Methods |
Design: three group parallel trial
Purpose: study the effect of segmental vs. innocuous electrical stimulation for chronic pain relief |
Participants |
Patients: patients with first acute stroke
Baseline comparability: NS |
Interventions |
Placebo: stimulation from electrical stimulation device with disconnected circuit and standard rehabilitation
Untreated: standard rehabilitation only
Experimental: functional electrical stimulation and standard rehabilitation
(Co‐intervention: standard rehabilitation program) |
Outcomes |
Composite spasticity scale (CSS)
Maximum isometric voluntary contraction (MIVC)
Walking ability (Up and Go (TUG) test) |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Adequate sequence generation? |
Low risk |
'random number produced by Jensen's computerized method of minimization' |
Blinding?
Treatment provider |
High risk |
Described as single‐blind (placebo/electrical stimulus device) |
Blinding?
Outcome assessor |
Low risk |
'... the assessor was blinded to the nature of intervention' |
Incomplete outcome data addressed?
All outcomes |
Low risk |
Drop‐out < 15% |
Free of selective reporting? |
Unclear risk |
No protocol available |
Free of other bias? |
Low risk |
|
Trial size > 49? |
High risk |
N = 28 |
Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |