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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06130891
• Other study ID #: REC/ 0244 Hifsa Waheed
• Status: Completed
• Phase: N/A
• Start date: November 5, 2023
• Est. completion date: March 30, 2024

Study information

• Verified date: May 2024
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ischemic
• Stroke

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Pakistan	THQ Hospital, Muridke, Sheikhupura, Punjab	Sheikhupura	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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