StrokeI-PICSNCT04650802
Improving Propulsion of the Paretic Leg In Chronic Stroke
A study testing Gait training in people with Stroke, run by Sint Maartenskliniek at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Gait training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteNetherlands
- Study dates
- 4 Mar 2019to 11 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Gait training
- Keywords
- Gait, Rehabilitation, Robotics, Propulsion, Speed, Biomechanics
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait trainingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Gait training | Experimental | 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. Receives: Device: Gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 (11)
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
Change in performance on the Six-minute walk test between pre- and post-intervention
Six-minute walk test (meters) was performed.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: Assessments are performed five weeks (T0) before the start of the intervention.
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.
Measured: Assessments are performed five weeks (T0) before the start of the intervention.
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.
Measured: Assessments are performed five weeks (T0) before the start of the intervention.
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.
Measured: Assessments are performed five weeks (T0) before the start of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start4 Mar 2019
- Primary completion11 Mar 2020
- Study completion11 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Longitudinal intervention study with two consecutive baseline assessments and a five-week follow-up
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sint Maartenskliniek
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center
- Responsible party
- Sponsor
- Investigators
- ACH Geurts, Prof. dr., Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650802
- Sponsor's protocol ID
- 785_LOPES I-PICS
- Other IDs
- R201605453
- Acronym
- I-PICS
- Status last verified
- Nov 2020
- First submitted
- 13 Nov 2020
- Last updated
- 3 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33892754
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Propulsion of the Paretic Leg In Chronic Stroke
- ClinicalTrials.gov ID
- NCT04650802
- Acronym / sponsor ID
- I-PICS / 785_LOPES I-PICS
- Conditions
- Stroke
- Keywords
- Gait, Rehabilitation, Robotics, Propulsion, Speed, Biomechanics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Sint MaartenskliniekUniversity, hospital or other
- Collaborators
- Radboud University Medical Center
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 11 Mar 2020 (actual)
- Study completion
- 11 Mar 2020 (actual)
- First posted
- 3 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Longitudinal intervention study with two consecutive baseline assessments and a five-week follow-up
| Arm | Type | Receives |
|---|---|---|
| Gait training | Experimental | Device: Gait trainingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gait trainingParticipants 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. | Device | Gait training |
Primary outcome
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.
Propulsion symmetry was calculated by dividing the paretic propulsive impulse by the sum of the paretic and non-paretic propulsive impulse
11 secondary outcomes
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.
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.
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.
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.
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.
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.
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.
Static postural balance at baseline
Time frame: Assessments are performed five weeks (T0) before the start of the intervention.
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.
Maximal ankle plantarflexion moment at baseline
Time frame: Assessments are performed five weeks (T0) before the start of the intervention.
Score on the maximal steplength test at baseline
Time frame: Assessments are performed five weeks (T0) before the start of the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Derived from this study: PubMed 33892754Alingh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ACH Geurts, Prof. dr. principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait training in people with Stroke, run by Sint Maartenskliniek at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04650802, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2020.