NeuroReAlign Therapy for Cognitive Rehabilitation in Patients with Stroke

NCT06849128 | Not Yet Recruiting DMC

• 1 other identifier: ADA/1100
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Mini-Mental State Examination (MMSE)

  At baseline (week 0) and post-intervention (week 4)

• Trail Making Test (TMT)

  At baseline (week 0) and post-intervention (week 4)

• Stroop Test

  At baseline (week 0) and post-intervention (week 4)

• Digit Span Test

  At baseline (week 0) and post-intervention (week 4)

• Verbal Fluency Test (VFT)

  At baseline (week 0) and post-intervention (week 4)

Study Arms (2)

Conventional cognitive training

ACTIVE COMPARATOR

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

NeuroReAlign Therapy

EXPERIMENTAL

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

Interventions

NeuroReAlign Therapy OTHER

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.

NeuroReAlign Therapy

Conventional cognitive training OTHER

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.

Conventional cognitive training

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with severe cognitive impairments
• Patients cannot walk independently

Sponsors & Collaborators

• Middle East University: lead

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 27, 2025
• Study Start: March 15, 2025
• Primary Completion: April 15, 2025
• Study Completion: April 30, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03