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Movement Analysis of Stroke Patients When Walking on a Treadmill

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Walking
Sponsored by
University Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Stroke focused on measuring Gait pattern, Treadmill walking, Arm swing

Eligibility Criteria

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

Inclusion Criteria:

  • Stroke patients with the ability to walk without walking devices for 6 minutes without rest (indoor walking). Use of AFO is allowed if necessary.

Exclusion Criteria:

  • Traumatic brain lesions (car accident, fall with bike, …)
  • Other disorders such as neurologic, musculoskeletal, respiratory or severe cardiovascular disorders that affected gait performance

    • Bilateral stroke
    • Cerebellar stroke
    • Orthopedic surgery lower limbs in the past
    • Cognitive or language impairments that prevent the patients from understand simple orders

Sites / Locations

  • Ghent University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

GaitRite

Treadmill walking self-paced

Treadmill walking fixed speed - comfortable speed

Treadmill walking fixed speed - fast speed

Treadmill walking fixed speed - backward walking

Arm Description

Patients will walk on the GaitRite. forward walking at comfortable gait speed (6 x 10 meter) backward walking at comfortable gait speed (4 x 10 meter)

Patients will walk on the treadmill in self-paced mode. They can control walking speed by themselves. Patient walks for 3 minutes for every condition = data will be recorded for 1 minute.

Patients will walk on the treadmill in fixed speed mode. They will walk at comfortable gait speed, which is determined in the familiarization period. Patient walks for 3 minutes for every condition = data will be recorded for 1 minute.

Patients will walk on the treadmill in fixed speed mode. They will walk at a gait speed, which is 1 minimal clinical difference faster than their comfortable gait speed. Patient walks for 3 minutes for every condition = data will be recorded for 1 minute.

Patients will walk on the treadmill in fixed speed mode. Patient will walk backwards on the treadmill if they are able to. Patient walks for 3 minutes for every condition = data will be recorded for 1 minute.

Outcomes

Primary Outcome Measures

Change in kinematics
Change in full body 3D kinematic analyses during walking (°)
Change in kinetics
Change in full body 3D kinetic analyses during walking

Secondary Outcome Measures

Speed variability during self-paced treadmill walking
Average walking speed (and standard deviation) during self-paced treadmill walking
Postural stability test
Balance test
Fugl Meyer assessment UL
Impairment test for upper extremity in stroke patients: Fugl Meyer assessment - score between 0 and 66. Higher score reflects less impairment of the upper limb.
Fugl Meyer assessment LL
Impairment test for lower extremity in stroke patients: Fugl Meyer assessment lower extremity. Scores between 0 - 34. Higher score reflects less impairment of the lower limb.
Lateral rotation of the scapula
Lateral rotation of the scapula measured with an inclinometer (°)

Full Information

First Posted
October 21, 2019
Last Updated
April 6, 2021
Sponsor
University Ghent
Collaborators
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT04180124
Brief Title
Movement Analysis of Stroke Patients When Walking on a Treadmill
Official Title
Movement Analysis of Stroke Patients When Walking on a Treadmill
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 6, 2020 (Actual)
Primary Completion Date
September 15, 2020 (Actual)
Study Completion Date
September 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent
Collaborators
University Hospital, Ghent

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
In daily clinic, the use of treadmills to analyze the gait quality of a patient increases. The advantages of using a treadmill are that a smaller space is needed compared to a 3D lab for motion analysis, more steps can be recorded in shorter time period and patients should not start, stop or rotate during the analyses. One of the systems which can be used to perform motion analysis on a treadmill is the GRAIL. This GRAIL (Gait Real-time Analysis Interactive Lab) consists of an advanced treadmill with force sensors. Patients can walk on this treadmill with an imposed speed (fixed-speed) or at a speed determined by the patient itself (self-paced). Because not everyone is used to walk on a treadmill it is important to know if a person's walking pattern is different when he walks over ground compared to walking on the treadmill. Based on these insights, decisions can be made regarding interventions including treadmill training or this findings can be taking into account during further analysis of walking patterns on a treadmill. For this study stroke patients would be invited for an assessment on the treadmill (1 assessment moment). The movement pattern of these patients would be compared in different conditions: (Forward and backward) Walking at comfortable walking speed on the GAITRite Walking at comfortable walking speed on the treadmill in fixed speed mode Walking at comfortable walking speed +0.2 m/s (faster walking) on the treadmill in fixed speed mode Walking at comfortable walking speed on the treadmill in self-paced mode Backward walking at comfortable walking speed on the treadmill in fixed speed mode (only if patients are eligible to do so) Hypotheses based on this study protocol: Do stroke patients walk different over ground compared to treadmill walking Do stroke patients walk different during treadmill walking self-paced compared to fixed speed Do stroke patients walk different during treadmill walking fixed speed comfortable walking speed compared to fast walking Is there a correlation between upper extremity impairment and arm swing

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Gait pattern, Treadmill walking, Arm swing

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GaitRite
Arm Type
Experimental
Arm Description
Patients will walk on the GaitRite. forward walking at comfortable gait speed (6 x 10 meter) backward walking at comfortable gait speed (4 x 10 meter)
Arm Title
Treadmill walking self-paced
Arm Type
Experimental
Arm Description
Patients will walk on the treadmill in self-paced mode. They can control walking speed by themselves. Patient walks for 3 minutes for every condition = data will be recorded for 1 minute.
Arm Title
Treadmill walking fixed speed - comfortable speed
Arm Type
Experimental
Arm Description
Patients will walk on the treadmill in fixed speed mode. They will walk at comfortable gait speed, which is determined in the familiarization period. Patient walks for 3 minutes for every condition = data will be recorded for 1 minute.
Arm Title
Treadmill walking fixed speed - fast speed
Arm Type
Experimental
Arm Description
Patients will walk on the treadmill in fixed speed mode. They will walk at a gait speed, which is 1 minimal clinical difference faster than their comfortable gait speed. Patient walks for 3 minutes for every condition = data will be recorded for 1 minute.
Arm Title
Treadmill walking fixed speed - backward walking
Arm Type
Experimental
Arm Description
Patients will walk on the treadmill in fixed speed mode. Patient will walk backwards on the treadmill if they are able to. Patient walks for 3 minutes for every condition = data will be recorded for 1 minute.
Intervention Type
Other
Intervention Name(s)
Walking
Intervention Description
Patients walk over ground on a mat with sensors and on a treadmill with sensors (in different conditions) to compare their movement pattern. Also the movement pattern will be compared between walking at comfortable walking speed en fast walking. Finally, the correlation between upper extremity impairment and arm swing will be investigated.
Primary Outcome Measure Information:
Title
Change in kinematics
Description
Change in full body 3D kinematic analyses during walking (°)
Time Frame
Single point of assessment in one day
Title
Change in kinetics
Description
Change in full body 3D kinetic analyses during walking
Time Frame
Single point of assessment in one day
Secondary Outcome Measure Information:
Title
Speed variability during self-paced treadmill walking
Description
Average walking speed (and standard deviation) during self-paced treadmill walking
Time Frame
Single point of assessment in one day
Title
Postural stability test
Description
Balance test
Time Frame
Baseline assessment before walking trials
Title
Fugl Meyer assessment UL
Description
Impairment test for upper extremity in stroke patients: Fugl Meyer assessment - score between 0 and 66. Higher score reflects less impairment of the upper limb.
Time Frame
Baseline assessment before walking trials
Title
Fugl Meyer assessment LL
Description
Impairment test for lower extremity in stroke patients: Fugl Meyer assessment lower extremity. Scores between 0 - 34. Higher score reflects less impairment of the lower limb.
Time Frame
Baseline assessment before walking trials
Title
Lateral rotation of the scapula
Description
Lateral rotation of the scapula measured with an inclinometer (°)
Time Frame
Baseline assessment before walking trials
Other Pre-specified Outcome Measures:
Title
Demographic variables
Description
gender, age, stroke type, stroke date, hemiparetic side, use of walking aids for outdoor walking
Time Frame
Before walking trials

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stroke patients with the ability to walk without walking devices for 6 minutes without rest (indoor walking). Use of AFO is allowed if necessary. Exclusion Criteria: Traumatic brain lesions (car accident, fall with bike, …) Other disorders such as neurologic, musculoskeletal, respiratory or severe cardiovascular disorders that affected gait performance Bilateral stroke Cerebellar stroke Orthopedic surgery lower limbs in the past Cognitive or language impairments that prevent the patients from understand simple orders
Facility Information:
Facility Name
Ghent University Hospital
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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Movement Analysis of Stroke Patients When Walking on a Treadmill

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