Clinical trial NCT04650802: Improving Propulsion of the Paretic Leg In Chronic Stroke
Official title: Improving Propulsion of the Paretic Leg In Chronic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Gait
Rehabilitation
Robotics
Propulsion
Speed
Biomechanics
Lead sponsor: Sint Maartenskliniek
Sponsor class: OTHER
Collaborators: name: Radboud University Medical Center
First posted: 2020-12-03
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Longitudinal intervention study with two consecutive baseline assessments and a five-week follow-up
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* adults (\>18 years of age) with unilateral ischemic or heamorrhagic supratentorial stroke
* at least 6 months post-onset
* impaired propulsion of the paretic leg during walking at a self-selected speed (≥ 8 percent propulsion asymmetry)
* ability to walk 10 meter without support or use of a walking aid (Functional Ambulatory Categories (FAC) 3-5)
* ability to walk for 5 consecutive minutes, with or without the use of a walking aid
* at least 10 degrees passive hip extension and able to stand plantigrade with extended knee

Exclusion Criteria:

* inability to move the body upward against gravity (calf muscle - Medical Research Council (MRC) scale \< 3)
* severe cognitive problems assessed with Mini-Mental State Examination (MMSE \< 24)
* depressed mood assessed with the Hospital Anxiety and Depression Score (HADS \> 7)
* persistent unilateral visuospatial neglect assessed with the Star Cancellation Test (score \< 44)
* any medical condition interfering with gait
* inability to understand verbal instructions
* inappropriate or unsafe fitting of the robotic gait trainer, due to severe lower limb spasticity (Modified Ashworth Scale (MAS) ≥ 3), severe lower limb contractures, body weight ≥ 140 kg, or skin problems at body sites where the harness or straps were to be fitted

Primary outcomes:
measure: Change in propulsion symmetry at self-selected gait speed between pre- and post-intervention
timeFrame: 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.
Secondary outcomes:
measure: Change in self-selected gait speed between pre- and post-intervention
timeFrame: 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.
measure: Change in trailing limb angle of the paretic leg between pre- and post-intervention
timeFrame: 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.
measure: Change in ankle plantarflexion moment of the paretic leg between pre- and post-intervention
timeFrame: 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.
measure: Change in performance on the Six-minute walk test between pre- and post-intervention
timeFrame: 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.
measure: Change in performance on the Functional gait assessment between pre- and post-intervention
timeFrame: 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.
measure: Change in daily-life mobility between pre- and post-intervention
timeFrame: 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.
measure: Change in daily-life physical activity between pre- and post-intervention
timeFrame: 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.
measure: Static postural balance at baseline
timeFrame: Assessments are performed five weeks (T0) before the start of the intervention.
measure: The difference in propulsion impulse of the paretic leg during walking at fast vs. self-selected speed at baseline
timeFrame: Assessments are performed five weeks (T0) before the start of the intervention.
measure: Maximal ankle plantarflexion moment at baseline
timeFrame: Assessments are performed five weeks (T0) before the start of the intervention.
measure: Score on the maximal steplength test at baseline
timeFrame: Assessments are performed five weeks (T0) before the start of the intervention.
Other outcomes:
Locations:
city: Ubbergen
country: Netherlands
facility: Sint Maartenskliniek
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: ACH Geurts, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alingh JF, Groen BE, Kamphuis JF, Geurts ACH, Weerdesteyn V. Task-specific training for improving propulsion symmetry and gait speed in people in the chronic phase after stroke: a proof-of-concept study. J Neuroeng Rehabil. 2021 Apr 23;18(1):69. doi: 10.1186/s12984-021-00858-8.