Rehabilitation of Stroke Patients for Maximal Neurological Restoration

NCT05086055 | Unknown

• 1 other identifier: 171264
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 3

Brief Summary

Multimodal imaging of stroke patients. Patients included in the study will be investigated with multiparametric imaging tools including MRI and EEG imaging. Improvements in motor skills will be monitored clinically.

Conditions

Stroke

Keywords

Rehabilitation

Outcome Measures

Primary Outcomes (4)

• Changes in brain volume

  Stroke induced brain volume changes (mm3) will be measured using magnetic resonance imaging (MRI) at 1 day and 6 months post-stroke.

  6 months

• Stroke induced changes in brain activity.

  Document longitudinal changes in brain activity using EEG. Changes will be measured in cycles/second (Hertz, Hz).

  6 months

• Changes in inflammatory activity in brain

  Markers of post-stroke inflammation will be measured in pg/ml and ng/ml.

  6 months

• muscle function

  Longitudinal kinematic profiling. Electromyography measurements of muscle function post-stroke will be measured in cycles/second (Hz) and amplitude (mm). Extension and flexion of arm will be measured in cm. Joint angles will be measured in degrees. Speed of flexion and extension will be measured in cm/second

  6 months

Study Arms (2)

Stroke patients

Stroke patients admitted to the stroke unit, St Olav´s hospital, Trondheim, Norway, without previous stroke, neurological disease or central nervous system (CNS) trauma, will be eligible for inclusion into the study. The planned cohort size is 135 patients.

Behavioral: Kinematic movement analysis

healthy volunteers

Age and gender matched controls without previous CNS disease or trauma are eligible for inclusion into the study. Estimated cohort size is 45 individuals. Volunteers will be recruited through announcement in local newspaper.

Behavioral: Kinematic movement analysis

Interventions

Kinematic movement analysis BEHAVIORAL

moving arm/leg while registration with electromyography, electroencephalogram, accelerometers, functional near infrared spectroscopy and 3 dimensional video registration of hand, arm, foot and leg movements.

Stroke patients; healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients 18-years or older of both sexes with subcortical strokes resulting in arm motor deficit, admitted to the stroke unit, St Olav´s Hospital during 2020-2023. All patients admitted to the stroke unit will be scored according to National Institute of Health Score Scale (NIHSS) and the modified Rankin score (mRS) to establish the baseline clinical assessment of neurological dysfunction prior to inclusion

You may qualify if:

• subcortical strokes resulting in arm motor deficits.
• admitted to the stroke unit, St Olav´s Hospital during 2021-2023

You may not qualify if:

• Previous stroke
• neurodegenerative disease
• brain tumors
• previous neurotrauma or brain operation
• aphasia
• cognitive dysfunction and claustrophobia preventing MRI examinations.

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator
• OsloMet: collaborator

Study Sites (3)

OsloMet

Oslo, Norway

RECRUITING

NextMove, NTNU

Trondheim, Norway

RECRUITING

St Olavs Hospital Stroke Unit

Trondheim, Norway

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Axel Sandvig, PhD prof

  Norwegian University of Science and Technology

  PRINCIPAL INVESTIGATOR

• Jorunn Helbostad, PhD prof

  Norwegian University of Science and Technology

  STUDY DIRECTOR

• Bent Indredavik, PhD prof

  St. Olavs Hospital

  STUDY DIRECTOR

Central Study Contacts

Axel Sandvig, PhD ass prof

CONTACT

+46 72575620; axel.sandvig@ntnu.no

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: October 20, 2021
• Study Start: November 11, 2021
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (3)