Movement Analysis of Stroke Patients When Walking on a Treadmill

Study Overview
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Brief Summary
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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

Official Title
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Movement Analysis of Stroke Patients When Walking on a Treadmill

Conditions
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Stroke

Intervention / Treatment
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* Other: Walking


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GaitRite<br>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) | Other: Walking<br>* 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.<br>|
| Experimental: Treadmill walking self-paced<br>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. | Other: Walking<br>* 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.<br>|
| Experimental: Treadmill walking fixed speed - comfortable speed<br>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. | Other: Walking<br>* 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.<br>|
| Experimental: Treadmill walking fixed speed - fast speed<br>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. | Other: Walking<br>* 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.<br>|
| Experimental: Treadmill walking fixed speed - backward walking<br>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. | Other: Walking<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in kinematics | Change in full body 3D kinematic analyses during walking (°) | Single point of assessment in one day | 
| Change in kinetics | Change in full body 3D kinetic analyses during walking | Single point of assessment in one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speed variability during self-paced treadmill walking | Average walking speed (and standard deviation) during self-paced treadmill walking | Single point of assessment in one day | 
| Postural stability test | Balance test | Baseline assessment before walking trials | 
| 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. | Baseline assessment before walking trials | 
| 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. | Baseline assessment before walking trials | 
| Lateral rotation of the scapula | Lateral rotation of the scapula measured with an inclinometer (°) | Baseline assessment before walking trials | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gait pattern, Treadmill walking, Arm swing