Stroke Circulatory System Stroke, not specified as haemorrhage or infarction
Conditions
Interventions
After completion of baseline measurements the intervention phase will last for six weeks. All participants will receive conventional physical therapy (CPT) deemed appropriate for their presentation by
Sponsors
University of East Anglia (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants will be recruited from in-patient stroke services and will be followed up until 6 months after stroke wherever they are living. Study criteria are: 1. Aged 18+ years (either sex), 3 - 42 days after stroke, infarct or haemorrhage, confirmed through routine clinical imaging 2. Fit for rehabilitation, i.e., peripheral oxygen saturations 90%+ on air, resting pulse less than 101 beats/minute 3. Walking ability from FAC score 1 to FAC score 5 (section 5) but with: 3.1. Abnormal initial floor contact, and/or 3.2. Impaired ability to take full body weight through the paretic lower limb in stance 4. No contractures at hip, knee, ankle or forefoot or loss of skin integrity over the paretic foot or lower limb. Contracture is defined as persistent loss of full passive range of motion at a joint resulting from structural changes in connective tissues and measured using manual goniometry using the non-paretic lower limb as the comparator. 5. Can follow a 1-stage command, i.e., sufficient communication/orientation for interventions in this trial
Exclusion criteria
Exclusion criteria: Does not meet inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Walking speed: during walking forwards in a straight line at participant-selected speed. Each participant will be asked to undertake 4 walks. Walking speed will be measured in the middle of the walkway using 2 inexpensive infra-red light beams placed 3 metres apart on shoulder-high stands and connected to an electronic timer. Subjects who cannot walk without support, i.e. a FAC score of 2 or less (support of 1 person), will be deemed to have a walking speed of zero. | — |
Secondary
| Measure | Time frame |
|---|---|
| Ability to walk independently, functional mobility, ability to walk with a normal gait pattern and structural brain imaging: 1. Functional Ambulation Category (FAC) ranges from unable to walk (score 0) to able to walk independently on level/non-level surfaces (score 5). This measure is clinically relevant to walking function and has been found to have strong inter-rater and test-retest reliability. 2. Modified Rivermead Mobility Index: This reliable and clinically relevant scale measures functional mobility including turning over in bed, standing up, walking indoors and ascending stairs. This measure is used widely in stroke rehabilitation research. 3. Efficiency of gait measured by: 3.1. Peak angular velocity of the knee during walking as a sensitive objective measure of gait performance 3.2. The ratio of step times on the paretic and non-paretic lower limbs as a measure of temporal symmetry 3.3. The ratio of step lengths on the paretic and non-paretic lower limbs as a measure of spatial symmetry 3.4. The ratio of sagittal angular velocity of the knee of the paretic and contra-lateral lower limbs as a measure of joint symmetry 3.5. The angle of the tibia with respect to the vertical at initial contact, foot flat, mid stance and terminal contact as a measure of smooth forward progression of the lower leg. These measures are made simultaneously with walking speed using the clinical gait analysis equipment (see primary outcome). They can be undertaken easily in a clinical environment using a technique developed by Wall and applied by Rowe and others in which the participant walks across a 10 metre long mat on which a high contrast grid has been printed while being video recorded from the side view. The resultant video can be played back in slow motion and timed using a multi-lap stopwatch to determine the step times. It can also be viewed frame by frame and using the grid the spatial location of the feet during the walk can be determined to give step lengths. The a | — |
Countries
United Kingdom
Outcome results
None listed