Gait Disorders, Neurologic, Stroke
Conditions
Keywords
Stroke, Gait, Rehabilitation
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.
Interventions
OTHERTreadmill, ankle load
The experimental group will perform gait training on a treadmill (Gait Trainer 2®) with added load to the ankle of the non-paretic lower limb, plus physical therapy correction for restore gait symmetry. The intervention will last 30 minutes, in nine sessions for two weeks
OTHERTreadmill
The control group (active comparator) will perform gait training on a treadmill (Gait Trainer 2®) with physical therapy correction for restore gait symmetry. The intervention will last 30 minutes, in nine sessions for two weeks
Sponsors
Universidade Federal do Rio Grande do Norte
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ground reaction force, in Newtons | Until one year after stroke | Vertical component of ground reaction force, measured using a force platform |
| Angular displacements of hip, knee and ankle (in degrees) | Until one year after stroke | Angular gait variables, measured by a system of movement analysis. |
| Symmetry ratio (swing time of paretic limb/swing time of non-paretic limb) | Until one year after stroke | Spatiotemporal gait variable, measured by a system of movement analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| speed (meters/second) | Until one year after stroke | Spatiotemporal gait variable, measured by a system of movement analysis |
| stride length (in meters) | Until one year after stroke | Spatiotemporal gait variable, measured by a system of movement analysis |
| double support time (in seconds) | Until one year after stroke | Spatiotemporal gait variable, measured by a system of movement analysis |
| step length (in meters) | Until one year after stroke | Spatiotemporal gait variable, measured by a system of movement analysis |
Countries
Brazil
Outcome results
None listed