Movement Analysis of Stroke Patients When Walking on a Treadmill

Stroke Clinical Trial

Official title:

Movement Analysis of Stroke Patients When Walking on a Treadmill

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04180124
• Other study ID #: 2019-1349
• Status: Completed
• Phase: N/A
• Start date: January 6, 2020
• Est. completion date: September 15, 2020

Study information

• Verified date: January 2020
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 15, 2020
• Est. primary completion date: September 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Walking
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.

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
University Ghent	University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographic variables	gender, age, stroke type, stroke date, hemiparetic side, use of walking aids for outdoor walking	Before walking trials
Primary	Change in kinematics	Change in full body 3D kinematic analyses during walking (°)	Single point of assessment in one day
Primary	Change in kinetics	Change in full body 3D kinetic analyses during walking	Single point of assessment in one day
Secondary	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
Secondary	Postural stability test	Balance test	Baseline assessment before walking trials
Secondary	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
Secondary	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
Secondary	Lateral rotation of the scapula	Lateral rotation of the scapula measured with an inclinometer (°)	Baseline assessment before walking trials