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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cross-education + standard rehabilitation
Sponsored by
University of Saskatchewan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

cross-education + standard rehabilitation

standard rehabilitation

Arm Description

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'.

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.

Outcomes

Primary Outcome Measures

Motor function scores as assessed using the Fugl-Meyer Assessment

Secondary Outcome Measures

grip and wrist strength
volume of motor cortex activation

Full Information

First Posted
October 26, 2016
Last Updated
May 10, 2023
Sponsor
University of Saskatchewan
Collaborators
Saskatchewan Health Research Foundation, Royal University Hospital Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02948725
Brief Title
Clinical Application of Cross-education During Stroke Rehabilitation
Acronym
X-Ed-Stroke01
Official Title
Clinical Application of Cross-education During Stroke Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
December 2021 (Actual)
Study Completion Date
December 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan
Collaborators
Saskatchewan Health Research Foundation, Royal University Hospital Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: To determine if cross-education, in addition to standard rehabilitation leads to better recovery of upper limb function for stroke patients with hemiparesis. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cross-education + standard rehabilitation
Arm Type
Experimental
Arm Description
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'.
Arm Title
standard rehabilitation
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cross-education + standard rehabilitation
Primary Outcome Measure Information:
Title
Motor function scores as assessed using the Fugl-Meyer Assessment
Time Frame
At 26 weeks
Secondary Outcome Measure Information:
Title
grip and wrist strength
Time Frame
At 26 weeks
Title
volume of motor cortex activation
Time Frame
At 26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon Farthing, PhD
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Co-Investigators will have access to the data. Plans beyond that

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Clinical Application of Cross-education During Stroke Rehabilitation

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