NeuroReAlign Therapy for Balance and Gait Rehabilitation in Stroke Survivors

NCT06849102 | Not Yet Recruiting DMC

• 1 other identifier: ADA/1099
• 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 balance and gait 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 balance in stroke survivors compared to conventional physiotherapy? Does NeuroReAlign Therapy enhance gait performance more effectively than conventional physiotherapy? Researchers will compare NeuroReAlign Therapy to conventional physiotherapy to determine its effects on balance and gait. Participants will: Undergo NeuroReAlign Therapy or conventional physiotherapy for 4 weeks. Have their balance assessed using the Berg Balance Scale (BBS), Activities-Specific Balance Confidence Scale (ABC Scale), and Fear of Falling Questionnaire (FoFQ). Have their gait evaluated using the Dynamic Gait Index (DGI), Rivermead Mobility Index (RMI), Timed Up and Go (TUG), 6-Minute Walk Test (6MWT), and 10-Meter Walk Test (10MWT). Complete outcome assessments at baseline and after the intervention (week 4).

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Dynamic Gait Index (DGI)

  The Dynamic Gait Index (DGI) is a clinical tool designed to assess an individual's ability to adapt gait to varying task demands, particularly in populations with neurological conditions such as stroke, Parkinson's disease, and vestibular disorders. It consists of eight walking-related tasks, including changes in gait speed, head movements, obstacle navigation, and stair climbing, each scored on a 4-point scale (0-3), with a maximum total score of 24. Lower scores indicate greater impairment and a higher risk of falls, with a cutoff score of ≤19 suggesting increased fall risk. The DGI is widely used in rehabilitation settings to evaluate functional mobility, guide treatment planning, and monitor progress in individuals with balance and gait deficits.

  At baseline (week 0) and after the intervention (week 4)

Secondary Outcomes (7)

• Berg Balance Scale (BBS)

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

• Activities-Specific Balance Confidence Scale (ABC Scale)

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

• Fear of Falling Questionnaire (FoFQ)

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

• Rivermead Mobility Index (RMI)

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

• Timed Up and Go (TUG)

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

Study Arms (2)

Conventional Physiotherapy

ACTIVE COMPARATOR

Patients in this group will receive conventional physiotherapy interventions, including treadmill training, balance training, strengthening and stretching lower limb muscles, for 45 minutes per session, 3 times weekly, for 4 weeks.

Other: conventional physiotherapy interventions

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 physiotherapy interventions OTHER

Patients in this group will receive conventional physiotherapy interventions, including treadmill training, balance training, strengthening and stretching lower limb muscles, for 45 minutes per session, 3 times weekly, for 4 weeks.

Conventional Physiotherapy

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 1, 2025
• Primary Completion: April 10, 2025
• Study Completion: April 20, 2025
• Last Updated: February 27, 2025

Record last verified: 2025-02