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Completed

NCT Number: NCT04180124

Movement Analysis of Stroke Patients When Walking on a Treadmill

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

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University Hospital

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

walking

Other

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 outcomes

  1. Change in kinematics

    Time frame: Single point of assessment in one day

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

  2. Change in kinetics

    Time frame: Single point of assessment in one day

    Change in full body 3D kinetic analyses during walking

Secondary outcomes

  1. Speed variability during self-paced treadmill walking

    Time frame: Single point of assessment in one day

    Average walking speed (and standard deviation) during self-paced treadmill walking

  2. Postural stability test

    Time frame: Baseline assessment before walking trials

    Balance test

  3. Fugl Meyer assessment UL

    Time frame: Baseline assessment before walking trials

    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.

  4. Fugl Meyer assessment LL

    Time frame: Baseline assessment before walking trials

    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.

  5. Lateral rotation of the scapula

    Time frame: Baseline assessment before walking trials

    Lateral rotation of the scapula measured with an inclinometer (°)

Other outcomes

  1. Demographic variables

    Time frame: Before walking trials

    gender, age, stroke type, stroke date, hemiparetic side, use of walking aids for outdoor walking

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Collaborators

  • University Hospital, Ghent

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 27, 2019
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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