initiate movements, and (3) sustained muscle contraction capability all favored the coupled bilateral movement training and EMG-triggered neuromuscular stimulation protocol group. In addition, the unilateral movement/stimulation group exceeded the control group in the number of blocks moved and rapid onset of muscle contractions.

Conclusions-This new evidence is convincing in that subjects in the coupled protocol group were able to demonstrate enhanced voluntary motor control across 3 categories of tasks. Chronic hemiparesis decreased considerably in the wrist and fingers as CVA patients expanded their motor repertoire. 




























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