Methods |
Randomised cross‐over trial nested in a randomised controlled trial
Method of randomisation: online random number generator
Blinding of outcome assessors: no
Adverse events: not reported
Deaths: none
Dropouts
: none
ITT: yes |
Participants |
Country: not reported
8 patients (4 in treatment group, 4 in control group)
Mean age: not reported
Inclusion criteria: diagnosis of PD according to UK PD Brain Bank criteria, written informed consent
Exclusion criteria: severe freezing, MMSE < 24 out of 30, other conditions affecting balance and gait, alternative central nervous diseases affecting gait confirmed by MRI |
Interventions |
Each participant underwent the following conditions (with a washout
period of one week):
(A) a single session of physical training plus sham tDCS, (2 mA for 30s) over Cz area of international 10‐20 EEG electrode placement (Kaski 2012)
(B) a single session of physical training plus anodal tDCS, 2 mA for 15 minutes, over Cz area of international 10‐20 EEG electrode placement |
Outcomes |
Outcomes were recorded at baseline, and after each of the two treatment sessions:
Gait velocity (calculated by the middle four minutes of the 6‐minute walk test)
Gait endurance (6‐minute walk test)
Stride length (video analysis)
Timed Up and Go Test
Postural Instability (Pull test) |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Randomisation by an online randomisation tool |
Allocation concealment (selection bias) |
Unclear risk |
Quote: “Randomization was performed by the unblinded researcher by entering the anonymised patient details into the software prior to the patient’s arrival. This generated a code relating to the intervention arm (physical training vs. no training), and stimulation type (real vs. sham)” |
Blinding of participants and personnel (performance bias)
Objective outcomes |
Low risk |
Participants and personnel were blinded (Kaski 2014 [pers comm]) |
Blinding of participants and personnel (performance bias)
Subjective outcomes |
Low risk |
Participants and personnel were blinded (Kaski 2014 [pers comm]) |
Blinding of outcome assessment (detection bias)
Objective outcomes |
Low risk |
Outcome assessor was blinded to both the grouping (sham and real) and delivery of the stimulation (Kaski 2014 [pers comm]) |
Blinding of outcome assessment (detection bias)
Subjective outcomes |
Unclear risk |
Outcome assessor was blinded to both the grouping (sham and real) and delivery of the stimulation (Kaski 2014 [pers comm]) |
Incomplete outcome data (attrition bias)
Subjective outcomes |
Low risk |
No dropouts occurred |
Selective reporting (reporting bias) |
Unclear risk |
All outcomes reported in the "methods" section have been reported; no protocol could be identified |