NCT02540096

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

May 23, 2019

Status Verified

May 1, 2019

Enrollment Period

3.2 years

First QC Date

September 1, 2015

Last Update Submit

May 21, 2019

Conditions

Keywords

mental practicemotor imageryhemiparesisstrokegaitmobility

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • Change in Muscle strength

    1 week before intervention; 4 weeks after intervention; 6 weeks after intervention

  • Change in Quality of life

    1 week before intervention; 4 weeks after intervention; 6 weeks after intervention

  • Change in Mental health

    1 week before intervention; 4 weeks after intervention; 6 weeks after intervention

  • Change in TUG-ABS

    1 week before intervention; 4 weeks after intervention; 6 weeks after intervention

Study Arms (2)

Intervention (Mental Practice)

EXPERIMENTAL

Participants will be submitted to individual and structured physiotherapy sessions (the same as the control groups). They will also participate in a structured mental practice session (lasting 30 minutes and three times a week), totaling 12 sessions at the end of this intervention.

Other: Mental practice

Control group

PLACEBO COMPARATOR

Participants will be submitted to individual and structured physiotherapy sessions lasting 40 minutes. They will also participate in a cognitive training and relaxation session (lasting 30 minutes, three times a week), totaling 12 sessions.

Other: Cognitive training and Relaxation

Interventions

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).

Intervention (Mental Practice)

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.

Control group

Eligibility Criteria

Age18 Years - 73 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zaqueline Fernandes Guerra

Juiz de Fora, 36038295, Brazil

Location

Related Publications (19)

  • 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. doi: 10.1016/s0003-9993(00)90095-9.

    PMID: 10857508BACKGROUND
  • 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.

    PMID: 22367274BACKGROUND
  • 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.

    PMID: 24951970BACKGROUND
  • 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.

    PMID: 21427151BACKGROUND
  • Page SJ. Mental practice: a promising restorative technique in stroke rehabilitation. Top Stroke Rehabil. 2001 Autumn;8(3):54-63. doi: 10.1310/7WDU-2P4U-V2EA-76F8.

    PMID: 14523738BACKGROUND
  • 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. doi: 10.1016/j.apmr.2004.10.002.

    PMID: 15759218BACKGROUND
  • Lotze M, Cohen LG. Volition and imagery in neurorehabilitation. Cogn Behav Neurol. 2006 Sep;19(3):135-40. doi: 10.1097/01.wnn.0000209875.56060.06.

    PMID: 16957491BACKGROUND
  • 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. doi: 10.1162/089892901753165827.

    PMID: 11595094BACKGROUND
  • Jeannerod M. Neural simulation of action: a unifying mechanism for motor cognition. Neuroimage. 2001 Jul;14(1 Pt 2):S103-9. doi: 10.1006/nimg.2001.0832.

    PMID: 11373140BACKGROUND
  • 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. doi: 10.1097/01.npt.0000260567.24122.64.

    PMID: 17419886BACKGROUND
  • 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. doi: 10.1177/0888439004266304.

    PMID: 15228801BACKGROUND
  • 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.

    PMID: 20208464BACKGROUND
  • 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.

    PMID: 18326057BACKGROUND
  • 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.

    PMID: 7801066BACKGROUND
  • Decety J. The neurophysiological basis of motor imagery. Behav Brain Res. 1996 May;77(1-2):45-52. doi: 10.1016/0166-4328(95)00225-1.

    PMID: 8762158BACKGROUND
  • 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.

    PMID: 18674992BACKGROUND
  • 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.

    PMID: 23935572BACKGROUND
  • 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.

    PMID: 21515905BACKGROUND
  • Guerra ZF, Bellose LC, Ferreira AP, Faria CDCM, Paz CCSC, Lucchetti G. Effects of mental practice on mobility of individuals in the early subacute post-stroke phase: A randomized controlled clinical trial. J Bodyw Mov Ther. 2022 Oct;32:82-90. doi: 10.1016/j.jbmt.2022.04.018. Epub 2022 Apr 27.

MeSH Terms

Conditions

StrokeParesis

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Zaqueline F Guerra

    Federal University of Juiz de Fora

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

September 1, 2015

First Posted

September 3, 2015

Study Start

November 1, 2015

Primary Completion

January 1, 2019

Study Completion

July 1, 2020

Last Updated

May 23, 2019

Record last verified: 2019-05

Locations