Electrical Somatosensory Stimulation Followed by Motor Training of the Paretic Upper Limb in Acute Stroke: Study Protocol for a Randomized Controlled Trial

Overview

Journal Trials

Publisher Biomed Central

Specialties General Medicine
Pharmacology

Date 2017 Feb 25

PMID 28231811

Citations 4

Authors

Emma Ghaziani

Christian Couppe

Cecilie Henkel

Volkert Siersma

Mette Sondergaard

Hanne Christensen

S Peter Magnusson

Affiliations

Soon will be listed here.

Abstract

Background: Upper limb paresis is one of the most frequent and persistent impairments following stroke. Only 12-34% of stroke patients achieve full recovery of upper limb functioning, which seems to be required to habitually use the affected arm in daily tasks. Although the recovery of upper limb functioning is most pronounced during the first 4 weeks post stroke, there are few studies investigating the effect of rehabilitation during this critical time window. The purpose of this trial is to determine the effect of electrical somatosensory stimulation (ESS) initiated in the acute stroke phase on the recovery of upper limb functioning in a nonselected sample of stroke patients.

Methods/design: A sample of 102 patients with upper limb paresis of varying degrees of severity is assigned to either the intervention or the control group using stratified random sampling. The intervention group receives ESS plus usual rehabilitation and the control group receives sham ESS plus usual rehabilitation. The intervention is applied as 1 h of ESS/sham ESS daily, followed by motor training of the affected upper limb. The ESS/sham ESS treatment is initiated within 7 days from stroke onset and it is delivered during hospitalization, but no longer than 4 weeks post stroke. The primary outcome is hand dexterity assessed by the Box and Block Test; secondary outcomes are the Fugl-Meyer Assessment, hand grip strength, pinch strength, perceptual threshold of touch, degree of pain, and modified Rankin Scale score. Outcome measurements are conducted at baseline, post intervention and at 6-month follow-up.

Discussion: Because of the wide inclusion criteria, we believe that the results can be generalized to the larger population of patients with a first-ever stroke who present with an upper limb paresis of varying severity. On the other hand, the sample size (n = 102) may preclude subgroup analyses in such a heterogeneous sample. The sham ESS treatment totals a mere 2% of the active ESS treatment delivered to the intervention group per ESS session, and we consider that this dose is too small to induce a treatment effect.

Trial Registration: ClinicalTrials.gov, NCT02250365 . Registered on 18 September 2014.

Citing Articles

Efficacy of contralaterally controlled functional electrical stimulation compared to cyclic neuromuscular electrical stimulation and task-oriented training for recovery of hand function after stroke: study protocol for a multi-site randomized....

Knutson J, Friedl A, Hansen K, Harley M, Barrett A, Raghavan P Trials. 2022; 23(1):397.

PMID: 35549747 PMC: 9097385. DOI: 10.1186/s13063-022-06303-y.

To stimulate or not to stimulate? A rapid systematic review of repetitive sensory stimulation for the upper-limb following stroke.

Stockley R, Hanna K, Connell L Arch Physiother. 2020; 10(1):20.

PMID: 33292869 PMC: 7708198. DOI: 10.1186/s40945-020-00091-x.

Motor relearning program along with electrical stimulation for improving upper limb function in stroke patients: A quasi experimental study.

Ullah I, Arsh A, Zahir A, Jan S Pak J Med Sci. 2020; 36(7):1613-1617.

PMID: 33235584 PMC: 7674909. DOI: 10.12669/pjms.36.7.2351.

Easily Conducted Tests During the First Week Post-stroke Can Aid the Prediction of Arm Functioning at 6 Months.

Ghaziani E, Couppe C, Siersma V, Christensen H, Magnusson S, Sunnerhagen K Front Neurol. 2020; 10:1371.

PMID: 31993016 PMC: 6962352. DOI: 10.3389/fneur.2019.01371.

References

Chan A, Tetzlaff J, Gotzsche P, Altman D, Mann H, Berlin J . SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013; 346:e7586. PMC: 3541470. DOI: 10.1136/bmj.e7586. View

Murray C, Barber R, Foreman K, Abbasoglu Ozgoren A, Abd-Allah F, Abera S . Global, regional, and national disability-adjusted life years (DALYs) for 306 diseases and injuries and healthy life expectancy (HALE) for 188 countries, 1990-2013: quantifying the epidemiological transition. Lancet. 2015; 386(10009):2145-91. PMC: 4673910. DOI: 10.1016/S0140-6736(15)61340-X. View

. Multicenter trial of hemodilution in ischemic stroke--background and study protocol. Scandinavian Stroke Study Group. Stroke. 1985; 16(5):885-90. DOI: 10.1161/01.str.16.5.885. View

Dobkin B . Do electrically stimulated sensory inputs and movements lead to long-term plasticity and rehabilitation gains?. Curr Opin Neurol. 2003; 16(6):685-91. DOI: 10.1097/01.wco.0000102622.38669.ac. View

Adams Jr H, Bendixen B, Kappelle L, Biller J, Love B, Gordon D . Classification of subtype of acute ischemic stroke. Definitions for use in a multicenter clinical trial. TOAST. Trial of Org 10172 in Acute Stroke Treatment. Stroke. 1993; 24(1):35-41. DOI: 10.1161/01.str.24.1.35. View

Tinazzi M, Zarattini S, Valeriani M, Romito S, Farina S, Moretto G . Long-lasting modulation of human motor cortex following prolonged transcutaneous electrical nerve stimulation (TENS) of forearm muscles: evidence of reciprocal inhibition and facilitation. Exp Brain Res. 2004; 161(4):457-64. DOI: 10.1007/s00221-004-2091-y. View

Chan A, Tetzlaff J, Altman D, Laupacis A, Gotzsche P, Krleza-Jeric K . SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013; 158(3):200-7. PMC: 5114123. DOI: 10.7326/0003-4819-158-3-201302050-00583. View

Laufer Y, Elboim-Gabyzon M . Does sensory transcutaneous electrical stimulation enhance motor recovery following a stroke? A systematic review. Neurorehabil Neural Repair. 2011; 25(9):799-809. DOI: 10.1177/1545968310397205. View

Fugl-Meyer A . Post-stroke hemiplegia assessment of physical properties. Scand J Rehabil Med Suppl. 1980; 7:85-93. View

10.

Camak D . Addressing the burden of stroke caregivers: a literature review. J Clin Nurs. 2015; 24(17-18):2376-82. DOI: 10.1111/jocn.12884. View

11.

Nijland R, van Wegen E, Harmeling-van der Wel B, Kwakkel G . Presence of finger extension and shoulder abduction within 72 hours after stroke predicts functional recovery: early prediction of functional outcome after stroke: the EPOS cohort study. Stroke. 2010; 41(4):745-50. DOI: 10.1161/STROKEAHA.109.572065. View

12.

Mathiowetz V, Weber K, Volland G, Kashman N . Reliability and validity of grip and pinch strength evaluations. J Hand Surg Am. 1984; 9(2):222-6. DOI: 10.1016/s0363-5023(84)80146-x. View

13.

Ridding M, McKay D, Thompson P, Miles T . Changes in corticomotor representations induced by prolonged peripheral nerve stimulation in humans. Clin Neurophysiol. 2001; 112(8):1461-9. DOI: 10.1016/s1388-2457(01)00592-2. View

14.

Nakayama H, Jorgensen H, Raaschou H, Olsen T . Recovery of upper extremity function in stroke patients: the Copenhagen Stroke Study. Arch Phys Med Rehabil. 1994; 75(4):394-8. DOI: 10.1016/0003-9993(94)90161-9. View

15.

Wu C, Seo H, Cohen L . Influence of electric somatosensory stimulation on paretic-hand function in chronic stroke. Arch Phys Med Rehabil. 2006; 87(3):351-7. DOI: 10.1016/j.apmr.2005.11.019. View

16.

Golaszewski S, Siedentopf C, Koppelstaetter F, Rhomberg P, Guendisch G, Schlager A . Modulatory effects on human sensorimotor cortex by whole-hand afferent electrical stimulation. Neurology. 2004; 62(12):2262-9. DOI: 10.1212/wnl.62.12.2262. View

17.

Koesler I, Dafotakis M, Ameli M, Fink G, Nowak D . Electrical somatosensory stimulation improves movement kinematics of the affected hand following stroke. J Neurol Neurosurg Psychiatry. 2008; 80(6):614-9. DOI: 10.1136/jnnp.2008.161117. View

18.

Ridding M, Brouwer B, Miles T, Pitcher J, Thompson P . Changes in muscle responses to stimulation of the motor cortex induced by peripheral nerve stimulation in human subjects. Exp Brain Res. 2000; 131(1):135-43. DOI: 10.1007/s002219900269. View

19.

Ikuno K, Kawaguchi S, Kitabeppu S, Kitaura M, Tokuhisa K, Morimoto S . Effects of peripheral sensory nerve stimulation plus task-oriented training on upper extremity function in patients with subacute stroke: a pilot randomized crossover trial. Clin Rehabil. 2012; 26(11):999-1009. DOI: 10.1177/0269215512441476. View

20.

Gladstone D, Danells C, Black S . The fugl-meyer assessment of motor recovery after stroke: a critical review of its measurement properties. Neurorehabil Neural Repair. 2002; 16(3):232-40. DOI: 10.1177/154596802401105171. View