Clinical Application of Cross-education During Stroke Rehabilitation

Stroke Clinical Trial

— X-Ed-Stroke01  

Official title:

Clinical Application of Cross-education During Stroke Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02948725
• Other study ID #: X-Ed-Stroke01
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: December 2022

Study information

• Verified date: May 2023
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Cross-education + standard rehabilitation

Locations

Country	Name	City	State
Canada	Royal University Hospital	Saskatoon	Saskatchewan

Sponsors (3)

Lead Sponsor	Collaborator
University of Saskatchewan	Royal University Hospital Foundation, Saskatchewan Health Research Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor function scores as assessed using the Fugl-Meyer Assessment		At 26 weeks
Secondary	grip and wrist strength		At 26 weeks
Secondary	volume of motor cortex activation		At 26 weeks