Clinical trial NCT04180124: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Gait pattern
Treadmill walking
Arm swing
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: University Hospital, Ghent
First posted: 2019-11-27
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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


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

Primary outcomes:
measure: Change in kinematics
timeFrame: Single point of assessment in one day
measure: Change in kinetics
timeFrame: Single point of assessment in one day
Secondary outcomes:
measure: Speed variability during self-paced treadmill walking
timeFrame: Single point of assessment in one day
measure: Postural stability test
timeFrame: Baseline assessment before walking trials
measure: Fugl Meyer assessment UL
timeFrame: Baseline assessment before walking trials
measure: Fugl Meyer assessment LL
timeFrame: Baseline assessment before walking trials
measure: Lateral rotation of the scapula
timeFrame: Baseline assessment before walking trials
Other outcomes:
measure: Demographic variables
timeFrame: Before walking trials
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
References: