Retaining Short-term Training Effects on Gait Adaptability in People With Stroke (ATTAINS)

April 11, 2023 updated by: Sint Maartenskliniek

The Effect of Single Booster Sessions or Home-based Exercise Program for Individuals in the Chronic Phase After Stroke to Retain Short-term Training Effects on Gait Adaptability, a Study-protocol.

Background: The majority of stroke survivors regain walking ability. However, the ability to adapt gait patterns to meet environmental demands remains impaired in a majority of people in the chronic phase after stroke. This impaired gait adaptability has a profound impact on activities of daily living and quality of life. Treatment targeting gait adaptability is therefore critical for safe and independent community ambulation in people with stroke. Augmented or virtual reality in rehabilitation programs can be used to train gait adaptability in a controlled situation. A few studies have evaluated gait adaptability training in people with stroke. Although results were promising, these studies did not include an adaptability-related outcome measure, or were limited to uncontrolled or small-scaled pilot studies. Moreover, it is unknown if beneficial training effects can be fostered for 1 year after completion of a training program. We evaluate the short-term effects of a 5-week gait adaptability training in an adequately powered, waiting-list controlled clinical trial [ref naar clin trial nummer]. In the current study, we focus on the retention of potentially beneficial effects of this 5 week gait adaptability training program. We will evaluate if short-term effects of gait adaptability training can be retained through single training sessions to boost performance, or by an home exercise program. We hypothesize that booster sessions and home-based exercise will both yield better retention of training effects at 1 year follow-up as compared to the control arm without an experimental intervention.

Objective: The primary objective of this study is to test the hypothesis that retention of training-induced gains in gait adaptability can be fostered by providing booster sessions or by prescribing home-based training.

Study design: Explorative randomized study, comparing the effect of 3 1-hr booster training sessions against home-based exercise against no intervention on gait adaptability performance 1 year after completion of a 5-week gait adaptability training program.

Study population: Stroke patients in the chronic phase after stroke, who completed the 5-week gait adaptability training using the C-Mill and agreed to continue in this follow-up study. We expect this to be 50-75 participants.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
      • Ubbergen, Netherlands, 6574NA
        • Sint Maartenskliniek

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • > 6 months after first unilateral supratentorial stroke (chronic phase)
  • Able to walk at least 10 minutes independently
  • Initial involvement of the lower extremity after stroke.
  • Having completed (minimal 8/10 training sessions) the 5 week gait adaptability training program using the C-Mill

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.
  • Severe cognitive or visuo-spatial impairments limiting comprehension of instructions or correct perception of the environments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Booster group
Participants assigned to the booster group will receive a three single training sessions 3 months apart targeting gait adaptability using the C-mill. Assessments will take place after giving informed consent which is indicated as the start of the study (baseline), 6 months and 12 months post-baseline.
Behavioral: Gait adaptability training
Over a span of 1 year participants will receive 3 one hour, single sessions at 3, 6 and 9 months following baseline assessment, of gait adaptability training, 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 trained.
Experimental: Home-based exercise group
Participants assigned to the home-based exercise group will receive a program for training at home aiming at a minimum training time of 60 minutes per week. Assessments will take place after giving informed consent which is indicated as the start of the study (baseline), 6 months and 12 months post-baseline
Behavioral: Home-based exercise training
Participants will receive tailored exercise through an online platform targeting gait adaptability. Participants are instructed to train at a minimum of 60 minutes per week, with a frequency of 2 sessions per week. Participants will be supported through tele-consultations on a monthly basis for the first 3 months and bi-monthly for the remaining time of the study. These consultations are focused on technical support, on ways to ensure training progression and to encourage adherence to the program.
No Intervention: Control group
Participants assigned to the control group will not follow any additional intervention other than the standard care they already receive for the year following the completion of the 5-week gait adaptability training using the C-Mill from the ATTAINS study. Assessments will take place after giving informed consent which is indicated as the start of the study(baseline), 6 months and 12 months post-baseline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Walking Adaptability Ladder Test (WALT) score
Time Frame: 12 months post-baseline
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.
12 months post-baseline
Emory Functional Ambulation Profile (EFAP) score
Time Frame: 12 months post-baseline
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
12 months post-baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lab-based walking adaptability test
Time Frame: 12 months post-baseline
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.
12 months post-baseline
Balance performance
Time Frame: 12 months post-baseline
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).
12 months post-baseline
Walking performance
Time Frame: 12 months post-baseline
Measure of walking ability using the 10meter walktest, measured in seconds where a lower score is a better outcome.
12 months post-baseline
Balance confidence
Time Frame: 12 months post-baseline
Evaluating balance confidence using the Activity Balance Scale, measured on a 0% - 100% scale, where a higher score is a better outcome.
12 months post-baseline
Daily life gait performance as assessed by gait quality
Time Frame: 12 months post-baseline
Measured by inertial measurement units placed on both feet and the lower back. Analysis through cusomized algorythms.
12 months post-baseline
Daily life walking activity assessed by walking time per day
Time Frame: 12 months post-baseline
Average time of walking during the day (minutes) measured in one week using the Activ8.
12 months post-baseline
Health-related quality of life
Time Frame: 12 months post-baseline
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.
12 months post-baseline
Balance performance through MiniBESTest
Time Frame: 12 months post-baseline
Measure of balance and gait stability using the Mini Balance Evaluation Systems Test (MiniBESTes). Tasks are score on a 3-point scale. Outcome is an average score ranging between 0 and 1 where a higher score is a better outcome.
12 months post-baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sint Maartenskliniek

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development

Investigators

  • Principal Investigator: Vivian Weerdesteyn, Prof. dr., Sint Maartenskliniek

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

April 11, 2023

First Submitted That Met QC Criteria

April 11, 2023

First Posted (Actual)

April 24, 2023

Study Record Updates

Last Update Posted (Actual)

April 24, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL80178.091.21 / 0996_2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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