NeuroReAlign Therapy for Cognitive Rehabilitation in Patients with Stroke

Effects of NeuroReAlign Therapy on Cognition in Patients with Stroke: a Randomized Controlled Trial

The goal of this randomized controlled trial is to investigate the effects of NeuroReAlign Therapy on cognition in stroke survivors in the chronic stage (>6 months). The study will include male and female participants aged 18-70 years.

The main questions it aims to answer are:

Does NeuroReAlign Therapy improve cognition in stroke survivors compared to conventional physiotherapy? Researchers will compare NeuroReAlign Therapy to conventional cognitive therapy to determine its effects on cognition.

Participants will:

Undergo NeuroReAlign Therapy or conventional cognitive therapy for 4 weeks. Have their cognition evaluated using the Montreal Cognitive Assessment (MoCA), Mini-Mental State Examination (MMSE), Trail Making Test (TMT), Stroop Test, Digit Span Test, and Verbal Fluency Test (VFT).

Complete outcome assessments at baseline and after the intervention (week 4).

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: Conventional cognitive training; Other: NeuroReAlign Therapy

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patients with ischemic or hemorrhagic stroke
• Have a stroke more than 6 months
• Age between 18 and 70

Exclusion Criteria:

• Patients with severe cognitive impairments
• Patients cannot walk independently

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional cognitive training; A conventional cognitive training protocol involves structured, repetitive exercises designed to enhance specific cognitive functions, such as memory, attention, executive function, and processing speed. These training programs are delivered through paper-and-pencil tasks, computer-based exercises, and therapist-guided activities. Tasks used include working memory exercises (e.g., digit span recall), attention training (e.g., Stroop test, visual scanning), problem-solving activities (e.g., Tower of Hanoi), and language exercises (e.g., verbal fluency tasks), for 45 minutes per session, 3 times weekly, for 4 weeks.	Other: Conventional cognitive training; A conventional cognitive training protocol involves structured, repetitive exercises designed to enhance specific cognitive functions, such as memory, attention, executive function, and processing speed. These training programs are delivered through paper-and-pencil tasks, computer-based exercises, and therapist-guided activities. Tasks used include working memory exercises (e.g., digit span recall), attention training (e.g., Stroop test, visual scanning), problem-solving activities (e.g., Tower of Hanoi), and language exercises (e.g., verbal fluency tasks), for 45 minutes per session, 3 times weekly, for 4 weeks.
Experimental: NeuroReAlign Therapy; Patients in this group will receive NeuroReAlign Therapy, including motor training (e.g., treadmill training, balance training), multimodal sensory stimulation (e.g., proprioceptive and visual), cognitive training (e.g., traditional cognitive exercise), and motivation, for 45 minutes per session, 3 times weekly, for 4 weeks.	Other: NeuroReAlign Therapy; Patients in this group will receive NeuroReAlign Therapy, including motor training (e.g., treadmill training, balance training), multimodal sensory stimulation (e.g., proprioceptive and visual), cognitive training (e.g., traditional cognitive exercise), and motivation, for 45 minutes per session, 3 times weekly, for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montreal Cognitive Assessment (MoCA)	The Montreal Cognitive Assessment (MoCA) is a widely used screening tool designed to assess mild cognitive impairment in stroke survivors and other neurological populations. It evaluates multiple cognitive domains, including attention, memory, visuospatial abilities, executive function, language, and orientation. The test consists of 30 points, with a cutoff score of <26 suggesting cognitive impairment. The MoCA is sensitive to subtle cognitive deficits and is particularly useful in detecting post-stroke cognitive impairments that may not be captured by other general cognitive tests.	At baseline (week 0) and post-intervention (week 4)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mini-Mental State Examination (MMSE)	The Mini-Mental State Examination (MMSE) is a brief, standardized cognitive test used to assess overall cognitive function in stroke survivors. It evaluates orientation, attention, memory, language, and visuospatial skills, with a total score of 30 points. Lower scores indicate greater cognitive impairment, with a cutoff of ≤24 typically suggesting cognitive dysfunction. Although widely used, the MMSE may be less sensitive to detecting mild cognitive impairment compared to the Montreal Cognitive Assessment (MoCA).	At baseline (week 0) and post-intervention (week 4)
Trail Making Test (TMT)	The Trail Making Test (TMT) is a neuropsychological test used to assess processing speed, attention, and executive function in stroke survivors. It consists of two parts: TMT part A, where participants connect numbers in ascending order to measure processing speed and visual search, and TMT part B, where they alternate between numbers and letters (1-A-2-B, etc.) to assess cognitive flexibility and executive function. Longer completion times indicate greater impairment. The TMT is widely used to evaluate cognitive deficits following stroke, particularly in domains related to attention and task-switching.	At baseline (week 0) and post-intervention (week 4)
Stroop Test	The Stroop Test assesses cognitive control, attention, and response inhibition, which are often affected after a stroke. It requires participants to name the color of printed words while ignoring the actual word meaning (e.g., saying "blue" when the word "RED" is printed in blue ink). The test measures processing speed, selective attention, and executive function by evaluating the ability to suppress automatic responses. Poor performance on the Stroop Test may indicate deficits in cognitive control and attention regulation, which are common in post-stroke cognitive impairment.	At baseline (week 0) and post-intervention (week 4)
Digit Span Test	The Digit Span Test, a subtest of the Wechsler Adult Intelligence Scale (WAIS), assesses attention, working memory, and verbal short-term memory. Participants are asked to repeat a series of numbers in the same order (forward digit span) or in reverse order (backward digit span). The backward span is particularly sensitive to working memory deficits, which are frequently observed in stroke survivors. This test is simple yet effective in evaluating short-term memory and cognitive processing capacity.	At baseline (week 0) and post-intervention (week 4)
Verbal Fluency Test (VFT)	The Verbal Fluency Test (VFT) measures language function, executive control, and processing speed. It consists of two types: phonemic fluency, where participants generate words starting with a specific letter, and semantic fluency, where they list words within a given category (e.g., animals). The number of correct words generated within a time limit (usually 60 seconds) reflects cognitive function, with lower scores indicating language or executive dysfunction. This test is commonly used to assess cognitive deficits in post-stroke patients, particularly those affecting language and retrieval ability.	At baseline (week 0) and post-intervention (week 4)

Collaborators and Investigators

• Sponsor: Middle East University

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2025
• Primary Completion (Estimated): April 15, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: February 20, 2025
• First Submitted That Met QC Criteria: February 24, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 13, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: ADA/1100

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No