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Arm and Leg Cycling Exercise After Stroke

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Arm and Leg Cycling Exercise Program
Sponsored by
University of Victoria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring rehabilitation, stroke, walking, interlimb connections

Eligibility Criteria

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

Inclusion Criteria:

  • stroke
  • lives within the Victoria, Vancouver Island, and Vancouver mainland communities

Exclusion Criteria:

  • inability to stand for 5 minutes unassisted

Sites / Locations

  • Rehabilitation Neuroscience LaboratoryRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm and Leg Cycling Exercise Program

Arm Description

Multiple baseline test sessions will be used for the same participant to establish a meaningful baseline thus confirming consistency of all outcome measures prior to the intervention.

Outcomes

Primary Outcome Measures

Change in Treadmill Walking Characteristics
Treadmill walking characteristics will be gauged via a customized analysis of muscle activity patterns and lower limb joint kinematics. Walking frequency, symmetry, and timing will also be analyzed

Secondary Outcome Measures

Interlimb Connections
To assess the strength of inter-limb coupling, simultaneous electrical stimulation will be applied to (5x1.0ms trains at 300Hz) the cutaneous nerves in the hand (superficial radial) and foot (superficial peroneal). The reflex responses recorded in all four limbs will be evaluated at different phases of the walking cycle.
Fugl-Meyer Assessment
The Fugl-Meyer Assessment is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
Brunnstrom recovery stages
The Brunnstrom Approach emphasises the synergic pattern of movement which develops during recovery from hemiplegia.
Timed up and go test
The Timed Up and Go test is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three metres, turn around, walk back to the chair, and sit down. During the test, the person is expected to wear their regular footwear and use any mobility aids that they would normally require.
10 meter walk test
The 10 meter walk test is a timed test to evaluate walking speed
Six minute walk test
The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.

Full Information

First Posted
August 28, 2014
Last Updated
September 2, 2014
Sponsor
University of Victoria
Collaborators
Heart and Stroke Foundation of Canada, Canadian Stroke Network
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1. Study Identification

Unique Protocol Identification Number
NCT02232867
Brief Title
Arm and Leg Cycling Exercise After Stroke
Official Title
Adjunct Locomotor Training to Improve Walking Ability After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
March 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Victoria
Collaborators
Heart and Stroke Foundation of Canada, Canadian Stroke Network

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
It has been found that arm and leg cycling is similar to walking in terms of the muscle activation patterns and joint ranges of motion. In addition, arm and leg cycling and walking activate similar neural pathways. Another advantage of arm and leg cycling is that it involves coordination of all four limbs in a rhythmic movement. This may be particularly beneficial given previous findings that arm movement contributes to the activation of leg muscles during walking in humans. This is achieved with interconnected neural pathways that link the arms to the legs. These neural interlimb connections remain intact in stroke victims, such that maximizing the contribution of the arms to the legs may increase coordination for walking. Thus, the objectives of this research are to determine if arm and leg cycling can be used to increase the strength of interlimb connections and if this helps to improve walking ability in a post-stroke population. It is hypothesized that arm and leg cycling will transfer to improvements in walking in a post stroke population.
Detailed Description
For those who have suffered a stroke, damage to the brain can result in a decreased ability to walk, thus decreasing quality of life in a significant way. Traditionally, body weight supported treadmill training has been used for walking rehabilitation; however, this therapy requires specialized technicians, equipment, and facilities. Arm and leg cycle ergometers, a device commonly found in a gym, could provide an inexpensive and readily accessible means for walking rehabilitation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
rehabilitation, stroke, walking, interlimb connections

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm and Leg Cycling Exercise Program
Arm Type
Experimental
Arm Description
Multiple baseline test sessions will be used for the same participant to establish a meaningful baseline thus confirming consistency of all outcome measures prior to the intervention.
Intervention Type
Behavioral
Intervention Name(s)
Arm and Leg Cycling Exercise Program
Intervention Description
Participants will perform arm and leg cycling training three times a week, with 30 minutes of aggregate exercise time per session. To evaluate the physiological cost of exercise, heart rate and a rating of perceived exertion will be collected. The progressive element of this training will include increasing the resistance of the ergometer over the six weeks in order to maintain the same relative exercise stress.
Primary Outcome Measure Information:
Title
Change in Treadmill Walking Characteristics
Description
Treadmill walking characteristics will be gauged via a customized analysis of muscle activity patterns and lower limb joint kinematics. Walking frequency, symmetry, and timing will also be analyzed
Time Frame
Baseline, immediately post-intervention (average of 4 days following last exercise session)
Secondary Outcome Measure Information:
Title
Interlimb Connections
Description
To assess the strength of inter-limb coupling, simultaneous electrical stimulation will be applied to (5x1.0ms trains at 300Hz) the cutaneous nerves in the hand (superficial radial) and foot (superficial peroneal). The reflex responses recorded in all four limbs will be evaluated at different phases of the walking cycle.
Time Frame
Baseline, immediately post-intervention (average of 4 days following the last exercise session)
Title
Fugl-Meyer Assessment
Description
The Fugl-Meyer Assessment is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
Time Frame
Baseline, immediately post-intervention (average of 4 days following the last exercise session)
Title
Brunnstrom recovery stages
Description
The Brunnstrom Approach emphasises the synergic pattern of movement which develops during recovery from hemiplegia.
Time Frame
Baseline, immediately post-intervention (average of 4 days following the last exercise session)
Title
Timed up and go test
Description
The Timed Up and Go test is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three metres, turn around, walk back to the chair, and sit down. During the test, the person is expected to wear their regular footwear and use any mobility aids that they would normally require.
Time Frame
Baseline, immediately post-intervention (average of 4 days following the last exercise session)
Title
10 meter walk test
Description
The 10 meter walk test is a timed test to evaluate walking speed
Time Frame
Baseline, immediately post-intervention (average of 4 days following the last exercise session)
Title
Six minute walk test
Description
The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.
Time Frame
Baseline, immediately post-intervention (average of 4 days following last exercise session)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: stroke lives within the Victoria, Vancouver Island, and Vancouver mainland communities Exclusion Criteria: inability to stand for 5 minutes unassisted
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Taryn Klarner, M.Sc.
Phone
(250) 472-5487
Email
rnl@uvic.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
E. Paul Zehr, PhD
Organizational Affiliation
University of Victoria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehabilitation Neuroscience Laboratory
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8W 3N4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marj Wilder, B.Sc.
Email
mwilder@uvic.ca
First Name & Middle Initial & Last Name & Degree
E Paul Zehr, PhD

12. IPD Sharing Statement

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Arm and Leg Cycling Exercise After Stroke

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