NCT02232867

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Jul 2011

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 5, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

September 5, 2014

Status Verified

September 1, 2014

Enrollment Period

3.4 years

First QC Date

August 28, 2014

Last Update Submit

September 2, 2014

Conditions

Keywords

rehabilitationstrokewalkinginterlimb connections

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline, immediately post-intervention (average of 4 days following last exercise session)

Secondary Outcomes (6)

  • Interlimb Connections

    Baseline, immediately post-intervention (average of 4 days following the last exercise session)

  • Fugl-Meyer Assessment

    Baseline, immediately post-intervention (average of 4 days following the last exercise session)

  • Brunnstrom recovery stages

    Baseline, immediately post-intervention (average of 4 days following the last exercise session)

  • Timed up and go test

    Baseline, immediately post-intervention (average of 4 days following the last exercise session)

  • 10 meter walk test

    Baseline, immediately post-intervention (average of 4 days following the last exercise session)

  • +1 more secondary outcomes

Study Arms (1)

Arm and Leg Cycling Exercise Program

EXPERIMENTAL

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.

Behavioral: Arm and Leg Cycling Exercise Program

Interventions

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.

Arm and Leg Cycling Exercise Program

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • inability to stand for 5 minutes unassisted

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabilitation Neuroscience Laboratory

Victoria, British Columbia, V8W 3N4, Canada

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • E. Paul Zehr, PhD

    University of Victoria

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Taryn Klarner, M.Sc.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. E. Paul Zehr

Study Record Dates

First Submitted

August 28, 2014

First Posted

September 5, 2014

Study Start

July 1, 2011

Primary Completion

December 1, 2014

Study Completion

March 1, 2015

Last Updated

September 5, 2014

Record last verified: 2014-09

Locations