NCT04180124

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 27, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

January 6, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2020

Completed
Last Updated

April 8, 2021

Status Verified

January 1, 2020

Enrollment Period

8 months

First QC Date

October 21, 2019

Last Update Submit

April 6, 2021

Conditions

Stroke

Keywords

Gait patternTreadmill walkingArm swing

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • Speed variability during self-paced treadmill walking

    Single point of assessment in one day

  • 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

  • Lateral rotation of the scapula

    Baseline assessment before walking trials

Other Outcomes (1)

  • Demographic variables

    Before walking trials

Study Arms (5)

GaitRite

EXPERIMENTAL

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

Treadmill walking self-paced

EXPERIMENTAL

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

Treadmill walking fixed speed - comfortable speed

EXPERIMENTAL

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

Treadmill walking fixed speed - fast speed

EXPERIMENTAL

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

Treadmill walking fixed speed - backward walking

EXPERIMENTAL

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

Interventions

WalkingOTHER

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.

GaitRiteTreadmill walking fixed speed - backward walkingTreadmill walking fixed speed - comfortable speedTreadmill walking fixed speed - fast speedTreadmill walking self-paced

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stroke patients with the ability to walk without walking devices for 6 minutes without rest (indoor walking). Use of AFO is allowed if necessary.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Stroke

Interventions

Walking

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2019

First Posted

November 27, 2019

Study Start

January 6, 2020

Primary Completion

September 15, 2020

Study Completion

September 15, 2020

Last Updated

April 8, 2021

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)