| Methods |
Randomised controlled trial
Method of randomisation: software‐generated randomisation list
Blinding of outcome assessors: yes
Adverse events: none
Deaths: none
Drop‐outs: 2 (1 in EXP and 1 in CTL)
ITT: yes |
| Participants |
Country: Italy
30 patients (15 in treatment group, 15 in control group)
Ambulatory at study onset: yes
Mean age: 67 to 68 years (treatment and control group respectively)
Inclusion criteria: diagnosis of PD according to the UK Brain Bank Criteria, disease stage <III according to the classification of Hoehn and Yahr without motor fluctuations, being able to ambulate independently
Exclusion criteria: treadmill training or other form of specific gait training for at least 6 months before the study, treadmill training or other form of specific gait training for at least 6 months before the study, body weight more than 100 kg; respiratory disease; other neurological diseases; dementia; depression; or uncorrected visual disturbances; undergone or planned deep brain stimulation in the following 6 months |
| Interventions |
2 arms:
(1) control group used robotic gait training, 3 times a week for 4 weeks (120 min a week)
(2) experimental group received treadmill training, 3 times a week for 4 weeks (120 min a week) |
| Outcomes |
Outcomes were recorded at baseline and at the end of intervention phase
Primary outcome:
6 Minute walk test
Secondary outcome:
10‐m walk test
Timed Up‐and‐Go test
Unified Parkinson’s Disease Ranking Scale (UPDRS) Motor Score
Global health status (SF‐12 questionnaire) |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
A software‐generated randomisation list was used |
| Allocation concealment (selection bias) |
Low risk |
A researcher not involved in the experiment checked for correct patient allocation prior and after the study |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Quote: “A physical therapist who was not involved in the treatment of the enrolled patients and who was blinded to treatment allocation performed all outcome assessments.” |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Missing data was balanced between groups and an intention‐to‐treat analysis has been performed by the authors |
