Ignite Creation Date:
2024-05-06 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05825053
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-04-24
First Post:
2023-04-11
Brief Title:
Retaining Short-term Training Effects on Gait Adaptability in People With Stroke
Sponsor:
Sint Maartenskliniek
Organization:
Sint Maartenskliniek
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATTAINS
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None