Clinical Application of Cross-education During Stroke Rehabilitation

NCT ID: NCT02948725

Last Updated: 2023-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2022-12-31

Brief 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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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'.

Group Type: EXPERIMENTAL

Cross-education + standard rehabilitation

Intervention Type: OTHER

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cross-education + standard rehabilitation

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saskatchewan Health Research Foundation

OTHER

Sponsor Role: collaborator

Royal University Hospital Foundation

OTHER

Sponsor Role: collaborator

University of Saskatchewan

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Farthing

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jon Farthing, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan

Locations

Royal University Hospital

Saskatoon, Saskatchewan, Canada

Countries

Canada

Other Identifiers

X-Ed-Stroke01

Identifier Type: -

Identifier Source: org_study_id