Sint Maartenskliniek
Ubbergen, Gelderland, 6574NA, Netherlands
NCT Number: NCT04650802
Stroke survivors may have a latent, propulsive capacity of the paretic leg, that can be elicited during short, intensive gait training interventions. The aim of this study was therefor to investigate the effect of a five-week gait training on paretic propulsion, propulsion symmetry, gait capacity, and daily-life mobility and physical activity in chronic stroke survivors.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Ubbergen, Gelderland, 6574NA, Netherlands
Stroke survivors may have a latent, propulsive capacity of the paretic leg, that can be elicited during short, intensive gait training interventions. The aim of this study was therefor to investigate the effect of a five-week gait training on paretic propulsion, propulsion symmetry, gait capacity, and daily-life mobility and physical activity in chronic stroke survivors. We hypothesize that the robotic gait training will improve propulsion symmetry and, thereby, gait speed and functional gait tasks. In addition, we expect that improved gait capacity might lead to less impact of stroke on daily-life mobility and a higher physical activity level. Thirty-three chronic stroke survivors with impaired paretic propulsion (≥8% difference in paretic vs. non-paretic propulsive impulse) will be enrolled in this proof-of-concept study. Participants receive five weeks individual robotic gait training targeting paretic propulsion (60 minutes, two time a week). The robotic gait training is complemented with daily home exercises (15 minutes/day) focusing on increasing strength and practice of learned strategies in daily life. Propulsion measures, self-selected gait speed, performance on functional gait tasks, and daily-life mobility and physical activity are assessed five weeks (T0) and one week (T1) before the start of the intervention, and one week (T2) and five weeks (T3) after the end of the intervention.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants receive five weeks individual robotic gait training in LOPES II, targeting paretic propulsion (60 minutes, two time a week). The robotic gait training is complemented with daily home exercises (15 minutes/day) focusing on increasing strength and practice of learned strategies in daily life.
Time frame: Assessments are performed five weeks (T0) and one week (T1) before the start of the intervention, and one week (T2) and five weeks (T3) after the end of the five-week intervention period.
Propulsion symmetry was calculated by dividing the paretic propulsive impulse by the sum of the paretic and non-paretic propulsive impulse
Time frame: Assessments are performed five weeks (T0) and one week (T1) before the start of the intervention, and one week (T2) and five weeks (T3) after the end of the five-week intervention period.
Participants walked at their self-selected, comfortable speed along a straight six-meter walkway. Gait speed was determined in m/s.
Time frame: Assessments are performed five weeks (T0) and one week (T1) before the start of the intervention, and one week (T2) and five weeks (T3) after the end of the five-week intervention period.
The position of the hip joint center and toe marker, determined with a 3D gait analysis, were used to calculate the trailing limb angle (in degrees) of the paretic leg at the instant of peak paretic anterior ground reaction force.
Time frame: Assessments are performed five weeks (T0) and one week (T1) before the start of the intervention, and one week (T2) and five weeks (T3) after the end of the five-week intervention period.
Vicon Plug-In-Gait model and software were used to calculate paretic ankle plantarflexion moment (Nm/kg) at the instant of peak paretic anterior ground reaction force.
Time frame: Assessments are performed five weeks (T0) and one week (T1) before the start of the intervention, and one week (T2) and five weeks (T3) after the end of the five-week intervention period.
Six-minute walk test (meters) was performed.
Time frame: Assessments are performed five weeks (T0) and one week (T1) before the start of the intervention, and one week (T2) and five weeks (T3) after the end of the five-week intervention period.
Functional gait assessment (score range 0-30) was performed. Higher scores indicate better outcome.
Time frame: Assessments are performed five weeks (T0) and one week (T1) before the start of the intervention, and one week (T2) and five weeks (T3) after the end of the five-week intervention period.
Daily-life mobility was assessed with the Stroke Impact Scale (SIS - domain Mobility, range 0-100). Higher scores indicate better outcome.
Time frame: Assessments are performed five weeks (T0) and one week (T1) before the start of the intervention, and one week (T2) and five weeks (T3) after the end of the five-week intervention period.
Daily-life physical activity was assesed using an activity-tracker (Activ8). Participants wore the activity tracker for 24 hours a day, for a minimum of five consecutive days. Total time of walking and the intensity of walking were determined.
Time frame: Assessments are performed five weeks (T0) before the start of the intervention.
To determine the association between individuals' baseline characteristics and the training response the determinant was assessed during stance using forceplates at T0.
Time frame: Assessments are performed five weeks (T0) before the start of the intervention.
To determine the association between individuals' baseline characteristics and the training response the determinant was assessed during the 3D-gait analysis at T0.
Time frame: Assessments are performed five weeks (T0) before the start of the intervention.
To determine the association between individuals' baseline characteristics and the training response the determinant was assessed with the Biodex at T0.
Time frame: Assessments are performed five weeks (T0) before the start of the intervention.
To determine the association between individuals' baseline characteristics and the training response the determinant was assessed at T0.
Sint Maartenskliniek
Other
Acronym: I-PICS
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