Clinical trial NCT06130891: Effects of Cognitive Exercises With Sensory Motor Relearning Program on Upper Limb Function in Sub-Acute Stroke Patients
Official title: Effects of Cognitive Exercises With Sensory Motor Relearning Program on Upper Limb Function in Sub-Acute Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Ischemic
Keywords: cognitive exercise therapy
sensory motor relearning
upper limb function
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-11-14
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare the effects of cognitive sensory motor relearning, and sensory-motor relearning program alone on manual ability, sensation, gross and fine movements, and cognition in post-stroke patients. The main aim is to evaluate the effectiveness of an integrated approach and its impact on motor function, sensory processing, and cognitive skills in sub-acute stroke patients, with the goal of contributing to the development of more efficient rehabilitation interventions for UL sensory-motor impairments after stroke.

Detailed description: Stroke is not only associated with a high mortality rate, but It also leads to major disabilities. The American Heart Association reported that nearly 75% of stroke victims have dysfunction and 15-30% of stroke survivors have severe disability. Stroke survivors often suffer from impaired motor function, sensory processing, and cognitive abilities depending on the severity and site of the lesion, severely impacting their functional independence and quality of life. About 80% of stroke survivors experience some degree of impairment in their UL which includes loss of dexterity, abnormal muscle tone, loss of coordinated movements, and diminished sensations depending upon to nature of the lesion.

Cognitive exercise treatment is a motor learning model that focuses on high-level cognitive function and occurs through the integration of perception-cognition-activity processes, such as motor regulation. Activation of the brain's cognitive process, which includes perception, memory, attention, language, and decision-making, is the core of cognitive training. Most studies have focused on either sensory, motor, or cognitive interventions separately, overlooking the potential benefits of simultaneously addressing these domains. This combined intervention targets not only motor skills, but also cognitive skills, sensory processing, and manual dexterity. By addressing physical and cognitive domains simultaneously, this study aims to evaluate the effectiveness of an integrated approach and its impact on motor function, sensory processing, and cognitive skills in sub-acute ischemic stroke patients, with the goal of contributing to the development of more efficient rehabilitation interventions for UL sensory-motor impairments after stroke.

Eligibility criteria: Inclusion Criteria:

* Both male and female patients.
* 45- 60 years of age.
* 1st ever stroke.
* Sub-acute ischemic stroke.
* 8-12 weeks post stroke patients.
* Participants must have motor and somatosensory deficits in the upper limb on the affected side, as indicated by an ARAT score between 40 and 50 out of 57.
* Participants must be able to provide informed consent or have a legal representative who can provide informed consent on their behalf.
* MoCA score between 18-24
* Modified Ashworth scale \< +1

Exclusion Criteria:

* Participants who have a history of significant neurological or psychiatric disorders, other than stroke, that could interfere with upper limb motor or sensory recovery.
* Participants who have other medical conditions that could interfere with therapy or assessments, such as severe arthritis or joint injuries.
* Participants who have severe visual or hearing impairments that would interfere with therapy or assessments.
* Participants who are currently participating in another clinical trial or research study.

Primary outcomes:
measure: Action Research Arm Test
timeFrame: 6 weeks
measure: Revised Nottingham Sensory Assessment (Somatosensory Impairments)
timeFrame: 6 weeks
measure: ABILHAND questionnaire (ABIL)
timeFrame: 6 weeks
measure: MoCA (Montreal Cognitive Assessment)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sheikhupura
country: Pakistan
facility: THQ Hospital, Muridke, Sheikhupura, Punjab
state: Punjab
Study officials:
affiliation: Riphah International University
name: Aruba Saeed, PhD
role: PRINCIPAL_INVESTIGATOR
References: