- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01818349
Impact of Training on Gait and Strength in Stroke Survivors
Gait Performance and Lower-limb Muscle Strength Improved in Both Upper-limb and Lower-limb Isokinetic Training Programs in Individuals With Chronic Stroke
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Montréal, Quebec, Canada, H3S 1M9
- Institut de réadaptation Gingras-Lindsay
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: isokinetic lower-limb training
3 times/week for 6 weeks
|
concentric training of the affected plantarflexors, hip flexors and hip extensors
|
|
Placebo Comparator: isokinetic uppe-limb training
3 times/week for 6 weeks
|
concentric training of the affected wrist extensors, elbow flexors and shoulder flexors
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in gait speed
Time Frame: gait speed was assessed at baseline and at the completion of the 6-week training (i.e. week #7)
|
change in gait speed, in meter/second, was assessed as the difference between the baseline and week #7 values.
|
gait speed was assessed at baseline and at the completion of the 6-week training (i.e. week #7)
|
|
change in peak positive power
Time Frame: peak positive power was assessed at baseline and at the completion of the 6-week training (i.e. week #7)
|
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.
|
peak positive power was assessed at baseline and at the completion of the 6-week training (i.e. week #7)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in maximal voluntary concentric strength
Time Frame: maximal voluntary concentric strength was assessed at baseline and at the completion of the 6-week training (i.e. week #7)
|
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.
|
maximal voluntary concentric strength was assessed at baseline and at the completion of the 6-week training (i.e. week #7)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sylvie Nadeau, PhD, Université de Montréal
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRSC-44059
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stroke
-
National Assembly ClinicBayero University Kano, NigeriaRecruitingStroke | Stroke Hemorrhagic | Stroke Ischemic | Hemiparesis After StrokeNigeria
-
University of PittsburghRecruitingHemorrhagic Stroke | Embolic Stroke of Undetermined Source | Ischemic Stroke, Cryptogenic | Recurrent Ischemic Stroke | Ischemic Stroke, EmbolicUnited States
-
Mahidol UniversityNot yet recruitingIschemic Stroke | Hemorrhagic Stroke | Subacute Stroke | Chronic Stroke SurvivorsThailand
-
Mahidol UniversityRecruitingIschemic Stroke | Hemorrhagic Stroke | Subacute Stroke | Chronic Stroke PatientThailand
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
University of Illinois at ChicagoRecruitingStroke, Ischemic | Stroke Hemorrhagic | Stroke, CerebrovascularUnited States
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
-
Samsung Medical CenterCompletedChronic Stroke | Subacute Stroke | ExoskeletonSouth Korea
-
Fondazione Don Carlo Gnocchi OnlusScuola Superiore Sant'Anna di Pisa; Fondazione Policlinico Universitario Campus...Not yet recruitingStroke | Stroke Hemorrhagic | Upper Limb Rehabilitation | Stroke IschemicItaly
Clinical Trials on isokinetic lower-limb training
-
National and Kapodistrian University of AthensCompletedMenstrual Cycle | Exercise Performance ImpairmentGreece
-
Riphah International UniversityCompletedSports Physical TherapyPakistan
-
Muğla Sıtkı Koçman UniversityCompleted
-
Riphah International UniversityCompleted
-
Riphah International UniversityCompletedCerebral Palsy,DiplegicPakistan
-
Centro Universitario La SalleRecruitingResistance Training | Local Hypoalgesia | Distal Hypoalgesia | Pressure Pain ThresholdsSpain
-
Riphah International UniversityActive, not recruitingStroke | Rehabilitation | Gait BalancePakistan
-
National Taipei University of Nursing and Health...CompletedPatients With Chronic SchizophreniaTaiwan
-
Rong WenchaoCompleted
-
The Hong Kong Polytechnic UniversityRecruiting