Effects of Treadmill Gait Training With Adding Load on Lower Limb of Individuals With Stroke
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Ground reaction force, in Newtons
Study Overview
Brief Summary
The purpose of this study is to determine whether the add load on non-paretic lower limb of individuals that suffer a stroke, while walking on a treadmill, is effective for restore gait symmetry of these individuals, in a subacute phase of stroke.
Detailed Description
This is a randomized and blinded clinical trial, in which participants are being randomly divided into experimental group and control group, in order to verify the effects of adding load on gait symmetry after stroke. 40 individuals will participate, and the calculation of sample size was performed from the ratio variable symmetry of swing time, based on previous study. Whereas about 15% of individuals could give up to participate in the study during their course (dropout rate), we determined a number of 20 participants in each group.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •First episode of stroke (ischemic or hemorrhagic) which determined unilateral hemiparesis
- •Time of lesion less one year
- •Able to walk independently by 10 feet on flat surface without the use of assistive devices
- •Gait speed less than 0.8 m / s
- •Ability to understand and obey simple commands
Exclusion Criteria
- •Instability of cardiac conditions
- •Adverse clinical conditions affecting balance and / or gait
- •Pain and / or severe discomfort that impede the realization of the proposed activities
- •Decompensation in systemic blood pressure, with the systolic and diastolic values above 200 mmHg and 110 mmHg, respectively, before and / or after training
- •Submaximal heart rate above the allowed values during training
Arms & Interventions
Treadmill, ankle load
The experimental group will perform gait training on a treadmill with added load to the non-paretic lower limb
Intervention: Treadmill, ankle load (Other)
Treadmill
The control group (active comparator) will perform gait training on a treadmill
Intervention: Treadmill (Other)
Outcomes
Primary Outcomes
Ground reaction force, in Newtons
Time Frame: Until one year after stroke
Vertical component of ground reaction force, measured using a force platform
Symmetry ratio (swing time of paretic limb/swing time of non-paretic limb)
Time Frame: Until one year after stroke
Spatiotemporal gait variable, measured by a system of movement analysis
Angular displacements of hip, knee and ankle (in degrees)
Time Frame: Until one year after stroke
Angular gait variables, measured by a system of movement analysis.
Secondary Outcomes
- speed (meters/second)(Until one year after stroke)
- stride length (in meters)(Until one year after stroke)
- double support time (in seconds)(Until one year after stroke)
- step length (in meters)(Until one year after stroke)
Investigators
Ana Raquel Rodrigues Lindquist, PhD
PhD
Universidade Federal do Rio Grande do Norte