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

Sponsor

Universiteit Antwerpen (Other)

Overall Status

Completed

CT.gov ID

NCT03728036

Collaborator

University Hospital, Antwerp (Other)

Enrollment

Locations

39.2

Actual Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Stroke Paresis Gait, Hemiplegic	Behavioral: conventional rehabilitation

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 Design

Study Type:

Observational

Actual Enrollment :

51 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Temporal Analysis of the Robustness of Hemiplegic Gait and Standing Balance Early After sTroke - the TARGET Research Project

Actual Study Start Date :

Nov 1, 2018

Actual Primary Completion Date :

Feb 7, 2022

Actual Study Completion Date :

Feb 7, 2022

Outcome Measures

Primary Outcome Measures

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

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)
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).
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).
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).
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Antwerp University Hospital	Antwerp	Belgium
2	RevArte Rehabilitation Hospital	Antwerp	Belgium
3	GZA Ziekenhuis - campus St Augustinus & Campus St Vincentius	Wilrijk	Belgium	2610

Sponsors and Collaborators

Universiteit Antwerpen
University Hospital, Antwerp

Investigators

Principal Investigator: Jonas Schröder, PhD Student, Dept. Rehabilitation Sciences & Physiotherapy, University of Antwerp, Belgium
Study Director: Wim Saeys, Prof. Dr., Dept. Rehabilitation Sciences & Physiotherapy, University of Antwerp, Belgium
Study Chair: Steven Truijen, Prof. Dr., Dept. Rehabilitation Sciences & Physiotherapy, University of Antwerp, Belgium
Study Chair: Gert Kwakkel, Prof. Dr., Dept. Rehabilitation Medicine, VU University Medical Center, Amsterdam, Netherlands