NeuroReAlign Therapy for Cognitive Rehabilitation in Patients with Stroke

NCT ID: NCT06849128

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-15
• Study Completion Date: 2025-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Conventional cognitive training

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

NeuroReAlign Therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Middle East University

OTHER

Sponsor Role: lead

Responsible Party

Anas Radi Hassan Alashram

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

ADA/1100

Identifier Type: -

Identifier Source: org_study_id