Effect of Structured Progressive Task-Oriented Circuit Class Training With Motor Imagery on Gait in Stroke

Stroke Clinical Trial

Official title:

Effect of a Structured Progressive Task-Oriented Circuit Class Training Program With Motor Imagery on Gait Performance in Patients With Stroke: A Randomized Double Blind Balanced Parallel-Group

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03436810
• Other study ID #: MU-CIRB 2017/178.1010
• Status: Completed
• Phase: N/A
• Start date: January 11, 2018
• Est. completion date: January 10, 2019

Study information

• Verified date: March 2021
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study will use a sample of convenience between the ages of 18-75 years. Forty patients with stroke from the departments of physical medicine and rehabilitation, North Okkalapa General Hospital, East General Hospital and National Rehabilitation Hospital, Yangon, Myanmar will participate in this study. The sample size was calculated using the mean value of gait speed from the previous study. Probability of type I error, apha value at 0.05 and power of 0.80 were set.

All participants will be explained about details of the study and the interventions. After that, they will be asked to sign on the written consent approving by the committee of the institution prior to participate in study. All participants will be randomly allocated the participants into the experimental (TOCCT with MI) or the control (TOCCT with health education) groups. All participants will be screened following the criteria and will be collected the demographic data.

All outcome measures will be assessed by the therapist who have been trained the outcome measures of the study. As the primary outcome measurements, spatio-temporal variables will be measured by using two dimensional motion analysis method. The protocol of this method was proved to be valid and reliability from previous pilot study. For functional gait variables, six-minute walk test will be assessed for determining walking endurance, step test will be assessed for dynamic balance, and Timed Up and Go (TUG) test will be assessed for mobility function.

As the secondary outcome measure, the strength of hip flexor, hip extensor, knee flexor, knee extensor, ankle dorsiflexor, and ankle plantarflexor muscles will be assessed by using hand-held dynamometer. Muscle spasticity will be assessed by using the Modified Ashworth Scale (MAS). The outcome measures will be assessed at the baseline, after 2 weeks and 4 weeks intervention. For the safety, the therapist will measure blood pressure, pulse rate and fatigue level in the assessments, just before the training, and rest period during the training program.

Both groups will receive the same 65 minutes structured progressive TOCCT and will receive 25 minutes of MI training for the experimental group and 25 minutes of health education for the control group. So, total training duration will be 90 minutes. Intervention program will provide 3 times a week over a period of 4 weeks.

Descriptive statistic will be used for analyze the demographic and baseline characteristics of the participants. To clarify whether the data are normally distributed, the Kolmogorov Smirnov Goodness of Fit test will be used. If data are normally distributed, two-way mixed repeated measure ANOVA will be used. If the data are not normally distributed, Friedman test will be used to compare the mean differences of the spatio-temporal measures, 6 minutes walk test, step test, TUG test, muscle strength test and muscle spasticity test. The significant level is set at p < 0.05.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 10, 2019
• Est. primary completion date: October 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Gait, Hemiplegic
• Stroke

Intervention

Procedure:
• Motor imagery
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.
• Health education
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.
• Task-Oriented Circuit Class Training
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.

Locations

Country	Name	City	State
Myanmar	University of Medical Technology	Yangon

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Myanmar, 

References & Publications (18)

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. — View Citation

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. — View Citation

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. — View Citation

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 Cardi — View Citation

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. — View Citation

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. Epub 2005 May 4. — 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: Arc — View Citation

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

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. Epub 2005 Nov 3. Review. — View Citation

Jørgensen 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 — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. 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 of Gait Speed at 4 Weeks	Measured by using two dimensional motion analysis	4 weeks after training
Primary	Change of Step Length at 4 Weeks	Measured by using two dimensional motion analysis	4 weeks after training
Secondary	Change of Step Time at 4 Weeks	measured by using two dimensional motion analysis	4 weeks after training
Secondary	Change of Cadence at 4 Weeks	measured by using two dimensional motion analysis	4 weeks after training
Secondary	Change of 6-minute Walk Score at 4 Weeks	The changed score measured by using the 6-minute walk test. The higher changed scores mean a better outcome.	4 weeks after training
Secondary	Change of Number of Step at 4 Weeks	The changed score is measured by using the step test, The higher score means better outcome.	4 weeks after training
Secondary	Change of Timed Up and Go Score at 4 Weeks	The changed score is measured by using the Timed Up and Go test. The higher of changed score mean a worse outcome.	4 weeks after training
Secondary	Change of Muscle Strength at 4 Weeks	The change score of muscle strength is measured by the hand-held dynamometer	4 weeks after training
Secondary	Change of Muscle Tone at 4 Weeks	The change score is measured by using the modified Ashworth Scale for each muscle group, the minimum and maximum scores of muscle tone are 0 and 4, respectively. A higher score of tone means a worse outcome.	4 weeks after training