HemiplegiaNCT06059781
Effects of Auditory and Visual Cueing on Sensorimotor Recovery and Gait in Hemiplegia
A study testing Rhtyhmical auditory stimulation and Visual cues (Experimental group) in people with Hemiplegia, run by Riphah International University at 1 site in Pakistan.
Trial summary
Stroke is also known as a brain attack, happens when a blood vessel in the brain breaks or when something stops the flow of blood to a specific area of the brain. Parts of the brain undergo damage or die in either case. Stroke victims may experience permanent brain damage, long-term disability or even death. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Hemiplegia
- What is being tested?
- Rhtyhmical auditory stimulation and Visual cues (Experimental group)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2023to 15 Dec 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range between 45-65 years
- Both male and female genders
- Clinically diagnosed of stroke referred by Neuro physician
- Patients in the chronic stage after 6 months of stroke can walk 10 meters independently.
- Patients with anterior cerebral artery (ACA) and middle cerebral artery (MCA) involvement with the affected side being the dominant side
- Those with Brunnstrom's recovery stages 3 and 4 will take part
- Patients with Mini-Mental State Examination (MMS) score greater than 16.
- According to Modified Ashworth Scale, patients of grades 1 and 1+ will be included. Muscles that go into the spasticity include hip adductors, knee flexors and ankle plantar flexors
Who cannot join
- Patients with dementia, depression or productive psychosis will not include.
- Patients having any visual or auditory impairment will be excluded.
- Patients with foot drop
- Recurrent transient ischemic attack (TIA)
- Patients with recurrent stroke
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Tehreem Mukhtar
Lahore, Punjab Province, 54000
Tehreem Mukhtar, PhD, +923134715275, tehreem.mukhtar@riphah.edu.pk
About this study
Official title: Combined Effects of Auditory and Visual Rhythmical Cueing on Lower Limb Sensorimotor Recovery and Gait Parameters in Patients With Hemiplegia
Stroke is also known as a brain attack, happens when a blood vessel in the brain breaks or when something stops the flow of blood to a specific area of the brain. Parts of the brain undergo damage or die in either case. Stroke victims may experience permanent brain damage, long-term disability or even death. The main objective of this study is to evaluate the impact of combined auditory and visual rhythmical cueing on lower limb sensorimotor recovery and gait parameters in patients with hemiplegia. It will be a randomized controlled trial. In this study 28 patients will be recruited through non probability convenience sampling technique. The patients fulfilling inclusion and exclusion criteria will be randomly divided into experimental group (n=14) and control group (n=14) by using computer engendered in blocks by using a basic number generator. Distribution will be concealed by the sealed envelope method. Baseline treatment will be given to both groups.
Baseline treatment includes a range of motion exercises for the lower extremity, passive stretching of tight muscles and conventional march exercises including marching, forward, backward and sideways walking. Conventional training will be given for 15 minutes, 3 sessions per week for 4 weeks. Experimental group (n=14) will be treated with auditory stimulation and visual cues. All participants will undergo the training for 45 minutes per session, 3 days per week for 4 weeks. The control group (n=14) will be treated with auditory stimulation only. All participants will undergo the training for 45 minutes per session, 3 days per week for 4 weeks.
Subjective tool for sensory assessment includes Fugl-Meyer Assessment (FMA) for the lower extremity (LE) tool. For gait, it includes Dynamic Gait Index (DGI) tool. Objective tools will include cadence, gait velocity/walking speed, stride length, step length, step width, stride length symmetry ratio and step length symmetry ratio. Data will be analyzed by using SPSS (Statistical Package for Social Sciences) 23 version.
Read the detailed description
A neurological condition known as a stroke is characterized by blood vessel obstruction. Brain clots prevent blood from flowing properly, obstructing arteries and causing blood vessels to burst, which causes bleeding. The abrupt death of brain cells due to a lack of oxygen occurs when the arteries leading to the brain are ruptured during a stroke . Stroke subtypes can be categorized as ischemic or hemorrhagic depending on the etiology. The majority of stroke cases (80-87%) are ischemic strokes, which can be either focal (caused by thrombosis, cardio-embolism, or atherosclerosis and platelets plugging an artery) or global (caused by a complete reduction in blood flow to the brain during a cardiac arrest). Ischemic stroke can also be lethal or not. On the other side, a blood vessel rupture results in hemorrhagic stroke . During a transient ischemic attack (TIA), arterial supply to brain tissue is temporarily cut off, resulting in focal neurologic symptoms such as hemiparesis, but spontaneous flow restoration leads to symptom relief without long-term tissue damage . Gehan M. Ahmed1, Ebtesam M. Fahmy (2023) did an RCT (randomized control trial) study in which they recruited 30 male stroke patients. Group A (control group) was treated with strengthening exercises for weak upper and lower limb, stretching exercises for lower extremity muscles, weight bearing on affected side and treadmill exercises for 6 weeks. While group B (experimental group) had rhythmical auditory stimulation (RAS) in addition with treadmill training exercise. Results of this study showed that post treatment improvement in gait parameters was significantly higher in the study group compared to the controls.
Xin Li1, Lu Wang (2022) did a controlled study in which they enrolled 24 stroke patients with severe upper limb motor deficits. One group (n=12) was treated with combined conventional training and sensorimotor rhythm-based brain computer interference (SMR-BCI) with an audio cue, motor observation with multisensory feedback for rehabilitation of upper limb. The second group(n=12) was treated with conventional treatment only. Results of this study concluded that the first group which was treated with combined conventional and (SMR-BCI) with auditory cues, motor observation with sensory feedback might promote long lasting upper limb improvement.
- Conditions
- Hemiplegia
- Being tested
- Rhtyhmical auditory stimulation and Visual cues (Experimental group), Rhtyhmical auditory stimulation (Control group)
- Keywords
- auditory, visual, sensorimotor, hemiplegia, gait
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhtyhmical auditory stimulation and Visual cues (Experimental group)Other
For auditory stimulation, walking exercises are performed on a flat floor walking path without rhythmic or musical influence. Rhythmical auditory stimulation (RAS) is produced by using Metronome App on a mobile phone.
For visual stimulation, white chalk will use to draw visual signals on the ground. For gait recovery, a 10-meter walkway will draw on the floor with parallel lines 2.5cm broad and 90cm long. Interline distance will maintain at 110% of the length of the initial step.
Routine recovery treatment includes a range of motion exercises for the lower extremity, passive stretching of tight muscles and conventional march exercises including marching, forward, backward and sideways walking.
Experimental group will be treated for 45 minutes per session, 3 days per week for 6 weeks.
Rhtyhmical auditory stimulation (Control group)Other
For auditory stimulation, walking exercises are performed on a flat floor walking path without rhythmic or musical influence. Rhythmical auditory stimulation (RAS) is produced by using Metronome App on a mobile phone.
Routine recovery treatment includes a range of motion exercises for the lower extremity, passive stretching of tight muscles and conventional march exercises including marching, forward, backward and sideways walking.
Control group will be treated for 45 minutes per session, 3 days per week for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Rhtyhmical auditory stimulation and Visual cues (Experimental group) | Experimental | For auditory stimulation, walking exercises are performed on a flat floor walking path without rhythmic or musical influence. Rhythmical auditory stimulation (RAS) is produced by using Metronome App on a mobile phone.
For visual stimulation, white chalk will use to draw visual signals on the ground. For gait recovery, a 10-meter walkway will draw on the floor with parallel lines 2.5cm broad and 90cm long. Interline distance will maintain at 110% of the length of the initial step.
Routine rehablitation treatment includes a range of motion exercises for the lower extremity, passive stretching of tight muscles and conventional march exercises including marching, forward, backward and sideways walking.
Experimental group will be treated for 45 minutes per session, 3 days per week for 6 weeks. Receives: Other: Rhtyhmical auditory stimulation and Visual cues (Experimental group) |
| Rhtyhmical auditory stimulation (control group) | Other | For auditory stimulation, walking exercises are performed on a flat floor walking path without rhythmic or musical influence. Rhythmical auditory stimulation (RAS) is produced by using Metronome App on a mobile phone.
Routine rehablitation treatment includes a range of motion exercises for the lower extremity, passive stretching of tight muscles and conventional march exercises including marching, forward, backward and sideways walking.
Control group will be treated for 45 minutes per session, 3 days per week for 6 weeks. Receives: Other: Rhtyhmical auditory stimulation (Control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment FMA (LE)
FMA is used to assess sensorimotor function which consists of maximum 28 points for lower extremity and 6 points for speed and coordination. The total summed score of 34 points indicates normal function. Higher the score more is the independence.
Measured: Changes from baseline Fugl-Meyer Assessment FMA (LE) at 3rd week and after 6 weeks
Dynamic Gait Index (DGI)
DGI is composed of a total of 8 items. Total score is 24. In total, a score of less than 19/24 is predictive of falls in the elderly. A score of >22 signifies a safe ambulator.
Measured: Changes from baseline Dynamic Gait Index (DGI) at 3rd week and after 6 weeks
Cadence
Number of steps taken per unit time
Measured: Changes from baseline Cadence at 3rd week and after 6 weeks
Gait velocity/Walking speed
10 min walk test
Measured: Changes from baseline Gait velocity/Walking speed at 3rd week and after 6 weeks
Stride length
Distance between successive ground contacts of the same foot by using measuring tape.
Measured: Changes from baseline Stride length at 3rd week and after 6 weeks
Step length
Distance between successive ground contact of the opposite foot by using measuring tape.
Measured: Changes from baseline Step length at 3rd week and after 6 weeks
Step width
Transverse linear distance between two successive feet from the centers of heels by using measuring tape.
Measured: Changes from baseline Step width at 3rd week and after 6 weeks
Step length symmetry ratio
It will be calculated by dividing step length of paretic limb to non-paretic limb.
Measured: Changes from baseline Step length symmetry ratio at 3rd week and after 6 weeks
Stride length symmetry ratio
It will be calculated by dividing the stride length of paretic limb to non-paretic limb.
Measured: Changes from baseline Stride length symmetry ratio at 3rd week and after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start1 Sep 2023
- Primary completion1 Dec 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sehrish Naureen, MSPT-NM, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059781
- Sponsor's protocol ID
- RiphahIU Sehrish Naureen
- Status last verified
- Sep 2023
- First submitted
- 22 Sep 2023
- Last updated
- 29 Sep 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 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Auditory and Visual Rhythmical Cueing on Lower Limb Sensorimotor Recovery and Gait Parameters in Patients With Hemiplegia
- ClinicalTrials.gov ID
- NCT06059781
- Acronym / sponsor ID
- RiphahIU Sehrish Naureen
- Conditions
- Hemiplegia
- Keywords
- auditory, visual, sensorimotor, hemiplegia, gait
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 29 Sep 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 also known as a brain attack, happens when a blood vessel in the brain breaks or when something stops the flow of blood to a specific area of the brain. Parts of the brain undergo damage or die in either case. Stroke victims may experience permanent brain damage, long-term disability or even death. The main objective of this study is to evaluate the impact of combined auditory and visual rhythmical cueing on lower limb sensorimotor recovery and gait parameters in patients with hemiplegia. It will be a randomized controlled trial. In this study 28 patients will be recruited through non probability convenience sampling technique. The patients fulfilling inclusion and exclusion criteria will be randomly divided into experimental group (n=14) and control group (n=14) by using computer engendered in blocks by using a basic number generator. Distribution will be concealed by the sealed envelope method. Baseline treatment will be given to both groups.
Baseline treatment includes a range of motion exercises for the lower extremity, passive stretching of tight muscles and conventional march exercises including marching, forward, backward and sideways walking. Conventional training will be given for 15 minutes, 3 sessions per week for 4 weeks. Experimental group (n=14) will be treated with auditory stimulation and visual cues. All participants will undergo the training for 45 minutes per session, 3 days per week for 4 weeks. The control group (n=14) will be treated with auditory stimulation only. All participants will undergo the training for 45 minutes per session, 3 days per week for 4 weeks.
Subjective tool for sensory assessment includes Fugl-Meyer Assessment (FMA) for the lower extremity (LE) tool. For gait, it includes Dynamic Gait Index (DGI) tool. Objective tools will include cadence, gait velocity/walking speed, stride length, step length, step width, stride length symmetry ratio and step length symmetry ratio. Data will be analyzed by using SPSS (Statistical Package for Social Sciences) 23 version.
Detailed description
A neurological condition known as a stroke is characterized by blood vessel obstruction. Brain clots prevent blood from flowing properly, obstructing arteries and causing blood vessels to burst, which causes bleeding. The abrupt death of brain cells due to a lack of oxygen occurs when the arteries leading to the brain are ruptured during a stroke . Stroke subtypes can be categorized as ischemic or hemorrhagic depending on the etiology. The majority of stroke cases (80-87%) are ischemic strokes, which can be either focal (caused by thrombosis, cardio-embolism, or atherosclerosis and platelets plugging an artery) or global (caused by a complete reduction in blood flow to the brain during a cardiac arrest). Ischemic stroke can also be lethal or not. On the other side, a blood vessel rupture results in hemorrhagic stroke . During a transient ischemic attack (TIA), arterial supply to brain tissue is temporarily cut off, resulting in focal neurologic symptoms such as hemiparesis, but spontaneous flow restoration leads to symptom relief without long-term tissue damage . Gehan M. Ahmed1, Ebtesam M. Fahmy (2023) did an RCT (randomized control trial) study in which they recruited 30 male stroke patients. Group A (control group) was treated with strengthening exercises for weak upper and lower limb, stretching exercises for lower extremity muscles, weight bearing on affected side and treadmill exercises for 6 weeks. While group B (experimental group) had rhythmical auditory stimulation (RAS) in addition with treadmill training exercise. Results of this study showed that post treatment improvement in gait parameters was significantly higher in the study group compared to the controls.
Xin Li1, Lu Wang (2022) did a controlled study in which they enrolled 24 stroke patients with severe upper limb motor deficits. One group (n=12) was treated with combined conventional training and sensorimotor rhythm-based brain computer interference (SMR-BCI) with an audio cue, motor observation with multisensory feedback for rehabilitation of upper limb. The second group(n=12) was treated with conventional treatment only. Results of this study concluded that the first group which was treated with combined conventional and (SMR-BCI) with auditory cues, motor observation with sensory feedback might promote long lasting upper limb improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rhtyhmical auditory stimulation and Visual cues (Experimental group) | Experimental | Other: Rhtyhmical auditory stimulation and Visual cues (Experimental group)For auditory stimulation, walking exercises are performed on a flat floor walking path without rhythmic or musical influence. Rhythmical auditory stimulation (RAS) is produced by using Metronome App on a mobile phone. For visual stimulation, white chalk will use to draw visual signals on the ground. For gait recovery, a 10-meter walkway will draw on the floor with parallel lines 2.5cm broad and 90cm long. Interline distance will maintain at 110% of the length of the initial step. Routine rehablitation treatment includes a range of motion exercises for the lower extremity, passive stretching of tight muscles and conventional march exercises including marching, forward, backward and sideways walking. Experimental group will be treated for 45 minutes per session, 3 days per week for 6 weeks. |
| Rhtyhmical auditory stimulation (control group) | Other | Other: Rhtyhmical auditory stimulation (Control group)For auditory stimulation, walking exercises are performed on a flat floor walking path without rhythmic or musical influence. Rhythmical auditory stimulation (RAS) is produced by using Metronome App on a mobile phone. Routine rehablitation treatment includes a range of motion exercises for the lower extremity, passive stretching of tight muscles and conventional march exercises including marching, forward, backward and sideways walking. Control group will be treated for 45 minutes per session, 3 days per week for 6 weeks. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age range between 45-65 years
Key exclusion criteria (5 listed)
- Patients with dementia, depression or productive psychosis will not include.
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 |
|---|---|---|
| Rhtyhmical auditory stimulation and Visual cues (Experimental group)For auditory stimulation, walking exercises are performed on a flat floor walking path without rhythmic or musical influence. Rhythmical auditory stimulation (RAS) is produced by using Metronome App on a mobile phone. For visual stimulation, white chalk will use to draw visual signals on the ground. For gait recovery, a 10-meter walkway will draw on the floor with parallel lines 2.5cm broad and 90cm long. Interline distance will maintain at 110% of the length of the initial step. Routine recovery treatment includes a range of motion exercises for the lower extremity, passive stretching of tight muscles and conventional march exercises including marching, forward, backward and sideways walking. Experimental group will be treated for 45 minutes per session, 3 days per week for 6 weeks. | Other | Rhtyhmical auditory stimulation and Visual cues (Experimental group) |
| Rhtyhmical auditory stimulation (Control group)For auditory stimulation, walking exercises are performed on a flat floor walking path without rhythmic or musical influence. Rhythmical auditory stimulation (RAS) is produced by using Metronome App on a mobile phone. Routine recovery treatment includes a range of motion exercises for the lower extremity, passive stretching of tight muscles and conventional march exercises including marching, forward, backward and sideways walking. Control group will be treated for 45 minutes per session, 3 days per week for 6 weeks. | Other | Rhtyhmical auditory stimulation (control group) |
Primary outcome
Fugl-Meyer Assessment FMA (LE)
Time frame: Changes from baseline Fugl-Meyer Assessment FMA (LE) at 3rd week and after 6 weeks
FMA is used to assess sensorimotor function which consists of maximum 28 points for lower extremity and 6 points for speed and coordination. The total summed score of 34 points indicates normal function. Higher the score more is the independence.
Dynamic Gait Index (DGI)
Time frame: Changes from baseline Dynamic Gait Index (DGI) at 3rd week and after 6 weeks
DGI is composed of a total of 8 items. Total score is 24. In total, a score of less than 19/24 is predictive of falls in the elderly. A score of >22 signifies a safe ambulator.
Cadence
Time frame: Changes from baseline Cadence at 3rd week and after 6 weeks
Number of steps taken per unit time
Gait velocity/Walking speed
Time frame: Changes from baseline Gait velocity/Walking speed at 3rd week and after 6 weeks
10 min walk test
Stride length
Time frame: Changes from baseline Stride length at 3rd week and after 6 weeks
Distance between successive ground contacts of the same foot by using measuring tape.
Step length
Time frame: Changes from baseline Step length at 3rd week and after 6 weeks
Distance between successive ground contact of the opposite foot by using measuring tape.
Step width
Time frame: Changes from baseline Step width at 3rd week and after 6 weeks
Transverse linear distance between two successive feet from the centers of heels by using measuring tape.
Step length symmetry ratio
Time frame: Changes from baseline Step length symmetry ratio at 3rd week and after 6 weeks
It will be calculated by dividing step length of paretic limb to non-paretic limb.
Stride length symmetry ratio
Time frame: Changes from baseline Stride length symmetry ratio at 3rd week and after 6 weeks
It will be calculated by dividing the stride length of paretic limb to non-paretic limb.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 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.
Sehrish Naureen, MSPT-NM 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 Rhtyhmical auditory stimulation and Visual cues (Experimental group) in people with Hemiplegia, 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 8 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 29 Sep 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 Tehreem Mukhtar, PhD* (+923134715275, tehreem.mukhtar@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 FMA (LE) (time frame: Changes from baseline Fugl-Meyer Assessment FMA (LE) at 3rd week and after 6 weeks). The study lists 9 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 29 Sep 2023.