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Original Investigation |

Physiotherapy and Occupational Therapy vs No Therapy in Mild to Moderate Parkinson Disease A Randomized Clinical Trial

Carl E. Clarke, MD1,2; Smitaa Patel, MSc3; Natalie Ives, MSc3; Caroline E. Rick, PhD3; Francis Dowling, BSc3; Rebecca Woolley, MSc3; Keith Wheatley, DPhil4; Marion F. Walker, PhD5; Catherine M. Sackley, PhD6 ; for the PD REHAB Collaborative Group
[+] Author Affiliations
1School of Clinical and Experimental Medicine, College of Medical and Dental Sciences, University of Birmingham, Birmingham, England
2Department of Neurology, Sandwell and West Birmingham Hospitals NHS Trust, City Hospital, Birmingham, England
3Birmingham Clinical Trials Unit, College of Medical and Dental Sciences, University of Birmingham, Birmingham, England
4Cancer Research UK Clinical Trials Unit, College of Medical and Dental Sciences, University of Birmingham, Birmingham, England
5University of Nottingham, Nottingham, England
6King’s College, London, England
JAMA Neurol. 2016;73(3):291-299. doi:10.1001/jamaneurol.2015.4452.
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Importance  It is unclear whether physiotherapy and occupational therapy are clinically effective and cost-effective in Parkinson disease (PD).

Objective  To perform a large pragmatic randomized clinical trial to evaluate the clinical effectiveness of individualized physiotherapy and occupational therapy in PD.

Design, Setting, and Participants  The PD REHAB Trial was a multicenter, open-label, parallel group, controlled efficacy trial. A total of 762 patients with mild to moderate PD were recruited from 38 sites across the United Kingdom. Recruitment took place between October 2009 and June 2012, with 15 months of follow-up.

Interventions  Participants with limitations in activities of daily living (ADL) were randomized to physiotherapy and occupational therapy or no therapy.

Main Outcomes and Measures  The primary outcome was the Nottingham Extended Activities of Daily Living (NEADL) Scale score at 3 months after randomization. Secondary outcomes were health-related quality of life (assessed by Parkinson Disease Questionnaire–39 and EuroQol-5D); adverse events; and caregiver quality of life. Outcomes were assessed before trial entry and then 3, 9, and 15 months after randomization.

Results  Of the 762 patients included in the study (mean [SD] age, 70 [9.1] years), 381 received physiotherapy and occupational therapy and 381 received no therapy. At 3 months, there was no difference between groups in NEADL total score (difference, 0.5 points; 95% CI, −0.7 to 1.7; P = .41) or Parkinson Disease Questionnaire–39 summary index (0.007 points; 95% CI, −1.5 to 1.5; P = .99). The EuroQol-5D quotient was of borderline significance in favor of therapy (−0.03; 95% CI, −0.07 to −0.002; P = .04). The median therapist contact time was 4 visits of 58 minutes over 8 weeks. Repeated-measures analysis showed no difference in NEADL total score, but Parkinson Disease Questionnaire–39 summary index (diverging 1.6 points per annum; 95% CI, 0.47 to 2.62; P = .005) and EuroQol-5D score (0.02; 95% CI, 0.00007 to 0.03; P = .04) showed small differences in favor of therapy. There was no difference in adverse events.

Conclusions and Relevance  Physiotherapy and occupational therapy were not associated with immediate or medium-term clinically meaningful improvements in ADL or quality of life in mild to moderate PD. This evidence does not support the use of low-dose, patient-centered, goal-directed physiotherapy and occupational therapy in patients in the early stages of PD. Future research should explore the development and testing of more structured and intensive physical and occupational therapy programs in patients with all stages of PD.

Trial Registration  isrctn.org Identifier: ISRCTN17452402

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Figure 1.
CONSORT Diagram for PD REHAB Trial

Patient recruitment and follow-up. Numbers of patients assessed for eligibility and excluded are not included in the flow diagram because screening logs are not available for this trial, so these data cannot be provided. NEADL indicates Nottingham Extended Activities of Daily Living; OT, occupational therapy; PT, physical therapy; PD, Parkinson disease.

aEight patients randomized to the PT and OT group were later found to be ineligible because they had received PT and/or OT for PD in the 12 months prior to randomization (exclusion criteria). One patient did not receive any PT or OT after randomization (crossover; only baseline data available: diagnosed as having cancer and died at 5 months after randomization). One patient did not receive PT or OT within 3 months but was referred for PT outside of the trial at 6 months (3-, 9-, and 15-month data available). The other 6 patients all received PT and/or OT after randomization (baseline and 3-month data available except for 1 patient, where only baseline data were available).

bThree patients randomized to the no therapy group were subsequently found to be ineligible because they had received PT and/or OT for PD in the 12 months prior to randomization (exclusion criteria). One patient received PT and/or OT within 3 months of randomization (crossover). For all 3 patients, baseline and 3-month data were available.

cThirteen patients randomized to the PT and OT group are known to have not received any PT or OT. Baseline and 3-month data are available for 2 of these patients (for the other 11 patients, only baseline data are available). Twelve patients did not receive PT or OT by 3 months after randomization but did start therapy after 3 months; baseline and 3-month data are available for all patients (except 2, 1 of whom had baseline data only and 1 who had 3-month data only).

dNine patients randomized to no therapy had some PT and/or OT before their 3-month NEADL form was completed; all patients had baseline and 3-month data available.

ePartially withdrawn patients did not want to complete patient forms but agreed to clinical follow-up.

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Figure 2.
Medium-term Scores in Activities of Daily Living and Quality of Life

EQ-5D indicates EuroQol-5D; NEADL, Nottingham Extended Activities of Daily Living; OT, occupational therapy; PDQ-39, Parkinson Disease Questionnaire–39; PT, physical therapy; QoL, quality of life.

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