StrokeNCT05338918
Effect of Mental Imagery on Lower Limb Functions in Stroke
A study testing Mental Imagery with Virtual Reality Training and Virtual Reality Training in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study aims to compare the effects of mental imagery and virtual reality training with virtual reality alone on lower limb functional status of stroke patients. The study will be a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Stroke
- What is being tested?
- Mental Imagery with Virtual Reality Training and Virtual Reality Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 27 Apr 2022to 5 Feb 2023
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with sub-acute/ chronic stroke (>3 months)
- Modified Ashworth Ranking Scale 1-3
- Montreal Cognitive Assessment scoring >24-30
Who cannot join
- Any active pathological condition
- Visual or hearing impairment
- Neurological conditions like Epilepsy, Parkinson, Alzheimer's, Impaired cognition
- Orthopedic issues hindering Mobility Substantially (Fractures, Severe Degenerative Joint Diseases etc.)
- Psychological issues
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Mental Imagery With Virtual Reality Training on Lower Limb Functions in Stroke
This study aims to compare the effects of mental imagery and virtual reality training with virtual reality alone on lower limb functional status of stroke patients. The study will be a randomized controlled trial. After the initial evaluation randomization will be done on participants lying under the eligibility criteria. Randomized participants will be allocated to Control \& Experimental groups. Mental imagery (Audiotape recordings of some specific tasks for lower limb functions) with Virtual reality training given to experimental group while Virtual reality training alone to Control group. Task oriented training for balance \& gait as baseline treatment will be given to each group.
Read the detailed description
Stroke causes inability to perform activities with affected limbs among which difficulty in walking and doing house chores are the most common dysfunctions. Stroke highly affects the productivity of people in family as well as in community. It also adds financial burden on families of patients. There are number of different restorative techniques and therapeutic approaches for the rehabilitation of stroke patients. For example, bobath approach, constrained induced movement therapy, mirror therapy, electrical stimulations, Circuit training, resistance training, Motor relearning program, proprioceptive neuromuscular facilitation, body weight supported treadmill for walking, Frenkel's exercises, repetitive task specific training, electromyography biofeedback and many others. All these approaches mainly focused on the repetition of tasks to perform a specific function, as the neuroplasticity requires repetition to occur. But there is a lack of interest, motivation and attention of stroke patients to perform similar tasks repeatedly. The lack of active participation directly or indirectly affects the neural stimulation and neural plasticity. One of the most emerging techniques in these days is Mental Imagery. Mental imagery(MI) is "a training method where imagination of movements, without actually moving, is used with the intention of improving motor performance" Currently Mental imagery has been used for neuro rehabilitation as it activates the same brain areas required for planning and execution of movements more or less in the same way require for actual performance of that movement. In this study the combination for Mental imagery and virtual reality is used for participation of patients in rehabilitation program which in turn increases the neural stimulation and causes neural plasticity to improve the motor performance. By increasing the functional activity, their ADL's can be improved to help them in becoming the active member of the society.
- Conditions
- Stroke
- Being tested
- Mental Imagery with Virtual Reality Training, Virtual Reality Training
- Keywords
- Lower limb, Impairment, Mental practice, Virtual Reality training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental Imagery with Virtual Reality TrainingOther
Mental Imagery TASK Practice with Virtual Reality Training: 30-40 minutes treatment sessions will be performed three times a week for six weeks, Part 1: 2-3 minutes of relaxation Part 2: Visual Imagery (external motor imagery training) for 5-8 minutes Part 3: Actual Task Practice for 10 minutes Part 4: Virtual Reality based training (including games for lower limb functions) for 10 minutes Part 5:Task Oriented training for 10 minutes Tasks for both (mental imagery + actual task practice) will be: Sit-stand task, Static stance (30 seconds), Indoor walk on a leveled surface, Walk indoor towards target, Forward / Side Stepping, Walking outdoors
Virtual Reality TrainingOther
Virtual Reality Training: 30-40 minutes treatment sessions will be performed three times a week for six weeks. Games will include River rush, 20000 water leaks, reflex ridge along with task oriented training. Tasks will be: Sit-stand task, Static stance (30 seconds), Indoor walk on a leveled surface, Walk indoor towards target, Forward / Side Stepping, Walking outdoors
| Study group | Role | What they receive |
|---|---|---|
| Mental Imagery with Virtual Reality Group | Experimental | Mental Imagery with Virtual Reality Receives: Other: Mental Imagery with Virtual Reality Training |
| Virtual Reality Alone Group | Active comparator | Virtual Reality Alone Receives: Other: Virtual Reality Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl Meyer Assessment Scale - Lower Extremity
This scale is recognized as a golden standard for assessment of motor function of stroke patients worldwide. It focuses on reflex activity, voluntary movements within and outside of synergies, ability to perform isolated movement, and coordination. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible scale score is 226 Motor score: ranges from 0 (hemiplegia) to 100 points (normal motor performance). Divided into 66 points for upper extremity and 34 points for the lower extremity. Sensation: ranges from 0 to 24 points. Balance: ranges from 0 to 14 points. Joint range of motion: ranges from 0 to 44 points. Joint pain: ranges from 0 to 44 points.
Measured: 6 weeks
Berg Balance Scale
changes from the baseline, Berg balance scale is used for assessment of balance and fall risk, Higher scores on the berg balance scale indicate greater independence and better ability to balance. In contrast, lower scores indicate a greater fall risk Items DESCRIPTION SCORE (0-4) Sitting to standing, Standing unsupported, Sitting unsupported, Standing to sitting, Transfers , Standing with eyes closed , Standing with feet together, Reaching forward with outstretched arm, Retrieving object from floor, Turning to look behind, Turning 360 degrees, Placing alternate foot on stool, Standing with one foot in front, Standing on one foot, TOTAL __/56
Measured: 6 weeks
Timed Up and Go test
changes from the baseline, Timed up and go test is used for the assessment of falls risk among the elderly population. The Timed "Up and Go" (TUG) Test measures, in seconds, the time is taken by an individual to stand up from a standard armchair (approximate seat height of 46 cm, arm height 65 cm), walk a distance of 3 meters (approximately 10 feet), turn, walk back to the chair, and sit down. Normal healthy elderly usually complete the task in 10 seconds or less. Very frail or weak elderly with poor mobility may take 2 minutes or more. Clinical guide: <10 seconds = normal <20 seconds = good mobility, can go out alone, mobile without a gait aid <30 seconds = problems, cannot go outside alone, requires a gait aid A score of more than or equal to 14 seconds has been shown to indicate a high risk of falls.
Measured: 6 weeks
10-meter walk test
In this test, the participant walks through a 10-m walkway without any break. At the 4-m of walkway, time is recorded in order to obtain a rhythmic phase of walking speed. Then the time required over 3 trials was converted to the walking speed. The reliability of 10-m walk test is 0.83 and literature also shows the construct validity of 10-meter walk test.
Measured: 6 weeks
Wisconsin Gait Scale
This scale is used to assess gait cycle. It consists of 14 items, the higher the score, greater will be the disability. These scale focuses on the components of stance phase, guardedness of affected leg, toe off, swing phase and heel strike. The reliability of Wisconsin Gait Scale was 0.91 and 0.96 and Cronbach scores were 0.91 and 0.94 respectively. Minimum score is 13.35 \& maximum score is 42. The higher the score the more seriously affected the gait.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start27 Apr 2022
- Primary completion5 Feb 2023
- Study completion5 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arshad Nawaz Malik, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05338918
- Sponsor's protocol ID
- 01261/Tasmiyah Asghar
- Status last verified
- Feb 2023
- First submitted
- 15 Apr 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mental Imagery With Virtual Reality Training on Lower Limb Functions in Stroke
- ClinicalTrials.gov ID
- NCT05338918
- Acronym / sponsor ID
- 01261/Tasmiyah Asghar
- Conditions
- Stroke
- Keywords
- Lower limb, Impairment, Mental practice, Virtual Reality training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- 5 Feb 2023 (actual)
- Study completion
- 5 Feb 2023 (actual)
- First posted
- 21 Apr 2022 (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.
This study aims to compare the effects of mental imagery and virtual reality training with virtual reality alone on lower limb functional status of stroke patients. The study will be a randomized controlled trial. After the initial evaluation randomization will be done on participants lying under the eligibility criteria. Randomized participants will be allocated to Control \& Experimental groups. Mental imagery (Audiotape recordings of some specific tasks for lower limb functions) with Virtual reality training given to experimental group while Virtual reality training alone to Control group. Task oriented training for balance \& gait as baseline treatment will be given to each group.
Detailed description
Stroke causes inability to perform activities with affected limbs among which difficulty in walking and doing house chores are the most common dysfunctions. Stroke highly affects the productivity of people in family as well as in community. It also adds financial burden on families of patients. There are number of different restorative techniques and therapeutic approaches for the rehabilitation of stroke patients. For example, bobath approach, constrained induced movement therapy, mirror therapy, electrical stimulations, Circuit training, resistance training, Motor relearning program, proprioceptive neuromuscular facilitation, body weight supported treadmill for walking, Frenkel's exercises, repetitive task specific training, electromyography biofeedback and many others. All these approaches mainly focused on the repetition of tasks to perform a specific function, as the neuroplasticity requires repetition to occur. But there is a lack of interest, motivation and attention of stroke patients to perform similar tasks repeatedly. The lack of active participation directly or indirectly affects the neural stimulation and neural plasticity. One of the most emerging techniques in these days is Mental Imagery. Mental imagery(MI) is "a training method where imagination of movements, without actually moving, is used with the intention of improving motor performance" Currently Mental imagery has been used for neuro rehabilitation as it activates the same brain areas required for planning and execution of movements more or less in the same way require for actual performance of that movement. In this study the combination for Mental imagery and virtual reality is used for participation of patients in rehabilitation program which in turn increases the neural stimulation and causes neural plasticity to improve the motor performance. By increasing the functional activity, their ADL's can be improved to help them in becoming the active member of the society.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mental Imagery with Virtual Reality Group | Experimental | Other: Mental Imagery with Virtual Reality TrainingMental Imagery with Virtual Reality |
| Virtual Reality Alone Group | Active comparator | Other: Virtual Reality TrainingVirtual Reality Alone |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with sub-acute/ chronic stroke (>3 months)
- Modified Ashworth Ranking Scale 1-3
- Montreal Cognitive Assessment scoring >24-30
Key exclusion criteria (5 listed)
- Any active pathological condition
- Visual or hearing impairment
- Neurological conditions like Epilepsy, Parkinson, Alzheimer's, Impaired cognition
- Orthopedic issues hindering Mobility Substantially (Fractures, Severe Degenerative Joint Diseases etc.)
- Psychological issues
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 |
|---|---|---|
| Mental Imagery with Virtual Reality TrainingMental Imagery TASK Practice with Virtual Reality Training: 30-40 minutes treatment sessions will be performed three times a week for six weeks, Part 1: 2-3 minutes of relaxation Part 2: Visual Imagery (external motor imagery training) for 5-8 minutes Part 3: Actual Task Practice for 10 minutes Part 4: Virtual Reality based training (including games for lower limb functions) for 10 minutes Part 5:Task Oriented training for 10 minutes Tasks for both (mental imagery + actual task practice) will be: Sit-stand task, Static stance (30 seconds), Indoor walk on a leveled surface, Walk indoor towards target, Forward / Side Stepping, Walking outdoors | Other | Mental Imagery with Virtual Reality Group |
| Virtual Reality TrainingVirtual Reality Training: 30-40 minutes treatment sessions will be performed three times a week for six weeks. Games will include River rush, 20000 water leaks, reflex ridge along with task oriented training. Tasks will be: Sit-stand task, Static stance (30 seconds), Indoor walk on a leveled surface, Walk indoor towards target, Forward / Side Stepping, Walking outdoors | Other | Virtual Reality Alone Group |
Primary outcome
Fugl Meyer Assessment Scale - Lower Extremity
Time frame: 6 weeks
This scale is recognized as a golden standard for assessment of motor function of stroke patients worldwide. It focuses on reflex activity, voluntary movements within and outside of synergies, ability to perform isolated movement, and coordination. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible scale score is 226 Motor score: ranges from 0 (hemiplegia) to 100 points (normal motor performance). Divided into 66 points for upper extremity and 34 points for the lower extremity. Sensation: ranges from 0 to 24 points. Balance: ranges from 0 to 14 points. Joint range of motion: ranges from 0 to 44 points. Joint pain: ranges from 0 to 44 points.
Berg Balance Scale
Time frame: 6 weeks
changes from the baseline, Berg balance scale is used for assessment of balance and fall risk, Higher scores on the berg balance scale indicate greater independence and better ability to balance. In contrast, lower scores indicate a greater fall risk Items DESCRIPTION SCORE (0-4) Sitting to standing, Standing unsupported, Sitting unsupported, Standing to sitting, Transfers , Standing with eyes closed , Standing with feet together, Reaching forward with outstretched arm, Retrieving object from floor, Turning to look behind, Turning 360 degrees, Placing alternate foot on stool, Standing with one foot in front, Standing on one foot, TOTAL __/56
Timed Up and Go test
Time frame: 6 weeks
changes from the baseline, Timed up and go test is used for the assessment of falls risk among the elderly population. The Timed "Up and Go" (TUG) Test measures, in seconds, the time is taken by an individual to stand up from a standard armchair (approximate seat height of 46 cm, arm height 65 cm), walk a distance of 3 meters (approximately 10 feet), turn, walk back to the chair, and sit down. Normal healthy elderly usually complete the task in 10 seconds or less. Very frail or weak elderly with poor mobility may take 2 minutes or more. Clinical guide: <10 seconds = normal <20 seconds = good mobility, can go out alone, mobile without a gait aid <30 seconds = problems, cannot go outside alone, requires a gait aid A score of more than or equal to 14 seconds has been shown to indicate a high risk of falls.
10-meter walk test
Time frame: 6 weeks
In this test, the participant walks through a 10-m walkway without any break. At the 4-m of walkway, time is recorded in order to obtain a rhythmic phase of walking speed. Then the time required over 3 trials was converted to the walking speed. The reliability of 10-m walk test is 0.83 and literature also shows the construct validity of 10-meter walk test.
Wisconsin Gait Scale
Time frame: 6 weeks
This scale is used to assess gait cycle. It consists of 14 items, the higher the score, greater will be the disability. These scale focuses on the components of stance phase, guardedness of affected leg, toe off, swing phase and heel strike. The reliability of Wisconsin Gait Scale was 0.91 and 0.96 and Cronbach scores were 0.91 and 0.94 respectively. Minimum score is 13.35 \& maximum score is 42. The higher the score the more seriously affected the gait.
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 21 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
Arshad Nawaz Malik, PhD principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental Imagery with Virtual Reality Training and Virtual Reality 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 3 inclusion and 5 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 21 Feb 2023. 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?
Fugl Meyer Assessment Scale - Lower Extremity (time frame: 6 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2023.