None listed
Conditions
Brief summary
Primary objective: To determine whether four weeks of ES cycling in addition to usual care results in greater improvements in quadriceps strength and walking ability in people with an acquired brain injury compared to usual physiotherapy alone. Secondary objective: To determine whether four weeks of ES cycling in addition to usual care improves global lower limb strength and reduces spasticity in people with an acquired brain injury compared to usual physiotherapy alone. The null hypothesis is that application of ES cycling in addition to usual physiotherapy will not improve people’s lower limb strength and walking ability more than usual physiotherapy alone.
Interventions
Electrical Stimulation (ES) Cycling
A 30 min incremental progressive, individualised ES cycling program performed five times a week for four weeks as well as usual care. ES Cycling involves applying a small electrical current through pads attached to the skin over 4 muscle groups on the affected leg. This will be applied from 10-15 minutes initially increasing to 30 minutes 5 times weekly over a 4 week period. The parameters will be individualized and adjusted according to the participants' com
Electrical Stimulation (ES) Cycling A 30 min incremental progressive, individualised ES cycling program performed five times a week for four weeks as well as usual care. ES Cycling involves applying a small electrical current through pads attached to the skin over 4 muscle groups on the affected leg. This will be applied from 10-15 minutes initially increasing to 30 minutes 5 times weekly over a 4 week period. The parameters will be individualized and adjusted according to the participants' comfort levels. It will take approximately 10 minutes to set up a participant on the ES cycle however once set up the therapist will be able to provide one-to-one assistance to other people whilst supervising participants. This will allow more people to receive supervised exercise simultaneously.
Sponsors
Davide de Sousa
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. diagnosis of a first time stroke or any other acquired brain injury that is not progressive resulting in hemiparesis 2. acute event < 6 months before the study onset 3. sufficient cognition to consent (as evaluated by a physician) or consent will be obtained from the next of kin. 4. sufficient communication to indicate yes/no verbally or via gestures possible discomfort. 5. able to sit supported for 40 mins
Exclusion criteria
1. limited joint range of movement or musculoskeletal conditions that would prevent pedaling 2. cardiac pacemakers unless permission to participate by a medical officer 3. skin reaction to the electrodes 4. inability to tolerate or be stimulated by electrical stimulation 5. poor skin viability 6. pregnancy
Outcome results
None listed