Stroke Clinical Trial
— TARGETOfficial title:
A Temporal Analysis of the Robustness of Hemiplegic Gait and Standing Balance Early After sTroke - the TARGET Research Project
Verified date | April 2022 |
Source | Universiteit Antwerpen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Phase II: Investigating the effects of additional robot-assisted gait training either initiated early (2 weeks post-stroke) or delayed (8 weeks post-stroke) after stroke onset.
Status | Completed |
Enrollment | 19 |
Est. completion date | February 7, 2022 |
Est. primary completion date | February 7, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 - Unable to walk independently at baseline (FAC <3) - Moderate to severe weakness of the lower limb at baseline (MI </=75) - 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 - Body weight > 100 kg - Severe spasticity or contractures that prevent safe use of the exoskeleton - Medically unstable to participate in additional therapy sessions |
Country | Name | City | State |
---|---|---|---|
Belgium | Antwerp University Hospital | Antwerp | |
Belgium | RevArte Rehabilitation Hospital | Antwerp | |
Belgium | GZA Ziekenhuis - campus St Augustinus & Campus St Vincentius | Wilrijk | Antwerp |
Lead Sponsor | Collaborator |
---|---|
Universiteit Antwerpen | University Hospital, Antwerp |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change on the Fugl Meyer motor assessment - subscale lower extremity (FM-LE) | This scale measures the level of of volitional, 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 synergies). |
Longitudinal change is determined between the following time points: 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 | |
Secondary | Trunk Control Test - item sitting balance | 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) |
Baseline (0-1 week post-stroke) | |
Secondary | Motricity Index - subscale lower extremity (MI-LE) | 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). |
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 | |
Secondary | Berg Balance Scale - item standing unsupported | 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). |
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 | |
Secondary | Functional Ambulation Categories (FAC) | 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). |
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 | |
Secondary | Kinetic analyses of standing balance & gait | 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. | 3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke | |
Secondary | EMG analyses of standing balance & gait | 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. | 3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke | |
Secondary | Spatio-temporal analyses of gait | Assessing comfortable (self-selected) speed and spatial/temporal symmetry of gait over a short distance. | 3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke. |
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