Effects of Mental Practice for Mobility in Post-stroke Hemiparesis

Stroke Clinical Trial

Official title:

Effects of Mental Practice for Mobility in Post-stroke Hemiparesis: Randomized Controlled Trial of Efficacy.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02540096
• Other study ID #: 43659515.4.0000.5103
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2015
• Est. completion date: July 2020

Study information

• Verified date: May 2019
• Source: Federal University of Juiz de Fora
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Stroke is a neurovascular event characterized by impaired blood supply to the brain due to rupture or obstruction of certain cerebral arteries, which often results in hemiparesis and can affect individuals of any age and sex, being prevalent in the elderly population.

Among the main treatments available for stroke rehabilitation, most of them demands an appropriate structure and high-qualified personnel. Searching for more affordable treatment options, several studies suggest the use of mental practice with motor imagery as a potential therapeutic tool, since it can be performed at any place or any time the patient wishes, including their own homes.

Motor imagery can be defined as the covert cognitive process of imagining a movement of your own body(-part) without actually moving that body(-part).

Within this context, the objective of this study is to investigate the effects of mental practice for mobility, gait function and speed and muscle strength of the lower limb in subacute post-stroke hemiparesis.

Description:

Post-stroke patients will be invited to participate after hospital discharge, based on inclusion and exclusion criteria. Then, after acceptance, participants will be randomized (block strategy) into two groups: Control group (Physiotherapy and Cognitive mental exercise) and Intervention group (Physiotherapy and Mental Practice group).

At baseline, 4 weeks (end of intervention) and 6 weeks, participants will be evaluated through the following tests: Timed-Up and Go test, 5-Meter Walk Test, TUG-ABS, WHOQOL-Bref, DASS-21 and muscle strength.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. completion date: July 2020
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 73 Years

Eligibility

Inclusion Criteria:

• hemiparesis after ischemic stroke (15 to 180 days after the event);

• only one cerebral hemisphere affected;

• no chemical, alcohol or drug dependency;

• Score average = 2,5 point in the instrument "Visual and Kinesthetic Imagery Questionnaire" (KIVQ-10);

• No cognitive impairment (18 points in the Mini-Mental State Examination - 0-4 years of educations and 24 points (>4 years of education);

• Not participating in any other type of physiotherapy or physical activity during the study period;

• Complaining of difficulty in gait and mobility after stroke;

• Able to stand up from a chair and walk some distance with or without auxiliary device;

Exclusion Criteria:

• Hemorrhagic or ischemic progressing to hemorrhagic stroke;

• Score = 4 on the Visual Analogue Pain Scale;

• Score = 2 on the modificator Ashworth scale;

• Visual disabilities;

• Severe Aphasia;

• Cardiovascular instability and/or other neurological disorders that may impair the mobility and gait.

Related Conditions & MeSH terms

• Hemiparesis
• Paresis
• Stroke

Intervention

Other:
• Mental practice
The sessions will be individualized and carried out in a peaceful setting.The aim of the mental practice protocol was to promote motor imagery of the following activities: get up from a chair and walk and sit, which enrolls the basic and instrumental activities of daily living. The sessions will consist of six steps: (1) "Physical Practice" (2) "Familiarization" (3) "Memory" (4) "Relaxation" (5) "Repeat" and (6) "post-practice mental relaxation". After the mental practice session, participants will be submitted to individual and structured physiotherapy sessions (the same as the control groups).
• Cognitive training and Relaxation
Cognitive training and relaxation session (lasting 30 minutes, three times a week), totaling 12 sessions. The sessions will consist of calculations, memorization, imagination and body relaxation exercises. These sessions will not have any motor imagery. After the cognitive training and relaxation session, participants will be submitted to individual and structured physiotherapy sessions lasting 40 minutes with muscle strengthening and stretching exercises.

Locations

Country	Name	City	State
Brazil	Zaqueline Fernandes Guerra	Juiz de Fora

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Juiz de Fora

Country where clinical trial is conducted

Brazil, 

References & Publications (18)

Braun S, Kleynen M, van Heel T, Kruithof N, Wade D, Beurskens A. The effects of mental practice in neurological rehabilitation; a systematic review and meta-analysis. Front Hum Neurosci. 2013 Aug 2;7:390. doi: 10.3389/fnhum.2013.00390. eCollection 2013. — View Citation

Decety J. The neurophysiological basis of motor imagery. Behav Brain Res. 1996 May;77(1-2):45-52. Review. — View Citation

Dunsky A, Dickstein R, Marcovitz E, Levy S, Deutsch JE. Home-based motor imagery training for gait rehabilitation of people with chronic poststroke hemiparesis. Arch Phys Med Rehabil. 2008 Aug;89(8):1580-8. doi: 10.1016/j.apmr.2007.12.039. Erratum in: Arch Phys Med Rehabil. 2008 Nov;89(11):2223. Deutsch, Judith [corrected to Deutsch, Judith E]. — View Citation

Hadidi N, Buckwalter K, Lindquist R, Rangen C. Lessons learned in recruitment and retention of stroke survivors. J Neurosci Nurs. 2012 Apr;44(2):105-10. doi: 10.1097/JNN.0b013e3182478c96. — View Citation

Hesse S, Schauer M, Malezic M, Jahnke M, Mauritz KH. Quantitative analysis of rising from a chair in healthy and hemiparetic subjects. Scand J Rehabil Med. 1994 Sep;26(3):161-6. — View Citation

Ietswaart M, Johnston M, Dijkerman HC, Joice S, Scott CL, MacWalter RS, Hamilton SJ. Mental practice with motor imagery in stroke recovery: randomized controlled trial of efficacy. Brain. 2011 May;134(Pt 5):1373-86. doi: 10.1093/brain/awr077. Epub 2011 Apr 22. — View Citation

Jeannerod M. Neural simulation of action: a unifying mechanism for motor cognition. Neuroimage. 2001 Jul;14(1 Pt 2):S103-9. Review. — View Citation

Lotze M, Cohen LG. Volition and imagery in neurorehabilitation. Cogn Behav Neurol. 2006 Sep;19(3):135-40. Review. — View Citation

Malouin F, Richards CL, Doyon J, Desrosiers J, Belleville S. Training mobility tasks after stroke with combined mental and physical practice: a feasibility study. Neurorehabil Neural Repair. 2004 Jun;18(2):66-75. — View Citation

Malouin F, Richards CL, Durand A, Doyon J. Added value of mental practice combined with a small amount of physical practice on the relearning of rising and sitting post-stroke: a pilot study. J Neurol Phys Ther. 2009 Dec;33(4):195-202. doi: 10.1097/NPT.0b013e3181c2112b. — View Citation

Malouin F, Richards CL, Durand A, Doyon J. Clinical assessment of motor imagery after stroke. Neurorehabil Neural Repair. 2008 Jul-Aug;22(4):330-40. doi: 10.1177/1545968307313499. Epub 2008 Mar 6. — View Citation

Malouin F, Richards CL, Jackson PL, Lafleur MF, Durand A, Doyon J. The Kinesthetic and Visual Imagery Questionnaire (KVIQ) for assessing motor imagery in persons with physical disabilities: a reliability and construct validity study. J Neurol Phys Ther. 2007 Mar;31(1):20-9. — View Citation

Page SJ, Dunning K, Hermann V, Leonard A, Levine P. Longer versus shorter mental practice sessions for affected upper extremity movement after stroke: a randomized controlled trial. Clin Rehabil. 2011 Jul;25(7):627-37. doi: 10.1177/0269215510395793. Epub 2011 Mar 22. — View Citation

Page SJ, Levine P, Leonard AC. Effects of mental practice on affected limb use and function in chronic stroke. Arch Phys Med Rehabil. 2005 Mar;86(3):399-402. — View Citation

Page SJ. Mental practice: a promising restorative technique in stroke rehabilitation. Top Stroke Rehabil. 2001 Autumn;8(3):54-63. — View Citation

Paolucci S, Antonucci G, Grasso MG, Morelli D, Troisi E, Coiro P, Bragoni M. Early versus delayed inpatient stroke rehabilitation: a matched comparison conducted in Italy. Arch Phys Med Rehabil. 2000 Jun;81(6):695-700. — View Citation

Sirigu A, Duhamel JR. Motor and visual imagery as two complementary but neurally dissociable mental processes. J Cogn Neurosci. 2001 Oct 1;13(7):910-9. — View Citation

Zhang S, He WB, Chen NH. Causes of death among persons who survive an acute ischemic stroke. Curr Neurol Neurosci Rep. 2014 Aug;14(8):467. doi: 10.1007/s11910-014-0467-3. Review. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Timed Up and Go (TUG)	This is a measure that examines the participant's basic mobility skills by measuring seconds to rise from sitting, walk 3 meters, return, and sitting down	1 week before intervention; 4 weeks after intervention; 6 weeks after intervention
Primary	5-Meter Walk Test	This is a measure that examines the participant's gait speed (cut off 6 seconds)	1 week before intervention; 4 weeks after intervention; 6 weeks after intervention
Secondary	Change in Muscle strength	Hand-held dynamometer (HDD) for measuring lower-limb muscle strength	1 week before intervention; 4 weeks after intervention; 6 weeks after intervention
Secondary	Change in Quality of life	Using World Health Organization Quality of Life Instrument (WHOQOL-Bref)	1 week before intervention; 4 weeks after intervention; 6 weeks after intervention
Secondary	Change in Mental health	Using Depression, anxiety and stress scale (DASS-21)	1 week before intervention; 4 weeks after intervention; 6 weeks after intervention
Secondary	Change in TUG-ABS	The Timed "Up and Go" Assessment of Biomechanical Strategies (TUG-ABS)	1 week before intervention; 4 weeks after intervention; 6 weeks after intervention