Neuroarchitectural Recovery Model of Post-stroke Patients

NCT06825598 | Enrolling By Invitation

• 1 other identifier: NRMPSP
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The societal burden of stroke patients with persistent neurological deficit is high. It is therefore imperative that the mechanisms of rehabilitation-induced motor recovery be better understood in the hopes of developing more efficacious rehabilitative therapy. The treatment outcomes of people with stroke after rehabilitation vary, with up to 60% of people having residual impairment of the upper limb function. The high variability in rehabilitation-induced recovery prompted researchers and clinicians to develop more efficacious rehabilitative interventions for functional regain in post-stroke patients. However, the mechanisms underlying post-stroke functional regain have not been well articulated. The majority of studies in this area placed a limited scope on associating improvement in functions with changes in the activation of the motor cortices, ranging from normalization to the overactivity of the motor regions. A wider scope, however, needs to include structural changes in the motor cortices, as well as functional and structural changes in other neural substrates, as other non-motor cortices underpin stroke recovery. The results of our pilot study on acute post-stroke patients indicate that both functional and structural brain connections are significantly associated with motor recovery after conventional post-stroke rehabilitation. In addition to sensorimotor cortices, the investigators also found other non-motor areas, such as the superior frontal gyrus and the precuneus, that play important roles in post-stroke rehabilitation-induced recovery. Given the gap in elusive neural processes and in the mechanisms underlying rehabilitation-induced recovery, this proposed study is aimed at providing a better understanding of the functional regain of post-stroke patients by constructing a brain recovery model. As a first attempt, the investigators propose building a basic recovery model based on patients who will undergo constraint-induced movement therapy, a popular evidence-based post-stroke intervention, for capturing training-induced neuroplastic changes. Two groups of chronic stroke patients will be recruited, respectively, for the treatment and control groups. Magnetic resonance imaging (used to map functional and structural brain connections), the clinical assessments of motor impairments, and activities of daily living will be conducted at four time points-namely at the baseline, one week, four weeks, and three months after the treatment commences. The two objectives set for the proposed study are: (1) to characterize the longitudinal changes in functional and structural brain networks, which would differentiate the rate of changes in these networks; and (2) to define the functional and the structural brain network coupling, as well as their contributions to the daily function regain.

Conditions

Stroke

Keywords

CIMT; Recovery; Mechanism; Stroke; Connectivity

Outcome Measures

Primary Outcomes (1)

• Rehabilitation outcome

  The Fugl-Meyer Motor Scale and Barthel Index will be used as the outcome measures

  From enrollment to two weeks after the end of treatment

Study Arms (2)

Constraint-induced movement therapy

ACTIVE COMPARATOR

Constraint-induced movement therapy is a therapy for post-stroke patients in the hope of improving their movement functions

Behavioral: Constraint-induced movement therapy

Magnetic resonance imaging

EXPERIMENTAL

Magnetic resonance imaging (MRI) is performed to monitor the changes that will occur in the brain of post-stroke patients along the course of intervention

Diagnostic Test: Magnetic resonance imaging

Interventions

Constraint-induced movement therapy BEHAVIORAL

Constraint-induced movement therapy is a therapy for post-stroke patients to improve their motor functions

Constraint-induced movement therapy

Magnetic resonance imaging DIAGNOSTIC_TEST

Magnetic resonance imaging is performed to monitor the changes in the brain of post-stroke patients along the course of intervention

Magnetic resonance imaging

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic post-stroke patients between 50 and 80 years old, and with the first-time ischemic stroke occurring three months or more after onset will be recruited to participate in the study. The reason for choosing chronic post-stroke patients is to minimize the effect of spontaneous recovery,55 which may confound the treatment-induced recovery. The recruited patients should present with motor deficits in the upper and/or lower extremities due to the stroke as measured using the Fugl-Meyer Motor Scale

You may not qualify if:

• Patients with voluntary extension ≤ 10° in the metacarpophalangeal or interphalangeal joints, or ≤ 20° in the wrist; severe balance or walking disorders as indicated by the need for assistance in any activities of daily living; significant cognitive decline (score \<16) measured with the The Hong Kong version of Montreal Cognitive Assessment (HK-MoCA);56 or a history of prior stroke, brain neoplasm, intracranial hemorrhages, transient ischemic attacks, diffusion abnormalities due to nonvascular etiology (for example, posterior reversible encephalopathy syndrome or global hypoxic ischemic encephalopathy), or other neurological/psychiatric or medical conditions that preclude active participation in research and/or may alter the interpretation of the behavioral/imaging studies (e.g., dementia, schizophrenia)

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• The Hong Kong Polytechnic University: collaborator

Study Sites (1)

The Polytechnic University of Hong Kong

Hung Hom, Hong Kong

Location

MeSH Terms

Conditions

Stroke

Interventions

Constraint Induced Movement Therapy; Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise Therapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Sai Kam Hui, Ph.D.

  Chinese University of Hong Kong

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 13, 2025
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 14, 2025

Record last verified: 2024-11

Locations

HK (1)