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Completed

NCT Number: NCT02948725

Clinical Application of Cross-education During Stroke Rehabilitation

Based on the current state of knowledge and gaps in the literature we will conduct an intervention study to explore novel treatment and rehabilitation of patients at Royal University Hospital (RUH) with motor deficits following stroke. This project has the following objectives:

1. To determine if cross-education, in addition to standard rehabilitation leads to better recovery of upper limb function for stroke patients with hemiparesis. 2. To incorporate functional brain activation as measured by functional magnetic resonance imaging (fMRI) to examine the neural mechanisms associated with changes in motor function of the paretic arm post-stroke. 3. To use diffusion tensor imaging (DTI) tractography to measure connectivity and examine the extent to which white matter tract thickness correlates with preserved motor output in patients post-stroke.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or older
  • within 18 months of stroke recovery
  • medically stable
  • ambulatory
  • have moderate to severe upper limb hemiparesis as diagnosed by clinicians
  • Consent

Exclusion criteria

  • significant cognitive impairment or aphasia affecting understanding, as assessed by clinician
  • severe upper limb spasticity preventing any movement of the proximal arm and shoulder
  • diagnosis of hemorrhagic or bilateral stroke
  • history of other severe upper limb musculoskeletal injury
  • other neurological diseases
  • intracranial metal clips or cardiac pacemaker, or anything that would preclude an MRI
  • Any condition that would preclude the participant's ability to attend follow-up visits in the opinion of the Investigator

Treatment and study plan

Cross-education + standard rehabilitation

Other

Primary outcomes

  1. Motor function scores as assessed using the Fugl-Meyer Assessment

    Time frame: At 26 weeks

Secondary outcomes

  1. grip and wrist strength

    Time frame: At 26 weeks

  2. volume of motor cortex activation

    Time frame: At 26 weeks

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Collaborators

  • Royal University Hospital Foundation
  • Saskatchewan Health Research Foundation

Registry information

Acronym: X-Ed-Stroke01

Important dates

Study start
2016
Primary completion
2021
Study completion
2022
First posted
Oct 28, 2016
Registry last updated
May 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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