Please select the eligibility criteria that correspond to the clinical trial below.
Title: How to Improve Walking, Balance and Social Participation Following Stroke: a Comparison of Cane Walking to an Orthosis TheraTogs in Early Post-stroke Gait Rehabilitation. A Multi-centred, Single Blind,Randomized Control Trial.
Brief Summary: Background 9000 people a year in Switzerland suffer a first time stroke. Of these 20 to 30% remain unable to walk and up to 60% are left with moderate to severe walking disability.

Evidence shows that rehabilitation techniques which emphasise use of the hemiplegic side influence ipsilesional cortical plasticity and improve functional outcomes. Canes are commonly used in gait rehabilitation although they significantly reduce hemiplegic muscle activity. We have shown that an orthosis "TheraTogs" ( elastic corset supporting hemiplegic side) significantly increases hemiplegic muscle activity during gait.

To date no clinical studies have investigated the long term effects of these techniques on gait recovery following stroke.

This study aims to determine if advances in the understanding of cortical plasticity and its relation to functional recovery following stroke can be applied to clinical gait rehabilitation to improve long term outcomes.

Hypotheses Early gait rehabilitation with canes will reduce hemiplegic muscle activity and inhibit balance reactions. In the long term this causes poorer walking ability and balance and consequently reduced social participation.

Early gait rehabilitation with TheraTogs will increase hemiplegic muscle activity and facilitate balance reactions. In the long term this improves walking ability and balance leading to increased social independence and participation.

Design Multi-centred, single blind, randomized control trial. Subjects 120 first time stroke patients Intervention When subjects can walk unaided on even ground whilst requiring verbal prompts and stand-by help without body contact (FAC 3) they will be randomly allocated into intervention (TheraTogs) or control (cane) group. TheraTogs will be applied to support hip extensor and abductor musculature according to a standardized procedure. Cane walking with cane at the level of the radial styloid of the sound wrist. Subjects will walk throughout the day with the assigned walking aid. Standard therapy treatments and usual care will remain unchanged and documented.The intervention will continue for five weeks or until patients have reached FAC 5 (independent walkers on all surfaces).

Measures: the day before intervention begin, the day after intervention completion (max 5 weeks), 3 months, 6 months and 2 years after completion Primary outcome Timed "up and go" test Secondary outcomes surface EMG of hemiplegic lower extremity musculature, temporo-spatial gait parameters, hip kinematics, dynamic balance. The Stroke Impact Scale.

Results Significance levels will be 5% with 95% CI's. ITT analyses will be performed. Descriptive statistics will be presented. Relevant co-variables will be identified and analysed. Discussion This study could have significant implications for the clinical practice of gait rehabilitation after stroke in particular the effect and appropriate use of walking aids


Options:
A: Inclusion Criteria:

* Diagnosis of ischemic or hemorrhagic stroke
* age ≥18;
* Functional Ambulation Classification (FAC) ≥3
* Barthel Index ≥45

Exclusion Criteria:

* Cognitive impairment (Mini Mental State Examination ≤24)
* Unstable cardiovascular disease (acute heart failure, recent myocardial infarction, unstable angina and uncontrolled arrhythmias)
* Alcohol or other toxic substances abuse
* Decompensated psychiatric disorders that prevented from following a group session
B: Inclusion Criteria:

* ischemic or hemorrhagic stroke
* within 1 month of discharge from hospital
* able to stand up from a chair with or without gait aid and walk at least 5 metres
* able to understand 2-step commands

Exclusion Criteria:

* Have other neurological problems besides stroke or medically unstable.
C: The inclusion criteria will be as follows:

1. patients with a first time intracerebral (either cortical or subcortical) hemorrhage with unilateral hemiparesis/ hemiplegia confirmed by magnetic resonance imaging or computed tomography;
2. patients with no contraindications to being mobilized (early intervention) within 24 hours of stroke onset (based on the medical team's clinical judgment: including systolic blood pressure (SBP)\<160mmHg in resting; resting heart rate (HR)\<130 bpm; no hydrocephalus; 80\< mean arterial pressure (MAP)\<110 mmHg before intervention);
3. patients with National Institutes of Health Stroke Scale (NIHSS) scores at admission ranging from 1 to 20;
4. patients with total activity of living independence pre-stroke; and
5. patients between 20 and 80 years old.

The exclusion criteria will be as follows:

1. patients with mild to moderate deficits as described above (3);
2. patients who are unable to complete the baseline survey because of serious aphasia, language difficulties, or cognitive deficits;
3. patients with other medical conditions, such as severe heart failure, acute coronary syndrome, or lower-limb disorders, that prevent early mobilization; and
4. patients who are unable to provide informed consent. In addition, we will exclude those showing rapid early deterioration of symptoms, as well as those with a concurrent diagnosis of rapidly deteriorating disease (e.g., terminal cancer).
D: Inclusion Criteria:

* patients with hemiplegia following a first unilateral stroke
* will score at least level 3 on the Functional Ambulation Category (FAC) (able to walk unaided on even ground but requiring verbal prompts and stand-by help without body contact)
* must have been independent walkers prior to insult without walking aids
* Subjects will have a Mini Mental State score of 22 or above

Exclusion Criteria:

* orthopaedic or other neurological conditions that could limit walking ability
* no gross visuospatial or visual field deficits
* no medical contraindications to walking

Answer: D