Improving Propulsion of the Paretic Leg In Chronic Stroke

Stroke Clinical Trial

— I-PICS  

Official title:

Improving Propulsion of the Paretic Leg In Chronic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04650802
• Other study ID #: 785_LOPES I-PICS
• Secondary ID: R201605453
• Status: Completed
• Phase: N/A
• Start date: March 4, 2019
• Est. completion date: March 11, 2020

Study information

• Verified date: November 2020
• Source: Sint Maartenskliniek
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: March 11, 2020
• Est. primary completion date: March 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Gait training
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.

Locations

Country	Name	City	State
Netherlands	Sint Maartenskliniek	Ubbergen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Sint Maartenskliniek	Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in propulsion symmetry at self-selected gait speed between pre- and post-intervention	Propulsion symmetry was calculated by dividing the paretic propulsive impulse by the sum of the paretic and non-paretic propulsive impulse	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	Change in self-selected gait speed between pre- and post-intervention	Participants walked at their self-selected, comfortable speed along a straight six-meter walkway. Gait speed was determined in m/s.	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	Change in trailing limb angle of the paretic leg between pre- and post-intervention	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.	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	Change in ankle plantarflexion moment of the paretic leg between pre- and post-intervention	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.	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	Change in performance on the Six-minute walk test between pre- and post-intervention	Six-minute walk test (meters) was performed.	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	Change in performance on the Functional gait assessment between pre- and post-intervention	Functional gait assessment (score range 0-30) was performed. Higher scores indicate better outcome.	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	Change in daily-life mobility between pre- and post-intervention	Daily-life mobility was assessed with the Stroke Impact Scale (SIS - domain Mobility, range 0-100). Higher scores indicate better outcome.	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	Change in daily-life physical activity between pre- and post-intervention	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.	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	Static postural balance at baseline	To determine the association between individuals' baseline characteristics and the training response the determinant was assessed during stance using forceplates at T0.	Assessments are performed five weeks (T0) before the start of the intervention.
Secondary	The difference in propulsion impulse of the paretic leg during walking at fast vs. self-selected speed at baseline	To determine the association between individuals' baseline characteristics and the training response the determinant was assessed during the 3D-gait analysis at T0.	Assessments are performed five weeks (T0) before the start of the intervention.
Secondary	Maximal ankle plantarflexion moment at baseline	To determine the association between individuals' baseline characteristics and the training response the determinant was assessed with the Biodex at T0.	Assessments are performed five weeks (T0) before the start of the intervention.
Secondary	Score on the maximal steplength test at baseline	To determine the association between individuals' baseline characteristics and the training response the determinant was assessed at T0.	Assessments are performed five weeks (T0) before the start of the intervention.