StrokeNCT04086004
Dual Task Balance Training With Additional Motor Imagery Practice in Stroke
A study testing Group I Experimental Motor Imagery and Dual task training in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
The importance of potent rehabilitation with dual task balance and gait training is improving and also there have been divergent opinions about the effectiveness of Motor Imagery on balance and gait function. Dual tasking has also proved beneficial results on stroke patients. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- Group I Experimental Motor Imagery and Dual task training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2020to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Modified Rankin scale disability level 2-3
- Sub acute and chronic stroke patients.
- Ability to walk independently over ground for at least 10 m with or without use of an assistive device
- absence of any cognitive impairment
- No significant body or visual spatial hemi-neglect,
- Good ability for imagery functioning (a score of 32 or higher on the revision of Movement Imagery Questionnaire)
Who cannot join
- -The patient will be excluded if he/she reported serious visual or somatosensory, orthopedic impairments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Additional Effects of Motor Imagery Practice With Dual Task Training in Stroke Patients
The importance of potent rehabilitation with dual task balance and gait training is improving and also there have been divergent opinions about the effectiveness of Motor Imagery on balance and gait function. Dual tasking has also proved beneficial results on stroke patients. Mental stimulation with task performance is a new intervention.. So the purpose of my study is to investigate the combination of Motor Imagery Practice and dual task rehabilitative training on balance and gait targeting the population of post stroke patients
Read the detailed description
Stroke is a disease which occurs when the blood flow to the brain is cut off due to hemorrhage or ischemia in the blood vessels.Stroke is the second leading cause of death and a major cause of disability worldwide. Its incidence is increasing because the population ages . The quantity of individuals influenced by stroke will unavoidably ascend as global life expectancy increases. The frequency of motor deficits following a stroke can be up to 80% in a defined elderly population. Only a small percentage of this group (approximately 20%) will partially recover from impaired motor ability, leaving approximately 50-60% who are left with some form of chronic motor deficiency the burden of stroke seems to be high in Pakistan as in other south Asian countries. Not only the mean age of patients with stroke is less compared to patients in the developed world, approximately 20% of patients are under the age of 45 years. Hypertension is by far the most common risk factor also in young stroke patients. Hypertension and other conventional risk factors are highly prevalent in the country.To function in daily life, an individual must be able to maintain and adopt various postures, react to external disturbances, and use automatic postural responses that precede voluntary movements. A major focus of rehabilitation programs, therefore, is to improve balance and optimize function and mobility.Balance is the ability to maintain the body's center of mass over its base of support. Balance is a term used to describe the ability of a person to maintain or move within a weight-bearing posture without falling.Stroke patients experience various symptoms such as sensory disorder ,mobility defects and cognitive disorder which negatively affect functions for carrying out activities of daily living.The inability of stroke survivors to swing the involved leg rapidly might be the most critical factor adding to the enormous number of falls to the paretic side.balance and gait ability revival is a critical goal in stroke rehabilitation. A variety of interventions, such as virtual reality, robotics and mental practice with motor imagery, have been studied to improve the gait ability of stroke patients.Cognitive-motor and motor dual tasks assume significant role in day by day life: strolling while at the same time talking, utilizing a cell phone, carrying a pack or watching traffic.The dual-task program is effective in improving dual-task mobility, reducing falls and fall-related injuries in ambulatory chronic stroke patients with intact cognition. During dual-tasking, individuals with stroke have shown more pronounced performance decreasing in either the cognitive, mobility, or both tasks, compared with healthy older adults (ie, cognitive-motor interference) Mental practice is a new rehabilitation method that refers to the mental rehearsal of motor imagery content with the goal of improving motor performance.Motor imagery training is a helpful elective methodology for physical recovery following stroke, and offers protected, accessible, and cheap treatment strategy that is the utilization at home without specific equipments. Motor imagery training is free from physical execution of a disabled limb, and takes into account utilization of the mind to in restoring the circuitry that mediates voluntary movement. The preparation can make cortical plasticity changes like those made after physical action, in this way, these systems point to the capability of utilizing motor imagery practice in the neurological recovery of people following stroke.Hui yang cho et al concluded that Gait training with motor imagery training improves the balance and gait abilities of chronic stroke patients significantly better than gait training alone . According to recent study, conducted by Young Hyeon Bae et al. concluded that specific balance training with motor imagery is much beneficial and improve both balance and gait. Gye Yeop Kim et al found that dual-task training improves cognitive and walking abilities of patients with stroke.In another study conducted by Gui Bin Song et al reported that dual task training is more effective for increasing balance ability.
- Conditions
- Stroke
- Being tested
- Group I Experimental Motor Imagery, Dual task training
- Keywords
- Motor Imagery practice, Stroke, Dual task training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group I Experimental Motor ImageryOther
Also called Group II Experimental Dual Task Training
The experimental group will receive dual task balance training for 30 minutes/day with additional mental imagery for 10 minutes/day, three days/week, for a period of eight weeks
Dual task trainingOther
group will receive dual task balance training for 40 minutes for three days/ week for eight weeks
| Study group | Role | What they receive |
|---|---|---|
| Group I Experimental Motor Imagery | Experimental | Motor imagery practice Receives: Other: Group I Experimental Motor Imagery |
| Group II Dual Task Training | Experimental | Dual-task balance training Receives: Other: Dual task training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg balance scale
The Berg balance scale (BBS) is used to assess the participant's ability to retain stability. The BBS is a widely used test for the assessment of elderly population with impairment of balance and individuals with neurological disorder while sitting, standing, and transferring. This test included both static and dynamic type task. The BBS uses a five-point ordinal scale ranging from 0 (disability) to 4(complete independent performance) and consists of 14 components; the maximum score is 56 points. The scale has been shown to be reliable and valid in stroke patients. A cut-off score of 45 points is used for fall prediction. The BBS involves 14 tasks; a total score of 56. Equipment required for this test were a stop watch or watch with a second's hand and a ruler or other indicator of 2, 5, and 10 inches. Excellent reliability (ICC range, 0.98-0.99) has been found in individuals with stroke survivors for BBS
Measured: Change from Baseline balance to 8 Weeks
Timed Up and Go test
The Timed Up and Go (TUG) test was designed for the evaluation of balance and Measures mobility in people who are able to walk on their own (assistive device permitted) to find out the risk of fall . The subjects will be required to stand up from a chair, walk 3 m, turn around, return to the chair, and sit down. The time taken to complete this task will be measured. The test will be informed three times. The time required to complete this task will be measured from a stopwatch. The average values from 3 trials, with 1-min rest between each trial, were used for data analysis. This test has excellent reliability (ICC > 0.95) with stroke survivors
Measured: Change from Baseline balance and mobility to 8 Weeks
Functional reach Test:
The patient is instructed to stand alongside a wall, however not contacting, a wall and position the arm that is nearer to the wall at 90 degrees of shoulder flexion with a closed fist. The assessor records the beginning position at the third metacarpal head on the measuring stick. Teach the patient to "Reach the extent that you can forward without taking a step." The area of the third metacarpal is recorded before and after a maximal forward reach. The mean score of three successful trials was calculated. Test-retest reliability of FR is high (interclass correlation coefficient (ICC) = 0.92) as interrater reliability is (ICC = 0.98)
Measured: Change from Baseline balance to 8 Weeks
Secondary outcomes (1)
Fugl Meyer Scale (FMS)
Changes from the Baseline this scale was measured
Fugl Meyer Assessment is the utmost extensively used and approved clinical scale for assessment of sensorimotor loss in post stroke patients.This scale is comprised of five domains and there are 155 items in total:
- Motor functioning (in the upper and lower extremities)
- Sensory functioning (evaluates light touch on two surfaces of the arm and leg, and position sense for 8 joints)
- Balance (contains 7 tests, 3 seated and 4 standing)
- Joint range of motion (8 joints)
- Joint pain 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible scale score is 226.
MAS detecting the changes in muscle tone in patients with stroke.. It's a 6 point scale. 0=no muscle tone, 4= affected parts rigid flexion or extension.Its reliability is 0.567.
Measured: Change from Baseline to 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start1 Apr 2020
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Misbah Ghous, MsNMPT, Principal investigator, Riphah International University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086004
- Sponsor's protocol ID
- Maria Zafar REC/00554
- Status last verified
- Oct 2020
- First submitted
- 4 Sep 2019
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Walker C, Brouwer BJ, Culham EG. Use of visual feedback in retraining balance following acute stroke. Phys Ther. 2000 Sep;80(9):886-95.
PubMed 10960936Khealani BA, Hameed B, Mapari UU. Stroke in Pakistan. J Pak Med Assoc. 2008 Jul;58(7):400-3.
PubMed 18988415Kim SS, Lee HJ, You YY. Effects of ankle strengthening exercises combined with motor imagery training on the timed up and go test score and weight bearing ratio in stroke patients. J Phys Ther Sci. 2015 Jul;27(7):2303-5. doi: 10.1589/jpts.27.2303. Epub 2015 Jul 22.
PubMed 26311971Kenyon LK, Blackinton MT. Applying motor-control theory to physical therapy practice: a case report. Physiother Can. 2011 Summer;63(3):345-54. doi: 10.3138/ptc.2010-06. Epub 2011 Aug 10.
PubMed 22654241Melzer I, Goldring M, Melzer Y, Green E, Tzedek I. Voluntary stepping behavior under single- and dual-task conditions in chronic stroke survivors: A comparison between the involved and uninvolved legs. J Electromyogr Kinesiol. 2010 Dec;20(6):1082-7. doi: 10.1016/j.jelekin.2010.07.001. Epub 2010 Aug 2.
PubMed 20675152
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additional Effects of Motor Imagery Practice With Dual Task Training in Stroke Patients
- ClinicalTrials.gov ID
- NCT04086004
- Acronym / sponsor ID
- Maria Zafar REC/00554
- Conditions
- Stroke
- Keywords
- Motor Imagery practice, Stroke, Dual task training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 11 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The importance of potent rehabilitation with dual task balance and gait training is improving and also there have been divergent opinions about the effectiveness of Motor Imagery on balance and gait function. Dual tasking has also proved beneficial results on stroke patients. Mental stimulation with task performance is a new intervention.. So the purpose of my study is to investigate the combination of Motor Imagery Practice and dual task rehabilitative training on balance and gait targeting the population of post stroke patients
Detailed description
Stroke is a disease which occurs when the blood flow to the brain is cut off due to hemorrhage or ischemia in the blood vessels.Stroke is the second leading cause of death and a major cause of disability worldwide. Its incidence is increasing because the population ages . The quantity of individuals influenced by stroke will unavoidably ascend as global life expectancy increases. The frequency of motor deficits following a stroke can be up to 80% in a defined elderly population. Only a small percentage of this group (approximately 20%) will partially recover from impaired motor ability, leaving approximately 50-60% who are left with some form of chronic motor deficiency the burden of stroke seems to be high in Pakistan as in other south Asian countries. Not only the mean age of patients with stroke is less compared to patients in the developed world, approximately 20% of patients are under the age of 45 years. Hypertension is by far the most common risk factor also in young stroke patients. Hypertension and other conventional risk factors are highly prevalent in the country.To function in daily life, an individual must be able to maintain and adopt various postures, react to external disturbances, and use automatic postural responses that precede voluntary movements. A major focus of rehabilitation programs, therefore, is to improve balance and optimize function and mobility.Balance is the ability to maintain the body's center of mass over its base of support. Balance is a term used to describe the ability of a person to maintain or move within a weight-bearing posture without falling.Stroke patients experience various symptoms such as sensory disorder ,mobility defects and cognitive disorder which negatively affect functions for carrying out activities of daily living.The inability of stroke survivors to swing the involved leg rapidly might be the most critical factor adding to the enormous number of falls to the paretic side.balance and gait ability revival is a critical goal in stroke rehabilitation. A variety of interventions, such as virtual reality, robotics and mental practice with motor imagery, have been studied to improve the gait ability of stroke patients.Cognitive-motor and motor dual tasks assume significant role in day by day life: strolling while at the same time talking, utilizing a cell phone, carrying a pack or watching traffic.The dual-task program is effective in improving dual-task mobility, reducing falls and fall-related injuries in ambulatory chronic stroke patients with intact cognition. During dual-tasking, individuals with stroke have shown more pronounced performance decreasing in either the cognitive, mobility, or both tasks, compared with healthy older adults (ie, cognitive-motor interference) Mental practice is a new rehabilitation method that refers to the mental rehearsal of motor imagery content with the goal of improving motor performance.Motor imagery training is a helpful elective methodology for physical recovery following stroke, and offers protected, accessible, and cheap treatment strategy that is the utilization at home without specific equipments. Motor imagery training is free from physical execution of a disabled limb, and takes into account utilization of the mind to in restoring the circuitry that mediates voluntary movement. The preparation can make cortical plasticity changes like those made after physical action, in this way, these systems point to the capability of utilizing motor imagery practice in the neurological recovery of people following stroke.Hui yang cho et al concluded that Gait training with motor imagery training improves the balance and gait abilities of chronic stroke patients significantly better than gait training alone . According to recent study, conducted by Young Hyeon Bae et al. concluded that specific balance training with motor imagery is much beneficial and improve both balance and gait. Gye Yeop Kim et al found that dual-task training improves cognitive and walking abilities of patients with stroke.In another study conducted by Gui Bin Song et al reported that dual task training is more effective for increasing balance ability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I Experimental Motor Imagery | Experimental | Other: Group I Experimental Motor ImageryMotor imagery practice |
| Group II Dual Task Training | Experimental | Other: Dual task trainingDual-task balance training |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Modified Rankin scale disability level 2-3
- Sub acute and chronic stroke patients.
- Ability to walk independently over ground for at least 10 m with or without use of an assistive device
- absence of any cognitive impairment
- No significant body or visual spatial hemi-neglect,
Key exclusion criteria (1 listed)
- -The patient will be excluded if he/she reported serious visual or somatosensory, orthopedic impairments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group I Experimental Motor ImageryAlso: Group II Experimental Dual Task TrainingThe experimental group will receive dual task balance training for 30 minutes/day with additional mental imagery for 10 minutes/day, three days/week, for a period of eight weeks | Other | Group I Experimental Motor Imagery |
| Dual task traininggroup will receive dual task balance training for 40 minutes for three days/ week for eight weeks | Other | Group II Dual Task Training |
Primary outcome
Berg balance scale
Time frame: Change from Baseline balance to 8 Weeks
The Berg balance scale (BBS) is used to assess the participant's ability to retain stability. The BBS is a widely used test for the assessment of elderly population with impairment of balance and individuals with neurological disorder while sitting, standing, and transferring. This test included both static and dynamic type task. The BBS uses a five-point ordinal scale ranging from 0 (disability) to 4(complete independent performance) and consists of 14 components; the maximum score is 56 points. The scale has been shown to be reliable and valid in stroke patients. A cut-off score of 45 points is used for fall prediction. The BBS involves 14 tasks; a total score of 56. Equipment required for this test were a stop watch or watch with a second's hand and a ruler or other indicator of 2, 5, and 10 inches. Excellent reliability (ICC range, 0.98-0.99) has been found in individuals with stroke survivors for BBS
Timed Up and Go test
Time frame: Change from Baseline balance and mobility to 8 Weeks
The Timed Up and Go (TUG) test was designed for the evaluation of balance and Measures mobility in people who are able to walk on their own (assistive device permitted) to find out the risk of fall . The subjects will be required to stand up from a chair, walk 3 m, turn around, return to the chair, and sit down. The time taken to complete this task will be measured. The test will be informed three times. The time required to complete this task will be measured from a stopwatch. The average values from 3 trials, with 1-min rest between each trial, were used for data analysis. This test has excellent reliability (ICC > 0.95) with stroke survivors
Functional reach Test:
Time frame: Change from Baseline balance to 8 Weeks
The patient is instructed to stand alongside a wall, however not contacting, a wall and position the arm that is nearer to the wall at 90 degrees of shoulder flexion with a closed fist. The assessor records the beginning position at the third metacarpal head on the measuring stick. Teach the patient to "Reach the extent that you can forward without taking a step." The area of the third metacarpal is recorded before and after a maximal forward reach. The mean score of three successful trials was calculated. Test-retest reliability of FR is high (interclass correlation coefficient (ICC) = 0.92) as interrater reliability is (ICC = 0.98)
1 secondary outcome
Fugl Meyer Scale (FMS)
Time frame: Change from Baseline to 8 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Background: PubMed 10960936Walker C, Brouwer BJ, Culham EG. Use of visual feedback in retraining balance following acute stroke. Phys Ther. 2000 Sep;80(9):886-95.
- Background: PubMed 18988415Khealani BA, Hameed B, Mapari UU. Stroke in Pakistan. J Pak Med Assoc. 2008 Jul;58(7):400-3.
- Background: PubMed 26311971Kim SS, Lee HJ, You YY. Effects of ankle strengthening exercises combined with motor imagery training on the timed up and go test score and weight bearing ratio in stroke patients. J Phys Ther Sci. 2015 Jul;27(7):2303-5. doi: 10.1589/jpts.27.2303. Epub 2015 Jul 22.
- Background: PubMed 22654241Kenyon LK, Blackinton MT. Applying motor-control theory to physical therapy practice: a case report. Physiother Can. 2011 Summer;63(3):345-54. doi: 10.3138/ptc.2010-06. Epub 2011 Aug 10.
- Background: PubMed 20675152Melzer I, Goldring M, Melzer Y, Green E, Tzedek I. Voluntary stepping behavior under single- and dual-task conditions in chronic stroke survivors: A comparison between the involved and uninvolved legs. J Electromyogr Kinesiol. 2010 Dec;20(6):1082-7. doi: 10.1016/j.jelekin.2010.07.001. Epub 2010 Aug 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Misbah Ghous, MsNMPT principal investigator
Riphah International University Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group I Experimental Motor Imagery and Dual task training in people with Stroke, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg balance scale (time frame: Change from Baseline balance to 8 Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04086004, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.