Impact of Training on Gait and Strength in Stroke Survivors

Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01818349
• Other study ID #: IRSC-44059
• Status: Completed
• Phase: N/A
• First received: March 15, 2013
• Last updated: March 21, 2013
• Start date: March 2002
• Est. completion date: December 2007

Study information

• Verified date: March 2013
• Source: Université de Montréal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2007
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• isokinetic lower-limb training
concentric training of the affected plantarflexors, hip flexors and hip extensors
• isokinetic upper-limb training
concentric training of the affected wrist extensors, elbow flexors and shoulder flexors

Locations

Country	Name	City	State
Canada	Institut de réadaptation Gingras-Lindsay	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Université de Montréal	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Secondary	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.	maximal voluntary concentric strength was assessed at baseline and at the completion of the 6-week training (i.e. week #7)	No