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Efficacy of intensive multidisciplinary rehabilitation in Parkinson's disease: a randomised controlled study |
Ferrazzoli D, Ortelli P, Zivi I, Cian V, Urso E, Ghilardi MF, Maestri R, Frazzitta G |
Journal of Neurology, Neurosurgery, and Psychiatry 2018 Aug;89(8):828-835 |
clinical trial |
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
OBJECTIVE: To evaluate whether a 4-week multidisciplinary, aerobic, motor-cognitive and intensive rehabilitation treatment (MIRT) improves the quality of life (QoL) of patients with Parkinson's disease (PD), in the short-term and long-term period. METHODS: This is a prospective, parallel-group, single-centre, single-blind, randomised clinical trial (ClinicalTrials.gov NCT02756676). 186 patients with PD, assigned to experimental group, underwent MIRT; conversely, 48 patients, assigned to control group, did not receive rehabilitation. Parkinson's Disease Questionnaire-39 was assessed 2 (T0), 10 (T1) and 18 (T2, only experimental group) weeks after the enrolment. We compared T1 versus T0 scores within subjects and delta scores (T1-T0) between subjects. To investigate the long-term effects, we compared T2 and T0 scores in the experimental group. RESULTS: At T0, no between-group differences in the Global Index Score (GBI) were observed (experimental group 43.6 +/- 21.4, controls 41.6 +/- 22.9, p = 0.50). At T1, we did not find significant changes in controls (delta score 1.2 +/- 9.9, p = 0.23), and we found an improvement in GBI in the experimental group (delta score -8.3 +/- 18.0, p < 0.0001), significant also between subjects (p < 0.0001). Comparing T2 versus T0 in the experimental group, the GBI maintained a significant improvement (delta score -4.8 +/- 17.5, p < 0.0001). CONCLUSIONS: A rehabilitation treatment such as MIRT could improve QoL in patients with PD in the short-term and long-term period. Even though the single-blind design and the possible role of the placebo effect on the conclusive results must be considered as limitations of this study, the improvement in outcome measure, also maintained after a 3-month follow-up period, suggests the effectiveness of MIRT on the QoL. CLINICAL TRIAL REGISTRATION: NCT02756676: pre-results.
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