Effects of Cognitive Exercises With Sensory Motor Relearning Program on Upper Limb Function in Sub-Acute Stroke Patients

NCT ID: NCT06130891

Last Updated: 2024-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-05
• Study Completion Date: 2024-03-30

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.

Conditions

Stroke; Ischemic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cognitive sensory motor relearning Group

Cognitive, sensory, and motor training

Group Type: EXPERIMENTAL

Cognitive sensory motor relearning

Intervention Type: OTHER

Cognitive Exercises:

• Orientation: Checking awareness of date, time, and weather.
• Attention: Tasks like connecting dots or spotting differences.
• Shape Sorting: Sorting objects by size, color, etc.
• Calculation Training: Counting money, beads, basic arithmetic.
• Memory: Recalling objects on a tray, numbers backward, word associations.

Sensory Relearning:

• Discrimination: Identifying textures, shapes, sizes, and temperatures.
• Tactile Recognition: Recognizing objects through touch.
• Proprioception: Matching affected limb's position to unaffected limb's.

Motor Relearning:

• Task-Specific Training: Grasping, pouring, wiping, screwing, holding objects.
• Progression: Increasing duration, intensity, and resistance. 45 minutes per day, 5 days a week for 6 weeks.

Sensory Motor Relearning Group

Sensory and motor training

Group Type: EXPERIMENTAL

Sensory motor relearning

Intervention Type: OTHER

Sensory Relearning:

• Discrimination: Identifying textures, shapes, sizes, and temperatures.
• Tactile Recognition: Recognizing objects through touch.
• Proprioception: Matching affected limb's position to unaffected limb's.

Motor Relearning:

• Task-Specific Training: Grasping, pouring, wiping, screwing, holding objects.
• Progression: Increasing duration, intensity, and resistance. 45 minutes per day, 5 days a week for 6 weeks.

Motor Relearning Group

Motor training

Group Type: EXPERIMENTAL

Motor Relearning

Intervention Type: OTHER

Motor Relearning:

• Task-Specific Training: Grasping, pouring, wiping, screwing, holding objects.
• Progression: Increasing duration, intensity, and resistance. 45 minutes per day, 5 days a week for 6 weeks.

Interventions

Cognitive sensory motor relearning

Cognitive Exercises:

• Orientation: Checking awareness of date, time, and weather.
• Attention: Tasks like connecting dots or spotting differences.
• Shape Sorting: Sorting objects by size, color, etc.
• Calculation Training: Counting money, beads, basic arithmetic.
• Memory: Recalling objects on a tray, numbers backward, word associations.

Sensory Relearning:

• Discrimination: Identifying textures, shapes, sizes, and temperatures.
• Tactile Recognition: Recognizing objects through touch.
• Proprioception: Matching affected limb's position to unaffected limb's.

Motor Relearning:

• Task-Specific Training: Grasping, pouring, wiping, screwing, holding objects.
• Progression: Increasing duration, intensity, and resistance. 45 minutes per day, 5 days a week for 6 weeks.

Intervention Type: OTHER

Sensory motor relearning

Sensory Relearning:

• Discrimination: Identifying textures, shapes, sizes, and temperatures.
• Tactile Recognition: Recognizing objects through touch.
• Proprioception: Matching affected limb's position to unaffected limb's.

Motor Relearning:

• Task-Specific Training: Grasping, pouring, wiping, screwing, holding objects.
• Progression: Increasing duration, intensity, and resistance. 45 minutes per day, 5 days a week for 6 weeks.

Intervention Type: OTHER

Motor Relearning

Motor Relearning:

• Task-Specific Training: Grasping, pouring, wiping, screwing, holding objects.
• Progression: Increasing duration, intensity, and resistance. 45 minutes per day, 5 days a week for 6 weeks.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aruba Saeed, PhD

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

THQ Hospital, Muridke, Sheikhupura, Punjab

Sheikhupura, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

REC/ 0244 Hifsa Waheed

Identifier Type: -

Identifier Source: org_study_id