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Clinical Trials/NCT04180124
NCT04180124
Completed
N/A

Movement Analysis of Stroke Patients When Walking on a Treadmill

University Ghent1 site in 1 country25 target enrollmentJanuary 6, 2020
ConditionsStroke

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
University Ghent
Enrollment
25
Locations
1
Primary Endpoint
Change in kinematics
Status
Completed
Last Updated
5 years ago

Overview

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
Registry
clinicaltrials.gov
Start Date
January 6, 2020
End Date
September 15, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Change in kinematics

Time Frame: Single point of assessment in one day

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

Change in kinetics

Time Frame: Single point of assessment in one day

Change in full body 3D kinetic analyses during walking

Secondary Outcomes

  • Postural stability test(Baseline assessment before walking trials)
  • Fugl Meyer assessment UL(Baseline assessment before walking trials)
  • Fugl Meyer assessment LL(Baseline assessment before walking trials)
  • Speed variability during self-paced treadmill walking(Single point of assessment in one day)
  • Lateral rotation of the scapula(Baseline assessment before walking trials)

Study Sites (1)

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