Sensory stimulation of the foot and ankle early post-stroke: a feasibility study
- Conditions
- StrokeCirculatory SystemStroke, not specified as haemorrhage or infarction
- Registration Number
- ISRCTN13676183
- Lead Sponsor
- Keele University (UK)
- Brief Summary
2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/34863297/ Description of PPI activities (added 06/12/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34290663/ (added 06/12/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 34
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)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 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.<br><br> As this is a feasibility trial one of the objectives is to identify which measure should be the primary outcome measure for future trials.<br>
- Secondary Outcome Measures
Name Time Method