- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04650802
Improving Propulsion of the Paretic Leg In Chronic Stroke (I-PICS)
November 24, 2020 updated by: Sint Maartenskliniek
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Gelderland
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Ubbergen, Gelderland, Netherlands, 6574NA
- Sint Maartenskliniek
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in propulsion symmetry at self-selected gait speed between pre- and post-intervention
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.
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Propulsion symmetry was calculated by dividing the paretic propulsive impulse by the sum of the paretic and non-paretic propulsive impulse
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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in self-selected gait speed between pre- and post-intervention
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.
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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.
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Change in trailing limb angle of the paretic leg between pre- and post-intervention
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.
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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.
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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.
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Change in ankle plantarflexion moment of the paretic leg between pre- and post-intervention
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.
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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.
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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.
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Change in performance on the Six-minute walk test between pre- and post-intervention
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.
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Six-minute walk test (meters) was performed.
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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.
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Change in performance on the Functional gait assessment between pre- and post-intervention
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.
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Functional gait assessment (score range 0-30) was performed.
Higher scores indicate better outcome.
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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.
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Change in daily-life mobility between pre- and post-intervention
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.
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Daily-life mobility was assessed with the Stroke Impact Scale (SIS - domain Mobility, range 0-100).
Higher scores indicate better outcome.
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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.
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Change in daily-life physical activity between pre- and post-intervention
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.
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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.
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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.
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Static postural balance at baseline
Time Frame: Assessments are performed five weeks (T0) before the start of the intervention.
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To determine the association between individuals' baseline characteristics and the training response the determinant was assessed during stance using forceplates at T0.
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Assessments are performed five weeks (T0) before the start of the intervention.
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The difference in propulsion impulse of the paretic leg during walking at fast vs. self-selected speed at baseline
Time Frame: Assessments are performed five weeks (T0) before the start of the intervention.
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To determine the association between individuals' baseline characteristics and the training response the determinant was assessed during the 3D-gait analysis at T0.
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Assessments are performed five weeks (T0) before the start of the intervention.
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Maximal ankle plantarflexion moment at baseline
Time Frame: Assessments are performed five weeks (T0) before the start of the intervention.
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To determine the association between individuals' baseline characteristics and the training response the determinant was assessed with the Biodex at T0.
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Assessments are performed five weeks (T0) before the start of the intervention.
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Score on the maximal steplength test at baseline
Time Frame: Assessments are performed five weeks (T0) before the start of the intervention.
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To determine the association between individuals' baseline characteristics and the training response the determinant was assessed at T0.
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Assessments are performed five weeks (T0) before the start of the intervention.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: ACH Geurts, Prof. dr., Radboud University Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 4, 2019
Primary Completion (ACTUAL)
March 11, 2020
Study Completion (ACTUAL)
March 11, 2020
Study Registration Dates
First Submitted
November 13, 2020
First Submitted That Met QC Criteria
November 24, 2020
First Posted (ACTUAL)
December 3, 2020
Study Record Updates
Last Update Posted (ACTUAL)
December 3, 2020
Last Update Submitted That Met QC Criteria
November 24, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 785_LOPES I-PICS
- R201605453 (OTHER_GRANT: Revalidatiefonds)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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