Clinical Application of Cross-education During Stroke Rehabilitation

NCT02948725 | Completed

• 1 other identifier: X-Ed-Stroke01
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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. 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. 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. 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

Outcome Measures

Primary Outcomes (1)

• Motor function scores as assessed using the Fugl-Meyer Assessment

  At 26 weeks

Secondary Outcomes (2)

• grip and wrist strength

  At 26 weeks

• volume of motor cortex activation

  At 26 weeks

Study Arms (2)

cross-education + standard rehabilitation

EXPERIMENTAL

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

standard rehabilitation

NO INTERVENTION

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.

Interventions

Cross-education + standard rehabilitation OTHER

cross-education + standard rehabilitation

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Saskatchewan: lead
• Saskatchewan Health Research Foundation: collaborator
• Royal University Hospital Foundation: collaborator

Study Sites (1)

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Jon Farthing, PhD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 26, 2016
• First Posted: October 28, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: May 11, 2023

Record last verified: 2023-05

Locations

CA (1)