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Improving Propulsion of the Paretic Leg In Chronic Stroke (I-PICS)

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Gait training
Sponsored by
Sint Maartenskliniek
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Gait, Rehabilitation, Robotics, Propulsion, Speed, Biomechanics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sint Maartenskliniek

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gait training

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
Change in performance on the Six-minute walk test between pre- and post-intervention
Six-minute walk test (meters) was performed.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
November 13, 2020
Last Updated
November 24, 2020
Sponsor
Sint Maartenskliniek
Collaborators
Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04650802
Brief Title
Improving Propulsion of the Paretic Leg In Chronic Stroke
Acronym
I-PICS
Official Title
Improving Propulsion of the Paretic Leg In Chronic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
March 4, 2019 (Actual)
Primary Completion Date
March 11, 2020 (Actual)
Study Completion Date
March 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sint Maartenskliniek
Collaborators
Radboud University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Gait, Rehabilitation, Robotics, Propulsion, Speed, Biomechanics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Longitudinal intervention study with two consecutive baseline assessments and a five-week follow-up
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gait training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Gait training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in propulsion symmetry at self-selected gait speed between pre- and post-intervention
Description
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.
Secondary Outcome Measure Information:
Title
Change in self-selected gait speed between pre- and post-intervention
Description
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.
Title
Change in trailing limb angle of the paretic leg between pre- and post-intervention
Description
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.
Title
Change in ankle plantarflexion moment of the paretic leg between pre- and post-intervention
Description
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.
Title
Change in performance on the Six-minute walk test between pre- and post-intervention
Description
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.
Title
Change in performance on the Functional gait assessment between pre- and post-intervention
Description
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.
Title
Change in daily-life mobility between pre- and post-intervention
Description
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.
Title
Change in daily-life physical activity between pre- and post-intervention
Description
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) 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.
Title
Static postural balance at baseline
Description
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.
Title
The difference in propulsion impulse of the paretic leg during walking at fast vs. self-selected speed at baseline
Description
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.
Title
Maximal ankle plantarflexion moment at baseline
Description
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.
Title
Score on the maximal steplength test at baseline
Description
To determine the association between individuals' baseline characteristics and the training response the determinant was assessed at T0.
Time Frame
Assessments are performed five weeks (T0) before the start of the intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ACH Geurts, Prof. dr.
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sint Maartenskliniek
City
Ubbergen
State/Province
Gelderland
ZIP/Postal Code
6574NA
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33892754
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.
Results Reference
derived

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Improving Propulsion of the Paretic Leg In Chronic Stroke

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