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Gait Adaptability Training, Using Augmented Reality, for Individuals in the Chronic Phase After Stroke (ATTAINS)

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Gait adaptability training
Sponsored by
Sint Maartenskliniek
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: > 6 months after first unilateral supratentorial stroke (chronic phase) Able to walk at least 10 minutes independently Exclusion Criteria: Any other neurological or musculoskeletal disease affecting gait or balance (e.g. Parkinson's disease, knee osteoarthritis) Contractures or spasticity requiring other treatment (e.g. botulinum toxin treatment) within the duration of the training period. Has received multiple training sessions on C-Mill or GRAIL in the past 12 months Severe cognitive or visuo-spatial impairments limiting comprehension of instructions or correct perception of the environments

Sites / Locations

  • Sint MaartenskliniekRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Training group

Waitlist control group

Arm Description

Patients assigned to the training group will receive a training targeting on gait adaptability using the C-mill. Subjects are asked to stop any other physical therapy program targeting gait, balance or leg function during the training period. Assessments will take place pre- and post-intervention

Patients assigned to the waitlist control group will receive standard care for 5 weeks whereafter they will receive the same training as the training group. Assessments will take place pre-intervention, post-waiting period and post-intervention.

Outcomes

Primary Outcome Measures

Walking Adaptability Ladder Test (WALT) score
Measure of gait adaptability. An adapted version for adults of the Walking Adaptability Laddertest for Kids (WAL-K) to assess the ability to flexibly adjust the gait pattern during overground walking. Outcome is based on performance time and foot placement errors measured in seconds where a lower score is a better outcome.
Emory Functional Ambulation Profile (EFAP) score
Measure of gait adaptability. In this task the participants traverse a standardized 5m obstacle course. Outcome is time to perform the task measured in seconds where a lower score is a better outcome.

Secondary Outcome Measures

Lab-based walking adaptability test
Measure of gait adaptability. Target stepping task using the Gait Real-time Analysis Interactive Lab (GRAIL) where participant must step on projected stepping stones as accurately as possible. Step width and step length between the stepping stones will vary.
Balance performance
Measure of gait stability, measured by the margin of stability (meter) and the center of mass excursion (meter), on treadmill walking with perturbations using the Gait Real-time Analysis Interactive Lab (GRAIL).
Balance performance through MiniBESTest
Measure of balance and gait stability using the Mini Balance Evaluation Systems Test (MiniBESTes). Tasks are scored on a 3-point scale. Outcome is an average score ranging between 0 and 1 where a higher score is a better outcome.
Walking performance
Measure of walking ability using the 10meter walktest, measured in seconds where a lower score is a better outcome
Balance confidence
Evaluating balance confidence using the Activity Balance Scale, measured on a 0% - 100% scale, where a higher score is a better outcome
Daily life gait performance as assessed by gait quality
Measured by inertial measurement units placed on both feet and the lower back. Analysis through cusomized algorythms.
Daily life walking activity assessed by walking time per day
Average time of walking during the day (minutes) measured in one week using the Activ8.
Health-related quality of life
Evaluating the disability and health-related quality of life after stroke using the Stroke Impact Scale mobility subscale, measure on a 5-point scale ("could not do at all = 1" - "not difficult at all = 5") where a higher score is a better outcome

Full Information

First Posted
February 7, 2023
Last Updated
April 11, 2023
Sponsor
Sint Maartenskliniek
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05827380
Brief Title
Gait Adaptability Training, Using Augmented Reality, for Individuals in the Chronic Phase After Stroke
Acronym
ATTAINS
Official Title
Adaptability Training for Individuals After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sint Maartenskliniek
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Background: The majority of stroke survivors regain walking ability, however the ability to adapt their gait to meet environmental demands remains impaired. This impaired gait adaptability has a profound impact on activities of daily living and quality of life. Treatment targeting these gait deficiencies is, therefore, critical for allowing safe and independent community ambulation in people with stroke. Rehabilitation programs targeting gait adaptability have gained interest in clinical practice. Besides, the use of augmented and virtual reality in rehabilitation programs becomes more common. Concerning gait adaptability, training programs are developed using the Cmill, an instrumented treadmill with augmented reality. Even though the efficacy of these interventions is limited to small, pilot trials, results are promising. Based on these results we hypothesize that a gait training program using the Cmill will improve gait adaptability and daily-life gait performance in people in the chronic phase after stroke. Objective: The primary objective of this study is to evaluate the efficacy of a gait training program using an instrumented treadmill with virtual and augmented reality for improving gait adaptability in people in the chronic phase after stroke. A second objective is to identify patient characteristics that predict a more favorable response to training. Study design: Randomized, waiting-list controlled trial to evaluate gait adaptability training Study population: 84 stroke patients in the chronic phase after stroke

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Training group
Arm Type
Experimental
Arm Description
Patients assigned to the training group will receive a training targeting on gait adaptability using the C-mill. Subjects are asked to stop any other physical therapy program targeting gait, balance or leg function during the training period. Assessments will take place pre- and post-intervention
Arm Title
Waitlist control group
Arm Type
No Intervention
Arm Description
Patients assigned to the waitlist control group will receive standard care for 5 weeks whereafter they will receive the same training as the training group. Assessments will take place pre-intervention, post-waiting period and post-intervention.
Intervention Type
Behavioral
Intervention Name(s)
Gait adaptability training
Intervention Description
During a period of approximately 5 weeks participants will receive 10 one hour training sessions aimed at improving gait adaptability, using the C-mill (an instrumented treadmill with augmented reality). Several aspects of gait adaptability, such as obstacle avoidance, accelerating/decelerating and precision stepping, will be offered.
Primary Outcome Measure Information:
Title
Walking Adaptability Ladder Test (WALT) score
Description
Measure of gait adaptability. An adapted version for adults of the Walking Adaptability Laddertest for Kids (WAL-K) to assess the ability to flexibly adjust the gait pattern during overground walking. Outcome is based on performance time and foot placement errors measured in seconds where a lower score is a better outcome.
Time Frame
Within 1 week post-intervention
Title
Emory Functional Ambulation Profile (EFAP) score
Description
Measure of gait adaptability. In this task the participants traverse a standardized 5m obstacle course. Outcome is time to perform the task measured in seconds where a lower score is a better outcome.
Time Frame
Within 1 week post-intervention
Secondary Outcome Measure Information:
Title
Lab-based walking adaptability test
Description
Measure of gait adaptability. Target stepping task using the Gait Real-time Analysis Interactive Lab (GRAIL) where participant must step on projected stepping stones as accurately as possible. Step width and step length between the stepping stones will vary.
Time Frame
Within 1 week post-intervention
Title
Balance performance
Description
Measure of gait stability, measured by the margin of stability (meter) and the center of mass excursion (meter), on treadmill walking with perturbations using the Gait Real-time Analysis Interactive Lab (GRAIL).
Time Frame
Within 1 week post-intervention
Title
Balance performance through MiniBESTest
Description
Measure of balance and gait stability using the Mini Balance Evaluation Systems Test (MiniBESTes). Tasks are scored on a 3-point scale. Outcome is an average score ranging between 0 and 1 where a higher score is a better outcome.
Time Frame
Within 1 week post-intervention
Title
Walking performance
Description
Measure of walking ability using the 10meter walktest, measured in seconds where a lower score is a better outcome
Time Frame
Within 1 week post-intervention
Title
Balance confidence
Description
Evaluating balance confidence using the Activity Balance Scale, measured on a 0% - 100% scale, where a higher score is a better outcome
Time Frame
Within 1 week post-intervention
Title
Daily life gait performance as assessed by gait quality
Description
Measured by inertial measurement units placed on both feet and the lower back. Analysis through cusomized algorythms.
Time Frame
Within 1 week post-intervention
Title
Daily life walking activity assessed by walking time per day
Description
Average time of walking during the day (minutes) measured in one week using the Activ8.
Time Frame
Within 1 week post-intervention
Title
Health-related quality of life
Description
Evaluating the disability and health-related quality of life after stroke using the Stroke Impact Scale mobility subscale, measure on a 5-point scale ("could not do at all = 1" - "not difficult at all = 5") where a higher score is a better outcome
Time Frame
Within 1 week post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: > 6 months after first unilateral supratentorial stroke (chronic phase) Able to walk at least 10 minutes independently Exclusion Criteria: Any other neurological or musculoskeletal disease affecting gait or balance (e.g. Parkinson's disease, knee osteoarthritis) Contractures or spasticity requiring other treatment (e.g. botulinum toxin treatment) within the duration of the training period. Has received multiple training sessions on C-Mill or GRAIL in the past 12 months Severe cognitive or visuo-spatial impairments limiting comprehension of instructions or correct perception of the environments
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marijne Nieuwelink, MSc
Phone
024-3272731
Email
m.nieuwelink@maartenskliniek.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vivian Weerdesteyn, Prof. dr.
Organizational Affiliation
Sint Maartenskliniek
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sint Maartenskliniek
City
Ubbergen
ZIP/Postal Code
6574NA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marijne Nieuwelink, MSc
Phone
024-3272731
Email
m.nieuwelink@maartenskliniek.nl

12. IPD Sharing Statement

Citations:
PubMed Identifier
32776854
Citation
Kuijpers R, Smulders E, Groen BE, Smits-Engelsman BCM, Nijhuis-Van der Sanden MWG, Weerdesteyn V. Reliability and construct validity of the Walking Adaptability Ladder Test for Kids (WAL-K): a new clinical test for measuring walking adaptability in children. Disabil Rehabil. 2022 Apr;44(8):1489-1497. doi: 10.1080/09638288.2020.1802523. Epub 2020 Aug 10.
Results Reference
background
PubMed Identifier
33915437
Citation
Tuijtelaars J, Roerdink M, Raijmakers B, Nollet F, Brehm MA. Polio survivors have poorer walking adaptability than healthy individuals. Gait Posture. 2021 Jun;87:143-148. doi: 10.1016/j.gaitpost.2021.04.031. Epub 2021 Apr 21.
Results Reference
background
Links:
URL
https://www.maartenskliniek.nl/research-innovation/research-innovation-projecten/attains-trainen-van-het-loopaanpassingsvermogen-bij-mensen-na-een-beroerte
Description
The project description on the website of the Sint Maartenskliniek (where the study will be performed).
URL
https://www.maartenskliniek.nl/research-innovation-en/research-innovation-projects/attains-gait-adaptability-training-for-people-after-stroke
Description
The English description of the project on the website of the Sint Maartenskliniek.

Learn more about this trial

Gait Adaptability Training, Using Augmented Reality, for Individuals in the Chronic Phase After Stroke

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