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

NCT06130891 | Completed DMC

• 1 other identifier: REC/ 0244 Hifsa Waheed
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Ischemic

Keywords

cognitive exercise therapy; sensory motor relearning; upper limb function

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

Cognitive sensory motor relearning Group

EXPERIMENTAL

Cognitive, sensory, and motor training

Other: Cognitive sensory motor relearning

Sensory Motor Relearning Group

EXPERIMENTAL

Sensory and motor training

Other: Sensory motor relearning

Motor Relearning Group

EXPERIMENTAL

Motor training

Other: Motor Relearning

Interventions

Cognitive sensory motor relearning 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.

Cognitive sensory motor relearning Group

Sensory motor relearning 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.

Sensory Motor Relearning Group

Motor Relearning 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.

Motor Relearning Group

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Both male and female patients.
• years of age.
• st ever stroke.
• Sub-acute ischemic stroke.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

THQ Hospital, Muridke, Sheikhupura, Punjab

Sheikhupura, Punjab Province, 39000, Pakistan

Location

MeSH Terms

Conditions

Stroke; Ischemia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Aruba Saeed, PhD

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 14, 2023
• Study Start: November 5, 2023
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)