StrokeNCT05812638
Mental Imagery for Lower Limb Functions
A study testing Mental imagery technique and Virtual Reality technique in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
Stroke is a neurological impairment occurs due to cardiovascular abnormality and cerebrovascular disease. The term 'stroke' is mostly used when there is sudden loss of function of the body due any abrupt changes.The rates of disability are increasing along with mortality and morbidity rates due to stroke. 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 technique and Virtual Reality technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2023to 30 Sep 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
- Stroke patients (both genders)
- Age 40-60 years
- Patients with sub-acute/ chronic stroke (>3 months)
- Modified Ashworth Ranking Scale 1-3
- MOCA scoring >24-30
Who cannot join
- Any active pathological condition
- Visual or hearing impairment
- Orthopedic issues hindering Mobility Substantially (Fractures, Severe Degenerative
- Joint Diseases etc.)
- Psychological issues
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Railway General Hospital
Rawalpindi
Tasmiya Asghar, DPT
About this study
Official title: Effects of Mental Imagery With Virtual Reality Training on Lower Limb Functions in Stroke
Stroke is a neurological impairment occurs due to cardiovascular abnormality and cerebrovascular disease. The term 'stroke' is mostly used when there is sudden loss of function of the body due any abrupt changes.The rates of disability are increasing along with mortality and morbidity rates due to stroke. The poor motor performance of lower limb affects gait severely. The slow velocity and other gait deviations limit the stroke survivors' ability to perform ADL's and interfere with their quality of life.
Hence, rehabilitation is obligatory for these patients to improve their quality of life
Read the detailed description
motor imagery is helpful in improving mobility in healthy and neurologically impaired patients. When the patient is asked to do a movement, for example the patient is asked to walk along a draw line and then that patient has to imagine this same action in kinesthetic imagery. Neuroimaging shows that brain areas are more or less activated in the same manner. It can be concluded that there is some relation between mental imagery ability and muscular actions. In the stroke patients who have intact ability of mental imagery show activation of cortical areas demonstrating its ability to activate sub cortical areas also. Therefore, these results amplify the concept of using mental imagery for rehabilitation purpose of even deep lesion in motor nervous system.
- Conditions
- Stroke
- Being tested
- Mental imagery technique, Virtual Reality technique
- 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 techniqueOther
Warm up Period Mental Imagery (Sit-stand task Static stance (30 seconds) Indoor walk on a leveled surface Walk indoor towards target Forward / Side Stepping) Walk outdoors
Virtual Reality techniqueOther
Virtual reality training (River rush, 20000 water leaks, reflex ridge.)
| Study group | Role | What they receive |
|---|---|---|
| Mental Imagery | Experimental | For mental imagery, the calm and nice atmosphere isrequired for the patientsto focus on the details while sitting on a chair. The audiotape and headphones are given to the patients. The audiotape tape comprised of three phases. The first phase is relaxation phase. The patient has to do the first phase actively. In this phase patients have asked to do the deep breathing exercises while sitting on a chair and then contract their lower limb muscles from distal to proximal. The second phase is task-oriented phase. The patient has to imagine him performing the tasks. Receives: Other: Mental imagery technique |
| Virtual Reality | Active comparator | The virtual reality training will be given through Kinect connected with Xbox 360.
The Xbox games used are 20,000 water leaks, reflex ridge and river rush. The spacious environment will be given and walker are sometimes required for assistance. The LED and system are 3 feet away from patients. The VR training will be given to the both control and experimental groups Receives: Other: Virtual Reality technique |
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
Measured: week 6
Berg Balance Scale
In elderly Population, BBS is most commonly used outcome measure for functional balance. It is 14 Item balance measure scored on 5-point ordinal scale with range of 0 to 4, where high score indicates good balance \& decreased risk of fall and vice versa.
A maximum score of 56 is achievable
Measured: week 6
Timed Up and Go test
It is used to assess functional mobility; the risk of fall and dynamic balance can also be determined. In TUG test, the participant is asked to get up from a chair, walk a distance of 3 meters at Regular pace, turn around, walk a distance of 3 meter back to the chair and sit down
Measured: week 6
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
Measured: week 6
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
Measured: week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start1 Mar 2023
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
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
- Investigator, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- arshad Malik, Phd, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812638
- Sponsor's protocol ID
- REC/01261 Tasmiya
- Status last verified
- Mar 2023
- First submitted
- 31 Mar 2023
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Apr 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
- NCT05812638
- Acronym / sponsor ID
- REC/01261 Tasmiya
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 13 Apr 2023 (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.
Stroke is a neurological impairment occurs due to cardiovascular abnormality and cerebrovascular disease. The term 'stroke' is mostly used when there is sudden loss of function of the body due any abrupt changes.The rates of disability are increasing along with mortality and morbidity rates due to stroke. The poor motor performance of lower limb affects gait severely. The slow velocity and other gait deviations limit the stroke survivors' ability to perform ADL's and interfere with their quality of life.
Hence, rehabilitation is obligatory for these patients to improve their quality of life
Detailed description
motor imagery is helpful in improving mobility in healthy and neurologically impaired patients. When the patient is asked to do a movement, for example the patient is asked to walk along a draw line and then that patient has to imagine this same action in kinesthetic imagery. Neuroimaging shows that brain areas are more or less activated in the same manner. It can be concluded that there is some relation between mental imagery ability and muscular actions. In the stroke patients who have intact ability of mental imagery show activation of cortical areas demonstrating its ability to activate sub cortical areas also. Therefore, these results amplify the concept of using mental imagery for rehabilitation purpose of even deep lesion in motor nervous system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mental Imagery | Experimental | Other: Mental imagery techniqueFor mental imagery, the calm and nice atmosphere isrequired for the patientsto focus on the details while sitting on a chair. The audiotape and headphones are given to the patients. The audiotape tape comprised of three phases. The first phase is relaxation phase. The patient has to do the first phase actively. In this phase patients have asked to do the deep breathing exercises while sitting on a chair and then contract their lower limb muscles from distal to proximal. The second phase is task-oriented phase. The patient has to imagine him performing the tasks. |
| Virtual Reality | Active comparator | Other: Virtual Reality techniqueThe virtual reality training will be given through Kinect connected with Xbox 360. The Xbox games used are 20,000 water leaks, reflex ridge and river rush. The spacious environment will be given and walker are sometimes required for assistance. The LED and system are 3 feet away from patients. The VR training will be given to the both control and experimental groups |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Stroke patients (both genders)
- Age 40-60 years
- Patients with sub-acute/ chronic stroke (>3 months)
- Modified Ashworth Ranking Scale 1-3
- MOCA scoring >24-30
Key exclusion criteria (5 listed)
- Any active pathological condition
- Visual or hearing impairment
- 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 techniqueWarm up Period Mental Imagery (Sit-stand task Static stance (30 seconds) Indoor walk on a leveled surface Walk indoor towards target Forward / Side Stepping) Walk outdoors | Other | Mental Imagery |
| Virtual Reality techniqueVirtual reality training (River rush, 20000 water leaks, reflex ridge.) | Other | Virtual Reality |
Primary outcome
Fugl Meyer Assessment Scale - Lower Extremity
Time frame: week 6
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
Berg Balance Scale
Time frame: week 6
In elderly Population, BBS is most commonly used outcome measure for functional balance. It is 14 Item balance measure scored on 5-point ordinal scale with range of 0 to 4, where high score indicates good balance \& decreased risk of fall and vice versa. A maximum score of 56 is achievable
Timed Up and Go test
Time frame: week 6
It is used to assess functional mobility; the risk of fall and dynamic balance can also be determined. In TUG test, the participant is asked to get up from a chair, walk a distance of 3 meters at Regular pace, turn around, walk a distance of 3 meter back to the chair and sit down
10-meter walk test
Time frame: week 6
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
Wisconsin Gait Scale
Time frame: week 6
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- 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.
arshad 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 technique and Virtual Reality technique 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 5 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: status not confirmed, as of the sponsor's last update on 13 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arshad Malik, PhD (+92 333 4503754, arshad.nawaz@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl Meyer Assessment Scale - Lower Extremity (time frame: week 6). 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 13 Apr 2023.