Clinical trial NCT06059781: Effects of Auditory and Visual Cueing on Sensorimotor Recovery and Gait in Hemiplegia
Official title: Combined Effects of Auditory and Visual Rhythmical Cueing on Lower Limb Sensorimotor Recovery and Gait Parameters in Patients With Hemiplegia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemiplegia
Keywords: auditory, visual, sensorimotor, hemiplegia, gait
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 28
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Fugl-Meyer Assessment FMA (LE)
timeFrame: Changes from baseline Fugl-Meyer Assessment FMA (LE) at 3rd week and after 6 weeks
measure: Dynamic Gait Index (DGI)
timeFrame: Changes from baseline Dynamic Gait Index (DGI) at 3rd week and after 6 weeks
measure: Cadence
timeFrame: Changes from baseline Cadence at 3rd week and after 6 weeks
measure: Gait velocity/Walking speed
timeFrame: Changes from baseline Gait velocity/Walking speed at 3rd week and after 6 weeks
measure: Stride length
timeFrame: Changes from baseline Stride length at 3rd week and after 6 weeks
measure: Step length
timeFrame: Changes from baseline Step length at 3rd week and after 6 weeks
measure: Step width
timeFrame: Changes from baseline Step width at 3rd week and after 6 weeks
measure: Step length symmetry ratio
timeFrame: Changes from baseline Step length symmetry ratio at 3rd week and after 6 weeks
measure: Stride length symmetry ratio
timeFrame: Changes from baseline Stride length symmetry ratio at 3rd week and after 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Tehreem Mukhtar
state: Punjab
Study officials:
affiliation: Riphah International University
name: Sehrish Naureen, MSPT-NM
role: PRINCIPAL_INVESTIGATOR
References: