NCT01818349

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Mar 2002

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2002

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 26, 2013

Completed
Last Updated

March 26, 2013

Status Verified

March 1, 2013

Enrollment Period

3.8 years

First QC Date

March 15, 2013

Last Update Submit

March 21, 2013

Conditions

Keywords

strokeexercisemuscle strengthgaitrehabilitation

Outcome Measures

Primary Outcomes (2)

  • change in gait speed

    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

    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 Outcomes (1)

  • change in maximal voluntary concentric strength

    maximal voluntary concentric strength was assessed at baseline and at the completion of the 6-week training (i.e. week #7)

Study Arms (2)

isokinetic lower-limb training

ACTIVE COMPARATOR

3 times/week for 6 weeks

Other: isokinetic lower-limb training

isokinetic uppe-limb training

PLACEBO COMPARATOR

3 times/week for 6 weeks

Other: isokinetic upper-limb training

Interventions

concentric training of the affected plantarflexors, hip flexors and hip extensors

isokinetic lower-limb training

concentric training of the affected wrist extensors, elbow flexors and shoulder flexors

isokinetic uppe-limb training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de réadaptation Gingras-Lindsay

Montreal, Quebec, H3S 1M9, Canada

Location

MeSH Terms

Conditions

StrokeMotor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Study Officials

  • Sylvie Nadeau, PhD

    Université de Montréal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

March 15, 2013

First Posted

March 26, 2013

Study Start

March 1, 2002

Primary Completion

December 1, 2005

Study Completion

December 1, 2007

Last Updated

March 26, 2013

Record last verified: 2013-03

Locations