| Methods |
Design: Randomised controlled trial, parallel groups.
Randomisation: 'Subjects were assigned to one of two treatment groups using a randomisation procedure that incorporated stratification according to stroke severity'.
Dropouts: n = 1 from control groups as social support system was compromised. |
| Participants |
n = 16.
Experimental: n = 8. Mean age 59.4, range 43‐68, years. Mean years after stroke was 4, range 1‐15.
Control: n = 7 (1 dropout before outcome). Mean age 64.9, range 50‐81, years. Mean years after stroke was 3.7, range 2‐9.
Study criteria: (1) scoring 0‐29 on Fugl‐Meyer Coordination Scale; (2) chronic persistent swing phase deficits characterised by absent or attenuated limb flexion during swing phase; (3) ability to follow 2‐stage commands; (4) endurance to participate in 1.5 hours of therapy, 4 days a week; (5) no peripheral neuropathy; (6) no acute degenerative diseases of musculoskeletal or nervous systems; (7) no allergy to electrode materials; (8) no cardiac pacemaker. |
| Interventions |
Duration: 3 months
Experimental:
Category = 13.
Electrostimulation with intramuscular electrodes implanted into tibialis anterior, peroneur longus/brevis, short head of biceps femoris, semi‐tendonosus and semimembranous or long head of biceps femoris. Experimental participants treated for 3 months with 1.5 hour long sessions given 4 times per week. A specialised computer program was used to individualise the stimulation patterns for each participant. The activation level for each muscle was set according to patient comfort and then according to the movement desired but mostly set to approximate normal joint movement excursion. The stimulation ranges were 30Hz, 4‐20 mA and 5‐150ms. All experimental participants also received the control treatment.
Control: Experimental participants treated for 3 months with 1.5 hour long sessions given 4 times per week. Each session consisted of: (1) 30 minutes strengthening and co‐ordination training; (2) 30 minutes overground gait training; (3) 30 minutes bodyweight supported treadmill gait training.
Comparison: Electrostimulation vs no treatment. |
| Outcomes |
Baseline measurement: Before intervention.
Outcome measurement: After the intervention at 3 months.
Included outcomes: All made without electrostimulation or orthotic devices: (1) peak swing hip flexion; (2) timing of peak hip flexion (% gait cycle); (3) peak swing knee flexion; (4) timing of peak knee flexion (% gait cycle); (5) mid‐swing ankle dorsiflexion; (6) timing of mid‐swing ankle dorsiflexion (% gait cycle). |
| Notes |
Intention‐to‐treat principle was not followed in the analysis. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
