What do Stroke Survivors Actually Learn When Regaining Walking Ability After Stroke? The TARGET Phase I Study

Completed

• Conditions: Gait, Hemiplegic; Stroke; Paresis

• Registration Number: NCT03728036
• Lead Sponsor: Universiteit Antwerpen

Brief Summary

Phase I: Exploring what stroke survivors exactly learn when recovering the ability to stand and walk.

Detailed Description

GENERAL:

Pre-clinical research has pointed towards a time window of enhanced responsiveness to therapy early after stroke. For example, training has led to substantial recovery if initiated 5 or 14, but not 30 days post-stroke in a rodent model (Biernaski 2004). It is suggested that this early period is characterized by heightened levels of plasticity and that training can exploit this leading to improved outcome. The typically observed non-linear recovery pattern in stroke survivors (Kwakkel 2004) might suggest that similar mechanisms are induced in the human brain, however clinical research on this is disappointingly sparse.

In two closely inter-related phases, we aim to examine the biomechanical changes related to walking recovery in general (Phase I) and the specific effects of robot-assisted training (Phase II). By that, we aim to detect a time window in stroke survivors which resembles the same characteristics as observed in animal models. To initiate gait training at an early stage, when patients usually present severe weakness and balance deficits, a mobile exoskeleton is used which is developed to provide intensive walking practice.

OBJECTIVES:

(I.a) Is there a distinct time window of behavioral restitution (i.e., returning towards pre-stroke movement patterns) underlying early walking recovery?

(I.b) Are improvements in standing and walking throughout the first 6 months post-stroke explained by behavioral restitution or learning to use compensation strategies?

Study Timeline

• Study First Submitted: 2018-10-24
• Study First Submitted QC: 2018-10-31
• Study Start: 2018-11-01
• Study First Posted: 2018-11-01
• Primary Completion: 2022-02-07
• Study Completion: 2022-02-07
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-22
• Last Update Posted: 2022-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• First-ever, MRI- or CT-confirmed, ischemic or hemorrhagic, anterior circulation stroke
• Age: 18 - 90 years
• Baseline assessments within the first 14 days after stroke onset
• Weakness of the lower limb (NIHSS item >0 at 72 hours post-stroke)
• Pre-morbid independence in activities of daily living (mRS </=2) and gait (FAC >3)
• Able to communicate and comprehend
• Sufficient motivation to participate
• Provided a written informed consent

Exclusion Criteria

• No other neurological condition affecting motor functions of the lower limbs
• Pre-existing musculoskeletal impairment severely affecting the gait pattern

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional Ambulation Categories	12 weeks post-stroke]	This scale indicates the ability to walk independently and serves as the primary outcome measure.

Secondary Outcome Measures

Name	Time	Method
Motricity Index - subscale lower limb	Baseline (0-1 week post-stroke), 3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke	Strength of major muscle groups of the paretic lower limb is assessed. At baseline this is part of the prognostic model used to stratify patients.; Scoring: This scale is scored from 0 (no muscle activity) to 99 (normal strength over full range of motion in hip flexors, knee extensors and ankle dorsiflexors).
EMG analyses of standing balance & gait	3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke	EMG analyses will be performed to gain insights in the muscle recruitment of patients during standing and walking. These analyses are used to distinguish between behavioral restitution and the use of compensation strategies.
Spatio-temporal analyses of gait	3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke.	Assessing comfortable (self-selected) speed and spatial/temporal symmetry of gait over a short distance.
Fugl Meyer Motor Assessment - subscale lower limb	Baseline (0-1 week post-stroke), 3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke	This scale measures the level of of selective control of muscles of the paretic lower limb.; Scoring: This scale is scored from 0 (no reflex activity) to 34 (volitional movement out of synergism).
Functional Ambulation Categories	Baseline (0-1 week post-stroke), 3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke	This scale indicates the ability to walk independently and therefore reflects the process of functional walking recovery within the first 6 months post-stroke.; Scoring: This scale includes 6 levels (0-5), ranging from "nonfunctional ambulation" (0) to "ambulate independently, on level and non-level surfaces including stairs and inclines" (5).
Kinetic analyses of standing balance & gait	3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke	Dual-force plate measurements are able to indicate the adopted control strategies for standing balance and walking. These analyses are used to distinguish between behavioral restitution and the use of compensation strategies.
Trunk Control Test - item sitting balance	Baseline (0-1 week post-stroke)	Sitting balance is part of the prognostic model used to stratify patients at baseline.; Scoring: 0 - 1 (able to sit independently without support of the legs or trunk 30 seconds)
Berg Balance Scale - item standing unsupported	Baseline (0-1 week post-stroke), 3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke	This item of the BBS indicates the ability to stand independently and therefore reflects the process of functional walking recovery within the first 6 months post-stroke.; Scoring: This scale includes 5 levels (0-4), ranging from "unable to stand 30 seconds unassisted" (0) to "able to stand safely 2 minutes" (5).

Trial Locations

Locations (3)

RevArte Rehabilitation Hospital; 🇧🇪 Antwerp, Belgium

GZA Ziekenhuis - campus St Augustinus & Campus St Vincentius; 🇧🇪 Wilrijk, Belgium

Antwerp University Hospital; 🇧🇪 Antwerp, Belgium