Clinical Application of Cross-education During Stroke Rehabilitation

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: Cross-education + standard rehabilitation

• Registration Number: NCT02948725
• Lead Sponsor: University of Saskatchewan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-26
• Study First Submitted QC: 2016-10-27
• Study First Posted: 2016-10-28
• Study Start: 2016-11
• Primary Completion: 2021-12
• Study Completion: 2022-12
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-10
• Last Update Posted: 2023-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cross-education + standard rehabilitation	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'.

Primary Outcome Measures

Name	Time	Method
Motor function scores as assessed using the Fugl-Meyer Assessment	At 26 weeks

Secondary Outcome Measures

Name	Time	Method
grip and wrist strength	At 26 weeks
volume of motor cortex activation	At 26 weeks

Trial Locations

Locations (1)

Royal University Hospital; 🇨🇦 Saskatoon, Saskatchewan, Canada