Clinical Application of Cross-education During Stroke Rehabilitation (X-Ed-Stroke01)

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: Cross-education + standard rehabilitation

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • Royal University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cross-education + standard rehabilitation; The cross-education group will engage in strength training of the non-paretic hand in addition to standard rehabilitation. Cross-education will be progressive in nature, beginning with 2 sets of 8 repetitions and increasing up to a maximum of 6 sets of 8 repetitions of maximal voluntary effort isometric handgrip contractions as tolerated. Grip training will be performed using standard grip trainers (Digi-Flex Grip trainers) to train both finger flexors and full hand and wrist isometric contractions. In addition, patients will perform controlled dynamic wrist flexion and extension training of the non-paretic hand using exercise tubing with the same prescription. Patients will be asked to complete exercises 3 times per week for 26 weeks, and to record adherence in a training log. An average of one session per week will be considered 'trained'.	Other: Cross-education + standard rehabilitation
No Intervention: standard rehabilitation; Standardized rehabilitation involves several strategies tailored to the patient and remains somewhat based on clinician preference. These therapies may involve functional electrical stimulation, neuro-facilitation, strengthening, range of motion (ROM), mirror therapy, and force-use therapy (e.g., CIMT). Patients engage in therapy 5 days per week as inpatients, and 2 days per week as outpatients with additional home exercises. Specific therapies for each patient will be tracked using a therapy log.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Motor function scores as assessed using the Fugl-Meyer Assessment	At 26 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
grip and wrist strength	At 26 weeks
volume of motor cortex activation	At 26 weeks

Collaborators and Investigators

• Sponsor: University of Saskatchewan
• Collaborators: Saskatchewan Health Research Foundation; Royal University Hospital Foundation
• Investigators: Principal Investigator: Jon Farthing, PhD, University of Saskatchewan

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: October 26, 2016
• First Submitted That Met QC Criteria: October 27, 2016
• First Posted (Estimate): October 28, 2016

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: X-Ed-Stroke01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Co-Investigators will have access to the data. Plans beyond that