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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Ischemic
• Intervention / Treatment: Other: Cognitive sensory motor relearning; Other: Sensory motor relearning; Other: Motor Relearning

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.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aruba Saeed, PhD; Phone Number: 03344399403; Email: aruba.saeed@riphah.edu.pk

Study Locations

• Pakistan
  • Punjab
    • Sheikhupura, Punjab, Pakistan, 39000
      • Recruiting
      • THQ Hospital, Muridke, Sheikhupura, Punjab
      • Contact: Aruba Saeed, PhD; Phone Number: 03344399403; Email: aruba.saeed@riphah.edu.pk
      • Principal Investigator: Hifsa Waheed, MSPT-NM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive sensory motor relearning Group; Cognitive, sensory, and motor training	Other: 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.
Experimental: Sensory Motor Relearning Group; Sensory and motor training	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.
Experimental: Motor Relearning Group; Motor training	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Action Research Arm Test	Changes from baseline The instrument contains 19 items grouped into 4 sub-tests: grasp, grip, pinch, and gross motor. Item performance is rated on a 4-point scale (0=unable; 1=partial; 2= abnormal; 3=normal) then item ratings are summed and reported out of 57 points with higher score indicating greater UE function.	6 weeks
Revised Nottingham Sensory Assessment (Somatosensory Impairments)	Changes from baseline rNSA examines somatosensory impairment using a 3-point scale (0 =absent, 1 = impaired, 2 = normal) and takes approximately 25-35 min to complete. It consists of 72 items grouped into three sub-scales measuring tactile sensation, proprioception, and stereognosis. The Tactile Sensation subscale includes light touch, temperature, pinprick, pressure, tactile localization, and bilateral simultaneous touch. Higher scores demonstrate better somatosensory function.	6 weeks
ABILHAND questionnaire (ABIL)	Changes from baseline ABILHAND is an inventory of 23 manual activities that the patient is originally asked to judge on a 3-level scale: 0 (impossible), 1 (difficult), and 2 (easy). The test explores bi-manual activities done without other human or technical help. For each question the patient provided his/her feeling of difficulty irrespective of the limb(s) actually used to do the activity. Activities not attempted in the last 3 months are not scored and encoded as missing responses.	6 weeks
MoCA (Montreal Cognitive Assessment)	Changes from baseline Montreal Cognitive Assessment (MoCA) is a one-page, 30-point cognitive screening measurement scale that takes about 10 minutes to administer. There are 12 subtasks in the MoCA test that include memory, visuospatial orientation, executive functioning, phonemic fluency, and two-item abstract thinking task, attention, concentration, and working memory, language, orientation to time and place. A score of 26 is a cutoff score to differentiate between normal and abnormal.	6 weeks

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Aruba Saeed, PhD, Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2023
• Primary Completion (Estimated): April 5, 2024
• Study Completion (Estimated): April 5, 2024

Study Registration Dates

• First Submitted: November 9, 2023
• First Submitted That Met QC Criteria: November 9, 2023
• First Posted (Actual): November 14, 2023

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: upper limb function; cognitive exercise therapy; sensory motor relearning
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: REC/ 0244 Hifsa Waheed

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No