Clinical trial NCT04807426: Multisensory Stimulation Exercises And Task Oriented Exercises On Upper Limb Function In Post Stroke Patients.
Official title: Combine Effects Of Multisensory Stimulation Exercises And Task Oriented Exercises On Upper Limb Function In Post Stroke Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
Multisensory stimulation exercises
Task oriented exercises
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-03-19
Enrollment: 32
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study was to determine the effects of Multisensory stimulation exercises and Task-oriented exercises on upper limb function and to determine the effects of Multisensory stimulation exercises and Task-oriented exercises on Activities of daily living and cognition . Study Design was Randomized control trial. Sampling Technique was purposive sampling. Study Setting was Physiotherapy department of Railway General Hospital Rawalpindi and NIRM Islamabad. Inclusion criteria were patients with hemiplegia due to stroke, Both male \& female, Sub-acute and chronic stroke patients, First-ever stroke patient, Age between 40 -65, Modified Ashworth scale \<3.

Exclusion criteria were Un bearable upper limb pain, Recent surgery, Visual impairment and Non cooperative Patients.

Total sample size calculated, by using epi tool is 12. Assessment tools used were Fugal Meyer motor assessment scale, Wolf motor function test, Revised Nottingham sensory, Motor activity log and Montreal cognitive assessment.

Individuals who met the inclusion criteria will be included in this study. All participants will go through randomization and divided into two groups Experimental group 1 and Experimental group 2. The pre-intervention assessment was made for both groups. Then intervention was applied to both groups.All statistical analyses will be performed through SPSS 21.

Detailed description: Stroke is defined as a neurological dysfunction due to sudden or acute injury to the central nervous system due to vascular causes, which includes cerebral infarction, intracranial hemorrhage and subarachnoid hemorrhage.Stroke is categorized as ischemic stroke (85%) and hemorrhage stroke (20%). Hemorrhagic stroke is further classified as interacerebral hemorrhage (15%) and subarachnoid hemorrhage (5%). Transient Ischemic attack (TIA) is a temporary blockage of blood flow to the brain and its symptoms resolves within 24 hours of the injury. Stroke is currently the second leading cause of death worldwide and is one of the leading causes of long-term disability in the United States. Almost 15 million stroke cases occur each year worldwide, resulting in 5 million deaths and leaving about 5 million stroke survivors with unchangeable abnormality and dependency.According to world health organization (WHO) in 2002 approximately 5.5 million people died due to stroke and 20% of these deaths occurred in south Asia .In Pakistan stroke cases reported are estimated to be 3,50,000 annually.Stroke survivors experience damaged upper limb function which also affects their activites of daily living. A large number of them is left with impaired upper extremity function, even after completion of conventional rehabilitation programmes.Only 5-20 % of patients regain Upper extremity functional status.Along with motor impairments somatosensory impairments are also assosoiated with severity of stroke but is overlooked most of the times. Sensory impairment decreases the ability to discriminate textures, weights ,shapes and sizes.Proprioception and stereognosis were found to be more impaired than tatile sensation ,7-53 % had impaired tactile sensations ,31-89% impaied sterognosis and 34-64 % impaired proprioception.Mostly, the focus is on motor recovery in paretic limb but the studies showed that improvement in sensory functions also leads to motor recovery. By only focusing on motor performance without sensory dysfunction assessment, maximum outcomes cannot be achieved.Not only Sensory dysfunction but Cognitive issues after stroke such as ,decreased perception and attention ,memory deficits ,difficulty in problem solving tend to be disregarded which eventually effects patient performance of daily activities.Multisensory stimulation exercises also known as neurocognitive therapeutic exercises, cognitive exercise therapy or cognitive sensory motor training was proposed by Carlo Perfetti of Italy .The Hallmark of this training is that it focuses on sensory retraining along with emphasis on joint position perception. It considers recovery as a learning process, the movement as a means to know and the body as a surface receptor for information.Laia Salles et.al conducted a randomized controlled pilot study to compare the effectiveness of the cognitive exercise therapy with conventional treatment protocol on upper limb in sub-acute stroke patients. The result showed favourable clinical progression regarding upper extremity functional gain.Sunghee Lee et.al did a study on effect of the cognitive exercise therapy on chronic stroke patients upper limb function, activities of daily living and quality of life .They compared it with Task oriented exercise group. There was significant difference between two groups and application of cognitive exercise therapy was found more effective for functional recovery in stroke patients.A study compared the effectiveness of cognitive sensory motor training therapy with conventional therapy on recovery of arm function in acute stroke patients. There were no significant differences found between two groups in acute stroke patients. The studies based on Multisensory stimulation exercises of perfetti focused on evaluating motor function of upper limb ,activities of daily living and quality of life but cognitive elements such as attention and memory also activated in discriminatory tasks and were not evaluated. The past records shows that in randomized controlled trials Multi sensory stimulation therapy is used alone for the experimental group .Combination of two protocols has not been analyzed yet .So, the aim of the study is to observe and determine the combine effect of Task Oriented Exercises and Multisensory stimulation exercises on upper limb function , Activities of daily living and Cognition .It is expected that the combination of these two approaches will give more significant results in improving sub-acute and chronic stroke patients condition.

Eligibility criteria: Inclusion Criteria:

* Patients with hemiplegia due to stroke
* Sub-acute and chronic stroke patients
* First-ever stroke patient
* Modified Ashworth scale \<3

Exclusion criteria:

* Patient that is not well oriented to understand the command to follow the designed motor task
* Un bearable upper limb pain
* Patient with any type of surgical intervention which may hinder assessment and treatment.
* Patients with any other neurological disease
* Non cooperative Patients

Primary outcomes:
measure: Fugal Meyer assessment scale
timeFrame: 4weeks
Secondary outcomes:
Other outcomes:
measure: Wolf Motor Function Test
timeFrame: 4 weeks
measure: Reversed Nottingum Sensory Assessment scale
timeFrame: 4 weeks
measure: Motor Activity log
timeFrame: 4 weeks
measure: Montreal cognitive assesment :
timeFrame: 4 weeks
Locations:
city: Islamabad
country: Pakistan
facility: Riphah International University
Study officials:
affiliation: Riphah International University
name: Dr Aruba Saeed, PHD*
role: PRINCIPAL_INVESTIGATOR
References:
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