Clinical trial NCT02113098: Effects of Treadmill Gait Training With Loading in Individuals With Stroke
Official title: Effects of Treadmill Gait Training With Adding Load on Lower Limb of Individuals With Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Gait Disorders, Neurologic
Keywords: Stroke
Gait
Rehabilitation
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
First posted: 2014-04-14
Enrollment: 38
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ground reaction force, in Newtons
timeFrame: Until one year after stroke
measure: Angular displacements of hip, knee and ankle (in degrees)
timeFrame: Until one year after stroke
measure: Symmetry ratio (swing time of paretic limb/swing time of non-paretic limb)
timeFrame: Until one year after stroke
Secondary outcomes:
measure: speed (meters/second)
timeFrame: Until one year after stroke
measure: double support time (in seconds)
timeFrame: Until one year after stroke
measure: step length (in meters)
timeFrame: Until one year after stroke
measure: stride length (in meters)
timeFrame: Until one year after stroke
Other outcomes:
Locations:
city: Natal
country: Brazil
facility: Universidade Federal do Rio Grande do Norte
state: Rio Grande Do Norte
Study officials:
affiliation: Universidade Federal do Rio Grande do Norte
name: Tatiana S Ribeiro, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: E Silva EMGS, Ribeiro TS, da Silva TCC, Costa MFP, Cavalcanti FADC, Lindquist ARR. Effects of constraint-induced movement therapy for lower limbs on measurements of functional mobility and postural balance in subjects with stroke: a randomized controlled trial. Top Stroke Rehabil. 2017 Dec;24(8):555-561. doi: 10.1080/10749357.2017.1366011. Epub 2017 Aug 31.