| Methods |
Design: Randomised controlled trial, parallel groups.
Randomisation: Twenty were randomised to the experimental group and the remaining 18 acted as a control group.
Dropouts: None reported. |
| Participants |
n = 38, mean 25 (11‐41) days after stroke.
Experimental: n = 20, 12 male. Mean age 65 (SD 9) years. Mean time after stroke 25 (11‐37) days.
Control: n = 18, 16 male. Mean age 68 (SD 9) years. Mean time after stroke 26 (15‐41) days.
Study criteria: (1) weakness of dorsiflexion grade 4 or less on MRC scale; (2) CT confirmed cerebral infarction; (3) to remain as in‐patients for at least 4 weeks; (4) no significant cardiac disease or cardiac conduction disturbance; (5) no peripheral neuropathy; (6) no significant medical conditions likely to interfere with completion of the study; (7) no major psychiatric, behavioural disturbances, aphasia or cognitive loss; (8) no previous stroke with residual deficit; (9) no severe deformity or obesity of the lower limbs that might prevent adequate electrical stimulation; (10) no ankle plantar flexion contractures of 5 degrees or more; (11) no severe hemisensory loss or higher level dysfunction. |
| Interventions |
Duration: 4 weeks.
Experimental:
Category 5 + category 7.
FES to common peroneal nerve during walking and cyclical stimulation to produce dorsiflexion of the ankle in the affected leg. FES (category 5) was given 3 days a week for 20 minute sessions. The FES stimulation was given at a frequency of 30‐50Hz and duration of 0.3ms. The stimulus was co‐ordinated to assist passive, active and active assisted exercises and functional activities. Stimulus intensity was adjusted to achieve a maximal contraction against gravity but within each participant's tolerance. The cyclical electrostimulation cycle was 10 seconds on, 30 seconds off, frequency of 30‐50Hz and duration 0.3ms. Stimulus intensity adjusted to achieve a maximal contraction against gravity but within each participant's tolerance. The time for electrostimulation was gradually increased to between 30 and 40 minutes a day over several days according to participant tolerance. All experimental participants also received the control intervention.
Control: physical therapy consisting of passive movements to affected leg or active assisted exercise depending of each participant's ability. Therapy also included functional exercises such as rolling and gait training.
Comparison: Electrostimulation vs no treatment. |
| Outcomes |
Baseline measurement: At entry into the study.
Outcome measurement: After the 4 week intervention.
Included outcomes: (1) Barthel Index; (2) Fugl‐Meyer Lower Limb Assessment
Other outcomes: (1) Massachusetts General Hospital Functional Ambulation Classification. |
| Notes |
Combined two forms of electrostimulation, category 5 and category 7. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
