NCT03436810

Brief Summary

The objectives of the study will be General Objective is to investigate the effect of TOCCT with MI on gait performance in patients with stroke. Speific Objevtives. Specific Objectives are to compare the effect of TOCCT with MI and TOCCT with education on the spatio-temporal and functional gait variables in patients with stroke, to investigate the spatio-temporal and functional gait variables in patients with stroke after receiving TOCCT with MI and to investigate the spatio-temporal and functional gait variables in patients with stroke after receiving TOCCT with education.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 11, 2018

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2019

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

March 25, 2021

Completed
Last Updated

March 25, 2021

Status Verified

March 1, 2021

Enrollment Period

9 months

First QC Date

February 5, 2018

Results QC Date

February 20, 2020

Last Update Submit

March 2, 2021

Conditions

StrokeGait, Hemiplegic

Keywords

Motor ImageryTask-Oriented Circuit Class TrainingHealth Education

Outcome Measures

Primary Outcomes (2)

  • Change of Gait Speed at 4 Weeks

    Measured by using two dimensional motion analysis

    4 weeks after training

  • Change of Step Length at 4 Weeks

    Measured by using two dimensional motion analysis

    4 weeks after training

Secondary Outcomes (7)

  • Change of Step Time at 4 Weeks

    4 weeks after training

  • Change of Cadence at 4 Weeks

    4 weeks after training

  • Change of 6-minute Walk Score at 4 Weeks

    4 weeks after training

  • Change of Number of Step at 4 Weeks

    4 weeks after training

  • Change of Timed Up and Go Score at 4 Weeks

    4 weeks after training

  • +2 more secondary outcomes

Study Arms (2)

Experimental group

EXPERIMENTAL

The experimental group will receive training programs of Motor imagery (MI) for 25 minutes and Task-Oriented Circuit Class Training (TOCCT) for 65 minutes. Overall duration of program session will be 90 minutes. Training for 3 times a week over duration of 4 weeks.

Procedure: Motor imageryProcedure: Task-Oriented Circuit Class Training

Control group

ACTIVE COMPARATOR

The control group receives programs of Health education (HE) for 25 minutes and Task-Oriented Circuit Class Training (TOCCT) for 65 minutes. Overall duration will be 90 minutes. They will be trained for 3 times a week over duration of 4 weeks.

Procedure: Health educationProcedure: Task-Oriented Circuit Class Training

Interventions

Motor imageryPROCEDURE

Motor imagery (MI) will be trained for the individuals by imagination of the movement. Program of MI includes 1) body relaxation and awareness 2) visual imagery 3) kinesthetic imagery and 4) refocusing of body and environment.

Experimental group
Health educationPROCEDURE

Topic of Health education (HE) consists of 1) Changes caused by stroke 2) Complications after stroke 3) Emotional changes after stroke 4) Living at home after stroke 5) High blood pressure and stroke and 6) Preventing recurrent stroke.

Control group
Task-Oriented Circuit Class TrainingPROCEDURE

Program of Task-Oriented Circuit Class Training (TOCCT) consists of warm up and perform tasks 1) Stepping forward-backward onto block 2) Stepping sideway onto block 3) Heel lifts in standing to strengthen affected planter-flexor muscles 4) Standing with a decreased base and reach for object 5) Standing up from chair, walking a short distance, and returning to chair 6) Symmetrical walking and 7) Walking at fast speed.

Control groupExperimental group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First stroke and paresis on unilateral side of the body
  • Age 18 - 75 years
  • Post-stroke duration 3 - 12 months
  • Middle cerebral artery (MCA) involvement
  • Ability to walk at least 10 meters with or without using assistance
  • Functional Ambulation Category (FAC) more than or equal to 3
  • Mini Mental State Examination (MMSE) more than or equal to 24
  • National Institutes of Health Stroke Scale (NIHSS) lessor than 14
  • MI ability by the Kinesthetic and Visual Imagery Questionnaire (KVIQ-10) more than or equal to 3

You may not qualify if:

  • Unstable cardiopulmonary problems
  • Other neurological conditions such as Parkinson's disease, Alzheimer's disease, or epilepsy
  • Orthopedic and rheumatologic disorders with weight bearing pain
  • Unable to communicate or unable to follow commands
  • Serious cardiac conditions
  • Patients with unilateral spatial neglect
  • Patients with ataxic movement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Medical Technology

Yangon, 11012, Burma

Location

Related Publications (18)

  • Thrift AG, Thayabaranathan T, Howard G, Howard VJ, Rothwell PM, Feigin VL, Norrving B, Donnan GA, Cadilhac DA. Global stroke statistics. Int J Stroke. 2017 Jan;12(1):13-32. doi: 10.1177/1747493016676285. Epub 2016 Oct 28.

    PMID: 27794138BACKGROUND

  • Macko RF, Ivey FM, Forrester LW. Task-oriented aerobic exercise in chronic hemiparetic stroke: training protocols and treatment effects. Top Stroke Rehabil. 2005 Winter;12(1):45-57. doi: 10.1310/PJQN-KAN9-TTVY-HYQH.

    PMID: 15736000BACKGROUND

  • Yang YR, Wang RY, Lin KH, Chu MY, Chan RC. Task-oriented progressive resistance strength training improves muscle strength and functional performance in individuals with stroke. Clin Rehabil. 2006 Oct;20(10):860-70. doi: 10.1177/0269215506070701.

    PMID: 17008338BACKGROUND

  • Cicinelli P, Marconi B, Zaccagnini M, Pasqualetti P, Filippi MM, Rossini PM. Imagery-induced cortical excitability changes in stroke: a transcranial magnetic stimulation study. Cereb Cortex. 2006 Feb;16(2):247-53. doi: 10.1093/cercor/bhi103. Epub 2005 May 4.

    PMID: 15872152BACKGROUND

  • Kim JS, Oh DW, Kim SY, Choi JD. Visual and kinesthetic locomotor imagery training integrated with auditory step rhythm for walking performance of patients with chronic stroke. Clin Rehabil. 2011 Feb;25(2):134-45. doi: 10.1177/0269215510380822. Epub 2010 Oct 13.

    PMID: 20943715BACKGROUND

  • Balasubramanian CK, Neptune RR, Kautz SA. Variability in spatiotemporal step characteristics and its relationship to walking performance post-stroke. Gait Posture. 2009 Apr;29(3):408-14. doi: 10.1016/j.gaitpost.2008.10.061. Epub 2008 Dec 3.

    PMID: 19056272BACKGROUND

  • Billinger SA, Arena R, Bernhardt J, Eng JJ, Franklin BA, Johnson CM, MacKay-Lyons M, Macko RF, Mead GE, Roth EJ, Shaughnessy M, Tang A; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Lifestyle and Cardiometabolic Health; Council on Epidemiology and Prevention; Council on Clinical Cardiology. Physical activity and exercise recommendations for stroke survivors: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Aug;45(8):2532-53. doi: 10.1161/STR.0000000000000022. Epub 2014 May 20.

    PMID: 24846875RESULT

  • Brandstater ME, de Bruin H, Gowland C, Clark BM. Hemiplegic gait: analysis of temporal variables. Arch Phys Med Rehabil. 1983 Dec;64(12):583-7.

    PMID: 6661021RESULT

  • Jorgensen L, Crabtree NJ, Reeve J, Jacobsen BK. Ambulatory level and asymmetrical weight bearing after stroke affects bone loss in the upper and lower part of the femoral neck differently: bone adaptation after decreased mechanical loading. Bone. 2000 Nov;27(5):701-7. doi: 10.1016/s8756-3282(00)00374-4.

    PMID: 11062359RESULT

  • Verma R, Arya KN, Garg RK, Singh T. Task-oriented circuit class training program with motor imagery for gait rehabilitation in poststroke patients: a randomized controlled trial. Top Stroke Rehabil. 2011 Oct;18 Suppl 1:620-32. doi: 10.1310/tsr18s01-620.

    PMID: 22120031RESULT

  • English C, Hillier SL, Lynch EA. Circuit class therapy for improving mobility after stroke. Cochrane Database Syst Rev. 2017 Jun 2;6(6):CD007513. doi: 10.1002/14651858.CD007513.pub3.

    PMID: 28573757RESULT

  • Guillot A, Collet C. Contribution from neurophysiological and psychological methods to the study of motor imagery. Brain Res Brain Res Rev. 2005 Dec 15;50(2):387-97. doi: 10.1016/j.brainresrev.2005.09.004. Epub 2005 Nov 3.

    PMID: 16271398RESULT

  • Malouin F, Richards CL, Jackson PL, Dumas F, Doyon J. Brain activations during motor imagery of locomotor-related tasks: a PET study. Hum Brain Mapp. 2003 May;19(1):47-62. doi: 10.1002/hbm.10103.

    PMID: 12731103RESULT

  • 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: 18674992RESULT

  • Zimmermann-Schlatter A, Schuster C, Puhan MA, Siekierka E, Steurer J. Efficacy of motor imagery in post-stroke rehabilitation: a systematic review. J Neuroeng Rehabil. 2008 Mar 14;5:8. doi: 10.1186/1743-0003-5-8.

    PMID: 18341687RESULT

  • Aung N, Bovonsunthonchai S, Hiengkaew V, Tretriluxana J, Rojasavastera R, Pheung-Phrarattanatrai A. Concurrent validity and intratester reliability of the video-based system for measuring gait poststroke. Physiother Res Int. 2020 Jan;25(1):e1803. doi: 10.1002/pri.1803. Epub 2019 Aug 16.

    PMID: 31418511RESULT

  • Bandinelli S, Benvenuti E, Del Lungo I, Baccini M, Benvenuti F, Di Iorio A, Ferrucci L. Measuring muscular strength of the lower limbs by hand-held dynamometer: a standard protocol. Aging (Milano). 1999 Oct;11(5):287-93. doi: 10.1007/BF03339802.

    PMID: 10631877RESULT

  • Lin PY, Yang YR, Cheng SJ, Wang RY. The relation between ankle impairments and gait velocity and symmetry in people with stroke. Arch Phys Med Rehabil. 2006 Apr;87(4):562-8. doi: 10.1016/j.apmr.2005.12.042.

    PMID: 16571398RESULT

MeSH Terms

Conditions

StrokeGait Disorders, NeurologicHealth Education

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Results Point of Contact

Title
Sunee Bovonsunthonchai
Organization
Mahidol University
sunee.bov@mahidol.edu
024415450

Study Officials

  • Sunee Bovonsunthonchai, PhD

    Faculty of Physical Therapy, Mahidol University

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2018

First Posted

February 19, 2018

Study Start

January 11, 2018

Primary Completion

October 10, 2018

Study Completion

January 10, 2019

Last Updated

March 25, 2021

Results First Posted

March 25, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

BU(1)