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Impact of Training on Gait and Strength in Stroke Survivors

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
isokinetic lower-limb training
isokinetic upper-limb training
Sponsored by
Université de Montréal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, exercise, muscle strength, gait, rehabilitation

Eligibility Criteria

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

Inclusion Criteria:

  • have a chronic (six months or more) unilateral stroke
  • be able to walk 10 meters independently with or without a cane
  • present residual weakness at the affected lower limb
  • have an activity tolerance of at least two hours with a rest period

Exclusion Criteria:

  • receptive aphasia
  • incontinence
  • unstable medical condition
  • history of injury
  • anesthesia at the lower limbs

Sites / Locations

  • Institut de réadaptation Gingras-Lindsay

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

isokinetic lower-limb training

isokinetic uppe-limb training

Arm Description

3 times/week for 6 weeks

3 times/week for 6 weeks

Outcomes

Primary Outcome Measures

change in gait speed
change in gait speed, in meter/second, was assessed as the difference between the baseline and week #7 values.
change in peak positive power
peak positive power was evaluated at the affected plantarflexors, hip flexors and hip extensors. Also, change in peak positive power, in weight/kilogram, was assessed as the difference between the baseline and week #7 values.

Secondary Outcome Measures

change in maximal voluntary concentric strength
maximal voluntary concentric strength was evaluated at the affected plantarflexors, hip flexors and hip extensors. Also, change in maximal voluntary concentric strength, in Newton-metre, was assessed as the difference between the baseline and week #7 values.

Full Information

First Posted
March 15, 2013
Last Updated
March 21, 2013
Sponsor
Université de Montréal
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT01818349
Brief Title
Impact of Training on Gait and Strength in Stroke Survivors
Official Title
Gait Performance and Lower-limb Muscle Strength Improved in Both Upper-limb and Lower-limb Isokinetic Training Programs in Individuals With Chronic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Montréal
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Background: A discrepancy between strength gain and gait changes following various training programs aimed at improving gait function after stroke has been noted. A mismatch between the training program and gait parameters could explain this finding. Objective: To evaluate the impact of an isokinetic-strengthening program, matching the requirements of the affected lower-limb muscle groups involved in the energy generation of gait, to a control intervention, on gait performance and muscle strength. Hypothesis: The isokinetic training program of the affected lower-limb muscles would produce greater changes in gait performance and strength than a control intervention not aiming at training these muscle groups. Design: Single-blinded randomized controlled trial. Participants: A convenient sample of 30 individuals with chronic hemiparesis. Interventions: Participants were randomly assigned into two groups (n=15), each training three times/week for six weeks. The experimental group trained the affected plantarflexors, hip flexors and extensors concentrically, while the control group trained the affected upper-limb muscles. Main outcome measures: Baseline values and post-training values, taken at the end of the training program, of maximal voluntary concentric strength, gait speed and peak positive power.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, exercise, muscle strength, gait, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
isokinetic lower-limb training
Arm Type
Active Comparator
Arm Description
3 times/week for 6 weeks
Arm Title
isokinetic uppe-limb training
Arm Type
Placebo Comparator
Arm Description
3 times/week for 6 weeks
Intervention Type
Other
Intervention Name(s)
isokinetic lower-limb training
Intervention Description
concentric training of the affected plantarflexors, hip flexors and hip extensors
Intervention Type
Other
Intervention Name(s)
isokinetic upper-limb training
Intervention Description
concentric training of the affected wrist extensors, elbow flexors and shoulder flexors
Primary Outcome Measure Information:
Title
change in gait speed
Description
change in gait speed, in meter/second, was assessed as the difference between the baseline and week #7 values.
Time Frame
gait speed was assessed at baseline and at the completion of the 6-week training (i.e. week #7)
Title
change in peak positive power
Description
peak positive power was evaluated at the affected plantarflexors, hip flexors and hip extensors. Also, change in peak positive power, in weight/kilogram, was assessed as the difference between the baseline and week #7 values.
Time Frame
peak positive power was assessed at baseline and at the completion of the 6-week training (i.e. week #7)
Secondary Outcome Measure Information:
Title
change in maximal voluntary concentric strength
Description
maximal voluntary concentric strength was evaluated at the affected plantarflexors, hip flexors and hip extensors. Also, change in maximal voluntary concentric strength, in Newton-metre, was assessed as the difference between the baseline and week #7 values.
Time Frame
maximal voluntary concentric strength was assessed at baseline and at the completion of the 6-week training (i.e. week #7)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: have a chronic (six months or more) unilateral stroke be able to walk 10 meters independently with or without a cane present residual weakness at the affected lower limb have an activity tolerance of at least two hours with a rest period Exclusion Criteria: receptive aphasia incontinence unstable medical condition history of injury anesthesia at the lower limbs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvie Nadeau, PhD
Organizational Affiliation
Université de Montréal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de réadaptation Gingras-Lindsay
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3S 1M9
Country
Canada

12. IPD Sharing Statement

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Impact of Training on Gait and Strength in Stroke Survivors

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