Stroke Circulatory System Stroke, not specified as haemorrhage or infarction
Conditions
Interventions
The intervention phase will be 20 treatment sessions delivered within a 6-week period, after the completion of baseline measurements. Interventions will follow the agreed protocols, and research thera
Sponsors
Keele University (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Able to provide written informed consent 2. Adult stroke survivors (aged 18 years or older), male or female, with anterior or posterior circulation stroke, occurring 42-112 days (6-16 weeks) earlier 3. Ability to walk independently prior to stroke 4. Participants must also be able to follow simple commands and imitate actions, using the non-paretic upper limb (the arm that has not been affected by the stroke) 5. Participants must be unable to step on and off a 7.5 cm high block more than 12 times in 15 seconds with either their paretic (affected) or non-paretic leg (Step test, Hill et al 1996)
Exclusion criteria
Exclusion criteria: 1. Pre-existing conditions affecting sensation (feeling) of the foot and lower limb e.g. diabetic neuropathy, polyneuropathy (degeneration of the peripheral [not in the brain and spinal cord] nerves), peripheral nerve lesion [injury to a peripheral nerve], previous stroke affecting sensation of the lower limb 2. Fixed contracture of the tendoAchillis, assessed by being unable to achieve 90 degrees dorsiflexion at the ankle, either actively or passively with the knee extended 3. Pressure sores or ulcers on the foot or ankle (hemiparetic limb) 4. Deep vein thrombosis, because some of the MTS techniques would be contraindicated 5. Other conditions that affect the blood supply to/from the foot e.g. heart failure with peripheral oedema 6. Botulinum toxin injections to the lower limb in the previous six months 7. Pain sufficient to prevent delivery of treatments or outcomes 8. Known HIV, Hepatitis non-A or related condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study outcomes include assessment of whether the way participants are recruited is effective, the number of people who consent to participate, the willingness of participants to be randomized, how acceptable the treatments are, how many participants drop out, and to work out how many people would need to be recruited in a future larger trial. As this is a feasibility trial one of the objectives is to identify which measure should be the primary outcome measure for future trials. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Characterization of clinical presentation of participants (to give an overview of the participants to assist with evaluation of the interventions) using the following measurement tools: 1.1. National Institutes of Health Stroke Scale (NIHSS) - This includes assessment of the level of consciousness, vision, motor activity (face, arm and leg), coordination, sensation and speech. Timepoint: Baseline 1.2. Functional Ambulation category, which assesses walking ability and categorizes according to basic motor skills necessary for functional walking. It is anticipated that the step test will exclude people who would achieve a FAC level 6, requiring assessment on uneven surfaces and stairs. Timepoints: Baseline, on completion of the twenty treatments and at one-month follow up. 2. Sensorimotor impairment: The following outcome measurements will be undertaken at baseline, after 5, 10, 15 and 20 treatments and one-month (+/-7 days) after last treatment (treatment number 20). 2.1. Pressure under the feet during stance phase of walking (measured with insoles). This is important to measure because in order to walk there is a dependence upon the interaction between the feet and the environment. 2.2. Ankle range of motion (dorsiflexion and plantarflexion) during stance phase. This will be measured by an electrogoniometer (an electronic piece of equipment), in stance phase of walking. 2.3. Touch/pressure sensory thresholds (sole of foot) (the ability to feel at different points on the sole) of the foot This will be measured using Semmes Weinstein Monofilaments. This involves touching the sole of the foot using a monofilament nylon wire which exerts a force when bowed into a C shape against the skin for 1 second. 2.4. Lower Extremity Motricity Index. This will measure motor impairment (strength) of hip flexors, knee extensors and ankle d | — |
Countries
England, United Kingdom
Outcome results
None listed